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Latest FDA New Drug Application News

FDA Approves Tiziana Life Sciences Phase 2 IND for Multiple System Atrophy

August 11
Last Trade: 1.97 -0.03 -1.50

NEW YORK, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, is pleased to announce that the U.S. Food & Drug Administration (FDA) have approved the IND for its Phase 2a clinical trial of intranasal...Read more


Arvinas Announces FDA Acceptance of the New Drug Application for Vepdegestrant for the Treatment of ESR1m, ER+/HER2- Advanced Breast Cancer

August 8
Last Trade: 7.09 0.01 0.14

Filing based on pivotal Phase 3 VERITAC-2 clinical trial demonstrating statistically significant and clinically meaningful improvement in median progression-free survival versus fulvestrant  Vepdegestrant is the first PROteolysis TArgeting Chimera (PROTAC) to demonstrate clinical benefit in patients with breast cancer  NEW HAVEN, Conn., Aug. 08, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today with its partner...Read more


Cingulate Submits New Drug Application to FDA for Lead ADHD Asset CTx-1301

August 6
Last Trade: 4.04 -0.09 -2.18

Regulatory filing marks significant milestone for medication designed to provide once-daily, entire active-day symptom control in ADHD patients KANSAS CITY, Kan., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today...Read more


Lantern Pharma's Subsidiary, Starlight Therapeutics, Announces U.S. Food and Drug Administration Clearance of IND for Phase Ib/2a Glioblastoma Multiforme (GBM) Trial

August 6
Last Trade: 4.57 0.00 0.00

Novel combination therapy with STAR-001 targets the most aggressive and deadliest forms of brain cancer at first progression GBM represents an annual market opportunity of $3 to $5 billion USD with an accelerating number of cases globally Lantern Pharma has previously received both FDA Orphan and Fast Track Designations in GBM DALLAS / Aug 06, 2025 / Business Wire / Starlight Therapeutics, a wholly owned subsidiary of Lantern Pharma...Read more


Lantheus Announces FDA Acceptance of NDA for New Formulation for Market-Leading PSMA PET Imaging Agent

August 6
Last Trade: 54.18 -0.29 -0.53

Designed to expand PSMA PET imaging access for patients by increasing batch size by ~50% and enhancing supply resilience PDUFA date set for March 6, 2026 BEDFORD, Mass., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced that...Read more


CASI Pharmaceuticals Announces FDA Clearance of IND Application for CID-103 in Renal Allograft Antibody-Mediated Rejection (AMR)

August 4
Last Trade: 2.33 0.39 20.10

CID-103 is a potential best-in-class, anti-CD38 monoclonal antibody; binds to unique CD38 epitope Phase 1 study in adults with active and chronic active renal allograft AMR planned to initiate AMR is a leading cause of kidney transplant loss, leading to dialysis and/or repeat renal transplant SAN FRANCISCO, CA / ACCESS Newswire / August 4, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage...Read more


Anixa Biosciences Announces Commencement of US FDA Approved IND Transfer to Support Upcoming Phase 2 Breast Cancer Vaccine Trial

August 4
Last Trade: 2.97 0.00 0.00

Progress Follows Positive Immune Response Observed in Phase 1 Study SAN JOSE, Calif., Aug. 4, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that, in collaboration with Cleveland Clinic, it has initiated the transfer of the Investigational New Drug (IND) application that supported the Phase 1...Read more


AbbVie Submits for U.S. FDA Approval of Combination Treatment of VENCLEXTA® (venetoclax) and Acalabrutinib for Previously Untreated Patients with Chronic Lymphocytic Leukemia (CLL)

July 29
Last Trade: 206.69 2.01 0.98

Combination therapy has potential to be an all-oral, fixed-duration regimen for previously untreated patients with CLL Application is supported by data from the Phase 3 AMPLIFY trial that showed statistically significant improvement in progression-free survival vs chemoimmunotherapy Regimen offers an opportunity for patients to take time off treatment, an important step toward improved disease management NORTH CHICAGO, Ill., July...Read more


MIRA Pharmaceuticals Announces FDA Clearance of IND for Ketamir-2, Enabling U.S. Clinical Trials in Neuropathic Pain

July 29
Last Trade: 1.50 0.03 2.04

Oral, non-opioid drug candidate advancing through Phase 1 and nearing completion of the single ascending dose (SAD) portion as the Company prepares to launch U.S. Phase 2a by year-end MIAMI, FLORIDA / ACCESS Newswire / July 29, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a clinical-stage pharmaceutical company developing novel therapies for neurologic, neuropsychiatric, and metabolic disorders, today announced that the U.S. Food...Read more


Zymeworks Announces FDA Clearance of Investigational New Drug Application for ZW251, a Novel Glypican 3-Targeted Topoisomerase 1 Inhibitor Antibody-Drug Conjugate

July 28
Last Trade: 14.36 0.06 0.42

Second antibody-drug conjugate (ADC) to progress into clinical development utilizing our proprietary payload and optimized antibody Preclinical results demonstrate strong anti-tumor activity and favorable tolerability profile Phase 1 clinical trial evaluating ZW251 in hepatocellular carcinoma (HCC) expected to be initiated in 2025 VANCOUVER, British Columbia, July 28, 2025 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a...Read more


Protagonist Therapeutics Announces Submission of NDA for First Icotrokinra U.S. FDA Approval Aiming to Revolutionize Treatment Paradigm for Adults and Adolescents with Plaque Psoriasis

July 21
Last Trade: 56.07 1.08 1.96

Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor Filing based on unprecedented data package that met all primary endpoints across four Phase 3 studies, including head-to-head superiority comparisons versus deucravacitinib and evaluation of difficult to treat skin sites Submission underscores potential to offer moderate-to-severe plaque psoriasis patients the standout...Read more


Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis

July 21
Last Trade: 176.64 1.92 1.10

Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor Filing based on unprecedented data package that met all primary endpoints across four Phase 3 studies, including head-to-head superiority comparisons versus deucravacitinib and evaluation of difficult to treat skin sites Submission underscores potential to shift the treatment paradigm for moderate-to-severe plaque...Read more


Disc Medicine Announces Positive Pre-NDA Meeting and Confirms Plans to Submit NDA for Bitopertin in Erythropoietic Protoporphyria (EPP) in October 2025

July 21
Last Trade: 59.86 -0.86 -1.42

WATERTOWN, Mass., July 21, 2025 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced positive feedback from its pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) to discuss the planned NDA submission for...Read more


BioXcel Therapeutics Submits Pre-Supplemental New Drug Application Meeting Package in Support of Potential Label Expansion for IGALMI®

July 21
Last Trade: 5.46 0.71 14.95

Company focused on obtaining approval for outpatient (at-home) use of IGALMI® for the acute treatment of agitation associated with bipolar disorders or schizophrenia Pre-Supplemental New Drug Application meeting with FDA scheduled for August 20, 2025 NEW HAVEN, Conn., July 21, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative...Read more


Bristol Myers Squibb’s Supplemental New Drug Application (sNDA) for Sotyktu (deucravacitinib) for the Treatment of Adults with Active Psoriatic Arthritis Accepted for Review Across Four Regions Globally

July 21
Last Trade: 48.44 0.63 1.32

Applications supported by positive results from the pivotal Phase 3 POETYK PsA-1 and POETYK PsA-2 clinical trials, in which significantly more patients treated with Sotyktu achieved ACR20 response compared with placebo at Week 16 U.S. Food and Drug Administration assigned a target action date of March 6, 2026 PRINCETON, N.J. / Jul 21, 2025 / Business Wire / Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug...Read more


Johnson & Johnson receives U.S. FDA Priority Review for TAR-200 NDA in high-risk non-muscle invasive bladder cancer

July 17
Last Trade: 176.64 1.92 1.10

New Drug Application supported by results from the Phase 2b SunRISe-1 study RARITAN, N.J., July 17, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) granted Priority Review to the New Drug Application (NDA) filed for TAR-200, an intravesical gemcitabine releasing system, for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk...Read more


Aldeyra Therapeutics Announces FDA Acceptance for Review of Reproxalap New Drug Application for the Treatment of Dry Eye Disease

July 17
Last Trade: 5.39 0.09 1.70

PDUFA Target Action Date December 16, 2025 LEXINGTON, Mass. / Jul 17, 2025 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of dry eye disease. The FDA...Read more


Corcept Therapeutics Submits New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer

July 14
Last Trade: 71.75 -0.25 -0.35

REDWOOD CITY, Calif. / Jul 14, 2025 / Business Wire / Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its proprietary, selective...Read more


U.S. FDA Accepts New Drug Application for Merck’s Doravirine/Islatravir, an Investigational, Once-Daily, Oral, Two-Drug Regimen for Treatment of Adults with Virologically Suppressed HIV-1 Infection

July 10
Last Trade: 84.21 1.45 1.75

Doravirine/islatravir would be the first FDA-approved two-drug regimen without an integrase inhibitor that demonstrated non-inferior efficacy and a generally comparable safety profile to the three-drug InSTI-based regimen, BIC/FTC/TAF, in a Phase 3 pivotal trial RAHWAY, N.J. / Jul 10, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug...Read more


Solid Biosciences Announces FDA IND and Health Canada CTA Approval for First-in-Class Cardiac Gene Therapy to Treat Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)

July 8
Last Trade: 6.11 -0.06 -0.97

SGT-501 is a novel gene therapy for rare, life-threatening, genetic arrhythmogenic disease with no approved therapies  SGT-501 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA  Solid expects to initiate Phase 1b clinical trial of SGT-501 in the fourth quarter of 2025  Expands Solid’s clinical pipeline to include first cardiac indication with urgent unmet medical...Read more


Longeveron Announces U.S. FDA Approval of IND Application for a Phase 2 Pivotal Registration Study Evaluating Laromestrocel as a Treatment of Pediatric Dilated Cardiomyopathy (DCM)

July 8
Last Trade: 0.75 -0.0022 -0.29

Accepted IND application allows for development program to move directly to a Phase 2 pivotal registration clinical trial Phase 2 clinical trial initiation anticipated in first half of 2026 Pediatric cardiomyopathies affect at least 100,000 children worldwide Effective treatment options are limited, with nearly 40% of children with DCM requiring a heart transplant or dying within two years of diagnosis MIAMI, July 08, 2025 (GLOBE...Read more


Johnson & Johnson: Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo

July 8
Last Trade: 176.64 1.92 1.10

Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in adults with schizophrenia compared to placebo CAPLYTA® is FDA approved to treat schizophrenia and is the first and only approved treatment for bipolar I and II depression as an adjunctive and monotherapy With the addition of CAPLYTA® to Johnson & Johnson's robust portfolio of therapies, the Company now offers the broadest...Read more


Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-600 (Desmopressin Oral Solution)

July 8
Last Trade: 17.04 0.31 1.85

NDA assigned a Target Action Date of February 25, 2026 Product has patent protection through 2044  DEER PARK, Ill., July 08, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the Company’s New Drug Application (NDA) for ET-600, a proprietary patented formulation...Read more


Instil Bio Announces U.S. F.D.A. Clearance of Investigational New Drug (IND) Application for AXN-2510, a PD-L1xVEGF Bispecific Antibody, for a Phase 1 Trial in Relapsed/Refractory Solid Tumors

July 2
Last Trade: 27.84 -0.41 -1.45

US phase 1 trial of ‘2510 is expected to be initiated before the end of 2025 Anticipate ImmuneOnco sharing initial safety and efficacy results from phase 2 trial of ‘2510 + chemo in 1L NSCLC in the second half of 2025 DALLAS, July 02, 2025 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (“Instil”) (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies, today announced the clearance of...Read more


Rocket Pharmaceuticals Announces FDA IND Clearance of RP-A701 for the Treatment of BAG3-associated Dilated Cardiomyopathy

June 30
Last Trade: 3.05 0.02 0.66

RP-A701 is a first-in-class gene therapy for the treatment of BAG3-associated dilated cardiomyopathy BAG3-associated dilated cardiomyopathy is a rare, inherited heart condition caused by mutations in the BAG3 gene, leading to early-onset, progressive heart failure due to impaired cardiac function, high morbidity, and premature mortality Rocket plans to conduct a Phase 1 trial in the U.S. and is working towards the first patient...Read more


Achieve Life Sciences Announces Submission of NDA to FDA for Cytisinicline as a Treatment of Nicotine Dependence for Smoking Cessation

June 26
Last Trade: 2.55 0.00 0.00

Smoking, the leading cause of preventable death and disease, continues to affect nearly 29 million adults in the U.S. alone If approved, cytisinicline will be the first new FDA-approved pharmacotherapy option for nicotine dependence in two decades More than 2,000 clinical trial participants contributed to the body of evidence submitted in the NDA demonstrating cytisinicline’s efficacy, safety, and tolerability profile SEATTLE and...Read more


Grace Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for GTx-104

June 25
Last Trade: 3.26 0.18 5.84

Submission Seeks Approval of GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH) Comprehensive Data Package Includes Positive Results from Phase 3 STRIVE-ON Safety Trial of GTx-104 Submission Has the Potential to Trigger Exercise of up to $7.6 million in Gross Proceeds from 2023 Financing Warrants Tied to FDA Acceptance of NDA for Review PRINCETON, N.J., June 25, 2025 (GLOBE NEWSWIRE) -- Grace...Read more


Corvus Pharmaceuticals Announces Partner Angel Pharmaceuticals Received IND Approval for a Phase 1b/2 Clinical Trial of Soquelitinib in China for the Treatment of Atopic Dermatitis

June 25
Last Trade: 5.43 0.58 11.96

Trial will be conducted by Angel Pharma and will study 12-week dosing of soquelitinib in patients with moderate-to-severe atopic dermatitis SOUTH SAN FRANCISCO, Calif., June 25, 2025 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that the IND application submitted by its partner in China, Angel Pharmaceuticals Ltd. (Angel Pharma), has been...Read more


Plus Therapeutics Announces FDA Clearance of its Investigational New Drug Application using REYOBIQTM for the Treatment of Childhood Brain Cancer

June 25
Last Trade: 0.63 0.08 15.27

Phase 1/2a clinical trial currently supported by a $3.0 million grant from the U.S. Department of Defense Trial will enroll children with high grade glioma and ependymoma HOUSTON, June 25, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today...Read more


Cue Biopharma Receives FDA Feedback on Pre-IND Briefing Document Reinforcing Company’s Intention to Advance IND Submission for CUE-401 to Address Unmet Need in the Treatment of Autoimmune Disease

June 24
Last Trade: 0.83 0.04 4.56

CUE-401, a first-in-class bispecific molecule designed to induce and expand Tregs in vivo through the co-activity of transforming TGF-β and a modified variant of IL-2 BOSTON, June 24, 2025 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune...Read more


Syndax Pharmaceuticals Announces FDA Priority Review of sNDA for Revuforj® (revumenib) in Relapsed or Refractory mNPM1 Acute Myeloid Leukemia

June 24
Last Trade: 15.74 1.01 6.86

PDUFA action date set for October 25, 2025  sNDA being reviewed under FDA’s RTOR program  Revumenib has the potential to become the first and only menin inhibitor approved in both R/R mNPM1 AML and R/R KMT2Ar acute leukemia  NEW YORK, June 24, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced that the...Read more


GH Research Submits Complete IND Hold Response to FDA Ahead of Schedule

June 20
Last Trade: 12.79 0.01 0.08

DUBLIN, June 20, 2025 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today announced that, in June, it submitted its complete response to the previously announced clinical hold of its Investigational New Drug Application (IND) for GH001 to the U.S. Food and Drug Administration...Read more


Aldeyra Therapeutics Resubmits Reproxalap New Drug Application for the Treatment of Dry Eye Disease

June 17
Last Trade: 5.39 0.09 1.70

LEXINGTON, Mass. / Jun 17, 2025 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune‑mediated and metabolic diseases, today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, an investigational new drug candidate, for the treatment...Read more


Centessa Pharmaceuticals Announces Clearance of Investigational New Drug Application (IND) for ORX142, a Novel Orexin Receptor 2 (OX2R) Agonist; Clinical Data in Acutely Sleep-Deprived Healthy Volunteers Planned for this Year

June 16
Last Trade: 18.05 0.41 2.32

BOSTON and LONDON, June 16, 2025 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the IND to initiate a Phase 1 clinical study of ORX142 in healthy volunteers. ORX142 is an investigational, novel, highly potent and selective OX2R agonist being developed for the treatment of select neurological and...Read more


MBX Biosciences Announces IND Submission of MBX 4291, its Long-acting GLP1/GIP Receptor Co-agonist Prodrug for the Treatment of Obesity

June 16
Last Trade: 14.72 1.50 11.36

GLP-1/GIP receptor co-agonist designed to be highly potent and for once-monthly administration based on MBX’s novel PEP™ platform technology Phase 1 trial of MBX 4291 is expected to initiate in Q3 2025 CARMEL, Ind., June 16, 2025 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of...Read more


Ocugen Announces U.S. FDA Clearance of Investigational New Drug Amendment to Initiate Phase 2/3 Pivotal Confirmatory Clinical Trial of OCU410ST—Modifier Gene Therapy Candidate for Stargardt Disease

June 16
Last Trade: 1.05 0.02 1.94

MALVERN, Pa., June 16, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) amendment to initiate a Phase 2/3 pivotal confirmatory trial of OCU410ST, a modifier gene therapy candidate being developed for all Stargardt disease...Read more


Aquestive Therapeutics Announces FDA Acceptance of New Drug Application and PDUFA Date for Anaphylm™ for the Treatment of Severe Allergic Reactions

June 16
Last Trade: 4.11 0.00 0.00

FDA assigns PDUFA target action date of January 31, 2026 WARREN, N.J., June 16, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug...Read more


Innoviva: FDA Grants Priority Review for Zoliflodacin New Drug Application for the Treatment of Uncomplicated Gonorrhea and Assigns Target PDUFA Date of December 15, 2025

June 12
Last Trade: 20.92 0.04 0.19

FDA is expected to notify Innoviva Specialty Therapeutics regarding its decision to conduct an Advisory Committee Meeting in the Day 74 letter If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades WALTHAM, Mass. & GENEVA / Jun 12, 2025 / Business Wire / Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), in collaboration with the Global Antibiotic Research...Read more


Thiogenesis Therapeutics Announces FDA Clearance of its Investigational New Drug Application ("IND") for a Phase 2a Clinical Trial in Leigh Syndrome Spectrum

June 11
Last Trade: 0.78 0.00 0.00

San Diego, California--(Newsfile Corp. - June 11, 2025) - Thiogenesis Therapeutics, Corp. (TSXV: TTI) (OTCQX: TTIPF) ('Thiogenesis' or the 'Company') a clinical-stage biotechnology company developing disulfides that drive the production of intracellular cysteine, an amino acid that is a critical precursor to the generation of the master antioxidant glutathione and other important therapeutic compounds, today announced that the U.S. Food...Read more


Jazz Pharmaceuticals: Zepzelca® (lurbinectedin) and Atezolizumab (Tecentriq®) Combination Granted U.S. FDA Priority Review for First-Line Maintenance Treatment of Extensive-Stage Small Cell Lung Cancer

June 10
Last Trade: 117.77 1.10 0.94

Target Action (PDUFA) Date set for October 7, 2025 Application based on data from IMforte, the first Phase 3 trial demonstrating statistically significant and clinically meaningful improvements in both progression-free and overall survival in the ES-SCLC first-line maintenance setting Jazz to host investor webcast on Tuesday, June 10 at 4:30 p.m. EDT / 9:30 p.m. IST to review Zepzelca data For U.S. media and investors only DUBLIN,...Read more


Monte Rosa Therapeutics Announces FDA Clearance of IND Application for MRT-8102, a NEK7-Directed Molecular Glue Degrader for the Treatment of Multiple Inflammatory Diseases

June 10
Last Trade: 4.58 0.23 5.29

MRT-8102, a highly selective NEK7-directed molecular glue degrader (MGD) developed to treat inflammatory conditions linked to NLRP3, IL-1β, and IL-6 dysregulation, expands Monte Rosa’s clinical I&I portfolio Potency, selectivity, and long-lasting pharmacodynamics of MRT-8102 observed in preclinical studies create potential for clinical differentiation from competitive approaches for inflammatory diseases MRT-8102 Phase 1 clinical...Read more


Innoviva Specialty Therapeutics Receives FDA New Drug Application Acceptance for Zoliflodacin, a First-in-Class Oral Antibiotic for Uncomplicated Gonorrhea in Adults

June 10
Last Trade: 20.92 0.04 0.19

In laboratory studies, zoliflodacin has been shown to be active against Neisseria gonorrhoeae including multidrug-resistant strains. If approved, zoliflodacin could become the first new antibiotic treatment for gonorrhea in decades. WALTHAM, Mass. & GENEVA, Switzerland / Jun 10, 2025 / Business Wire / Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), in collaboration with the Global Antibiotic...Read more


Unicycive Therapeutics Provides Update on New Drug Application for Oxylanthanum Carbonate to Treat Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis

June 10
Last Trade: 4.70 0.07 1.51

The U.S. Food and Drug Administration (FDA) identified deficiencies at a third-party manufacturing vendor FDA to provide final decision by PDUFA action date of June 28, 2025 LOS ALTOS, Calif., June 10, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY or the “Company”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced an update on its New Drug...Read more


Axsome Therapeutics Provides Update on the New Drug Application (NDA) for AXS-14 for the Management of Fibromyalgia

June 9
Last Trade: 109.22 0.47 0.43

NEW YORK, June 09, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced it has received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for AXS-14 (esreboxetine) for the management of fibromyalgia. The FDA states that upon preliminary...Read more


Arvinas Announces Submission of New Drug Application to U.S. FDA for Vepdegestrant for Patients with ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer

June 6
Last Trade: 7.09 0.01 0.14

This submission is supported by the pivotal Phase 3 VERITAC-2 clinical trial, results of which were recently presented at the 2025 American Society for Clinical Oncology Annual Meeting and published in The New England Journal of Medicine VERITAC-2 data support vepdegestrant as a potential treatment option in patients with ESR1m ER+/HER2- advanced or metastatic breast cancer NEW HAVEN, Conn., June 06, 2025 (GLOBE NEWSWIRE) --...Read more


NRx Pharmaceuticals Files Abbreviated New Drug Application (ANDA) for Preservative-Free IV Ketamine

June 5
Last Trade: 2.89 0.22 8.24

Ketamine faces a current US drug shortage not expected to abate in the near future1 Current ketamine market estimated at $750 million and projected to reach $3.35 billion globally in 2034.2  NRx anticipates marketing ketamine for all approved uses Company anticipates priority review based on current and anticipated drug shortage NRX-100 to provide innovative, preservative-free IV ketamine formulation to eliminate...Read more


Ascendis Pharma: FDA Accepts TransCon® CNP NDA for Priority Review

June 2
Last Trade: 198.32 6.28 3.27

Once-weekly TransCon CNP demonstrated significantly higher annualized growth velocity, the primary endpoint, compared to placebo Multiple benefits beyond linear growth were observed compared to placebo, with a safety and tolerability profile similar to placebo The FDA grants Priority Review designation for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the...Read more


Erasca Announces IND Clearance for Potential First-in-Class and Best-in-Class Pan-KRAS Inhibitor ERAS-4001

June 2
Last Trade: 1.64 0.07 4.46

Both ERAS-4001 and potential best-in-class pan-RAS molecular glue ERAS-0015 received IND clearance in May ahead of company guidance Initial Phase 1 monotherapy data for both RAS-targeting programs expected in 2026 SAN DIEGO, June 02, 2025 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK...Read more


Kura Oncology and Kyowa Kirin Announce FDA Acceptance and Priority Review of New Drug Application for Ziftomenib in Adults with Relapsed or Refractory NPM1-Mutant AML

June 1
Last Trade: 7.41 0.81 12.27

New Drug Application based on positive results from the Phase 2 KOMET-001 trial FDA assigns a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2025 Potential first approval of a menin inhibitor for the treatment of adult patients with relapsed or refractory AML with an NPM1 mutation SAN DIEGO and TOKYO, June 01, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd....Read more


UroGen Pharma Announces Outcome of Oncologic Drugs Advisory Committee for UGN-102 for the Treatment of Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)

May 21
Last Trade: 19.71 -0.37 -1.84

PRINCETON, N.J. / May 21, 2025 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a leading biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, announced the outcome of today’s meeting of the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA), which discussed the new drug application (NDA) for investigational drug UGN-102...Read more


Travere Therapeutics Announces FDA Acceptance of sNDA for FILSPARI® (sparsentan) in FSGS

May 15
Last Trade: 18.82 0.59 3.24

PDUFA target action date of January 13, 2026 If approved, FILSPARI would be the first and only FDA-approved treatment for FSGS, a rare kidney condition and a leading cause of kidney failure SAN DIEGO / May 15, 2025 / Business Wire / Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for traditional approval of FILSPARI...Read more


BioCryst Pharmaceuticals Announces FDA Acceptance of NDA for ORLADEYO® (berotralstat) Oral Granules in Patients with Hereditary Angioedema Aged 2 to 11 Years

May 14
Last Trade: 8.37 -0.09 -1.06

FDA grants Priority Review of application, with PDUFA target action date of September 12, 2025 ORLADEYO would be the first targeted oral prophylactic therapy for patients with HAE under the age of 12, if approved RESEARCH TRIANGLE PARK, N.C., May 14, 2025 (GLOBE NEWSWIRE) --  BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application...Read more


UroGen Announces FDA Advisory Committee for UGN-102, an Investigational Treatment for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

May 7
Last Trade: 19.71 -0.37 -1.84

PRINCETON, N.J. / May 07, 2025 / Business Wire / UroGen (NASDAQ: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that the U.S. Food and Drug Administration (FDA) has scheduled an Oncologic Drugs Advisory Committee (ODAC) meeting on May 21, 2025 to review the new drug application (NDA) for UGN-102 (mitomycin) for intravesical solution, an...Read more


IDEAYA Biosciences Announces US FDA IND-Clearance for IDE849, a Potential First-in-Class DLL3 TOP1 ADC, for a Phase 1 Study in Solid Tumors

May 6
Last Trade: 24.33 -0.04 -0.16

Targeting to evaluate IDE849 (SHR-4849) in SCLC, NETs, and other DLL3-upregulated solid tumors, and in combination with IDE161/PARG to potentially enhance durability Targeting to present clinical data of over 40 SCLC patients, including the dose escalation and expansion, from partner Hengrui at medical conference in Q3 2025 SOUTH SAN FRANCISCO, Calif., May 6, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision...Read more


Lantern Pharma Advances Drug Candidate LP-184 with IND Clearance for Phase 1b/2 Clinical Trial in Triple Negative Breast Cancer (TNBC)

May 5
Last Trade: 4.57 0.00 0.00

The FDA has cleared the investigational new drug (IND) application of LP-184 in triple negative breast cancer (TNBC) treatment – a novel small molecule advanced and developed with Lantern’s AI platform, RADR® The phase 1b/2 clinical trial plans to evaluate LP-184 in recurrent TNBC patients as both monotherapy and in combination with olaparib. This achievement follows the FDA’s Orphan Drug Designation for LP-184 in TNBC in 2023 and FDA...Read more


Vanda Pharmaceuticals Announces Bysanti™ NDA Filing; FDA Decision Expected in Early 2026

May 5
Last Trade: 4.36 -0.07 -1.58

WASHINGTON, May 5, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) informed Vanda that the New Drug Application (NDA) for Bysanti™ (milsaperidone) has been filed, and that at this time no potential review issues have been identified. The FDA has set February 21, 2026 as the target date for decision on this application. Bysanti™ is a new chemical...Read more


Delcath Systems Announces FDA Clearance of IND Application for Phase 2 Clinical Trial of HEPZATO™ in Liver-Dominant Metastatic Breast Cancer

April 28
Last Trade: 10.36 -0.11 -1.05

QUEENSBURY, N.Y. / Apr 28, 2025 / Business Wire / Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced that the U.S. Food and Drug Administration (FDA) has completed its 30-day review of the Company's Investigational New Drug (IND) application for a Phase 2 clinical trial evaluating HEPZATO™ in combination with standard of care (SOC) for...Read more


Eton Pharmaceuticals Announces Submission of NDA for ET-600 (Desmopressin Oral Solution)

April 28
Last Trade: 17.04 0.31 1.85

NDA submitted for the treatment of central diabetes insipidus Expected 10-month review; commercial preparations underway for a potential Q1 2026 launch  DEER PARK, Ill., April 28, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the submission of a New Drug...Read more


Verastem Oncology Announces U.S. IND Clearance of VS-7375, Oral KRAS G12D (ON/OFF) Inhibitor, Enabling Phase 1/2a Trial in Advanced Solid Tumors

April 23
Last Trade: 8.22 0.49 6.34

Expect to initiate a Phase 1/2a trial in the U.S. in advanced KRAS G12D mutant solid tumors in mid-2025 Initial safety and efficacy results from the trial of VS-7375 by partner GenFleet Therapeutics to be presented at the 2025 ASCO Annual Meeting BOSTON / Apr 23, 2025 / Business Wire / Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers,...Read more


Zai Lab Announces Acceptance of Supplemental New Drug Application for Repotrectinib for Patients with NTRK-Positive Solid Tumors

April 21
Last Trade: 35.73 0.80 2.29

SHANGHAI & CAMBRIDGE, Mass. / Apr 21, 2025 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the supplemental New Drug Application (sNDA) for repotrectinib for the treatment of adult patients with solid tumors that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. The application is intended for patients whose disease is...Read more


Calidi Biotherapeutics Announces FDA Clearance of IND Application for CLD-201 in Solid Tumors

April 17
Last Trade: 5.30 0.26 5.16

SAN DIEGO, April 17, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company pioneering targeted antitumor virotherapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLD-201. This investigational, allogeneic stem cell-based immunotherapy is set to advance into clinical development for...Read more


Nurix Therapeutics Announces FDA Clearance of IND Application for GS-6791/NX-0479 - a Novel IRAK4 Degrader for Inflammatory Conditions

April 17
Last Trade: 10.58 0.02 0.19

Collaboration partner, Gilead Sciences, to begin Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study in healthy volunteers in Q2 2025 GS-6791/NX-0479 has potential clinical applications across multiple blockbuster markets in inflammation, in both rheumatology and dermatology, including rheumatoid arthritis and atopic dermatitis Nurix to receive a $5 million milestone payment from Gilead for FDA clearance of the...Read more


Kura Oncology and Kyowa Kirin Announce Submission of New Drug Application for Ziftomenib to FDA

April 8
Last Trade: 7.41 0.81 12.27

SAN DIEGO and TOKYO, April 08, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”), and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”), today announced Kura submitted a New Drug Application (NDA) for ziftomenib, a highly selective, once-daily, oral, investigational menin inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM 1) mutation to...Read more


ALX Oncology Receives IND Clearance from U.S. FDA for ALX2004, a Novel EGFR-targeted Antibody-drug Conjugate

April 7
Last Trade: 0.64 -0.01 -1.68

ALX2004 is a potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors that was created from ALX Oncology’s proprietary linker-payload platform ALX2004, the company’s first ADC, was fully designed and developed in-house by ALX Oncology scientists Company expects to initiate Phase 1 clinical trials of ALX2004 in mid-2025, with initial safety data available in 1H 2026 SOUTH SAN...Read more


CureVac Receives U.S. FDA IND Clearance to Initiate Phase 1 Clinical Trial for Novel mRNA-Based Precision Immunotherapy in Squamous Non-Small Cell Lung Cancer

April 7
Last Trade: 5.48 -0.03 -0.54

Significant Regulatory Milestone: U.S. FDA cleared IND application for CVHNLC, CureVac's investigational therapy targeting squamous non-small cell lung cancer Proprietary Epitopes: CVHNLC encodes novel tumor epitopes identified through proprietary whole genome-based discovery platform Enhanced Combination Therapy: CVHNLC to be tested in combination with pembrolizumab, aiming to amplify targeted anti-tumor immune...Read more


Apellis Pharmaceuticals Announces FDA Acceptance and Priority Review of the Supplemental New Drug Application for EMPAVELI® (pegcetacoplan) for C3G and Primary IC-MPGN

April 1
Last Trade: 27.75 0.13 0.47

PDUFA target action date is July 28, 2025 WALTHAM, Mass., April 01, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation of the supplemental New Drug Application (sNDA) for EMPAVELI® (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis...Read more


Ascendis Pharma Submits U.S. NDA for TransCon CNP (Navepegritide) for the Treatment of Children with Achondroplasia

March 31
Last Trade: 198.32 6.28 3.27

Data demonstrated multiple clinical benefits beyond linear growth NDA supported by data from three randomized, double-blind, placebo-controlled clinical trials in children with achondroplasia, with up to three years of open-label extension data MAA in EU on track for submission during Q3 2025 COPENHAGEN, Denmark, March 31, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that it has submitted its New...Read more


Vanda Pharmaceuticals Announces the Submission of an NDA to the FDA for Bysanti™ for the Treatments of Acute Bipolar I Disorder and Schizophrenia

March 31
Last Trade: 4.36 -0.07 -1.58

WASHINGTON, March 31, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) requesting marketing approval of Bysanti™ (milsaperidone) for the treatments of acute bipolar I disorder and schizophrenia. The NDA is supported by several clinical studies assessing the efficacy and safety of Bysanti™. Bysanti™ is a new...Read more


Liquidia Announces FDA Acceptance of New Drug Application Resubmission for YUTREPIA™ (treprostinil) Inhalation Powder

March 28
Last Trade: 25.95 -0.14 -0.54

MORRISVILLE, N.C., March 28, 2025 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) resubmission for YUTREPIA™ (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension...Read more


Beam Therapeutics Announces Clearance of Investigational New Drug Application for BEAM-302 for the Treatment of Alpha-1 Antitrypsin Deficiency (AATD) by the United States (U.S.) Food and Drug Administration

March 27
Last Trade: 17.82 0.19 1.08

U.S. IND Represents Regulatory Clearance For BEAM-302 Spanning Six Countries and Second Open IND for a Beam In Vivo Base Editing Program in the U.S. CAMBRIDGE, Mass., March 27, 2025 (GLOBE NEWSWIRE) -- Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced that the United States (U.S.) Food and Drug Administration (FDA) has cleared the...Read more


Verve Therapeutics Announces Clearance of Investigational New Drug Application by the U.S. FDA for VERVE-102, an Investigational Gene Editing Medicine Designed to Durably Lower Cholesterol After a Single Dose

March 24
Last Trade: 11.26 0.00 0.00

BOSTON, March 24, 2025 (GLOBE NEWSWIRE) -- Verve Therapeutics, a clinical-stage company developing a new class of genetic medicines for cardiovascular disease, today announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for VERVE-102 for the treatment of patients living with heterozygous familial hypercholesterolemia (HeFH) and/or premature coronary artery disease (CAD)....Read more


Telix Pharmaceuticals: FDA Approves New Prostate Cancer Imaging Agent Gozellix®

March 21
Last Trade: 11.54 0.55 5.00

MELBOURNE, Australia and INDIANAPOLIS, March 21, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Gozellix® (TLX007-CDx, kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s next-generation PSMA-PET imaging1 agent for prostate...Read more


Scienture announces the U.S. FDA Approval of its NDA for SCN-102, to be launched as ArbliTM, (losartan potassium) Oral Suspension, 10mg/mL. The global market for losartan potassium was approximately $1.5 billion in sales in 2024.

March 18
Last Trade: 1.21 0.00 0.00

TAMPA, FL, March 18, 2025 (GLOBE NEWSWIRE) -- – SCIENTURE HOLDINGS, INC. NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through developing, bringing to market, and distributing novel specialty products to satisfy unmet market needs, is pleased to announce the U.S. Food and Drug Administration (FDA) has approved...Read more


Xeris Biopharma Announces Approval of Supplemental New Drug Application (sNDA) of Gvoke VialDx™ (glucagon) for Use as a Diagnostic Aid

March 17
Last Trade: 7.68 0.39 5.35

First concentrated, ready-to-dilute liquid glucagon available for growing procedural gastroenterology market American Regent to commercialize GVOKE VialDx™ Availability is expected in the third quarter of 2025 CHICAGO / Mar 17, 2025 / Business Wire / Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products...Read more


Precision BioSciences Announces Clearance of Investigational New Drug Application by the U.S. FDA for First-in-Class PBGENE-HBV Designed to Eliminate Root Cause of Chronic Hepatitis B

March 17
Last Trade: 4.71 -0.06 -1.26

PBGENE-HBV is the first-ever investigational in vivo gene editing therapy cleared to enter clinical trials for the treatment of chronic hepatitis B in the United States (U.S.)  IND clearance represents a significant regulatory milestone for PBGENE-HBV  Company to expand its Phase 1 ELIMINATE-B study to the U.S., joining world-class clinical sites in Moldova, Hong Kong, and New Zealand where strong clinical execution is...Read more


Travere Therapeutics Submits sNDA to FDA for Approval of FILSPARI® (sparsentan) for the Treatment of FSGS

March 17
Last Trade: 18.82 0.59 3.24

sNDA submission based on results from Phase 3 DUPLEX and Phase 2 DUET studies of FILSPARI in FSGS If approved, FILSPARI could become the first and only FDA-approved treatment for FSGS, a rare kidney condition and a leading cause of kidney failure Additionally, the FDA notified the Company that REMS monitoring for embryo-fetal toxicity is no longer necessary; the Company plans to submit an amendment to the REMS sNDA currently under...Read more


PDS Biotechnology Announces FDA Clearance of IND Application for Combination of Versamune® MUC1 and PDS01ADC to Treat Metastatic Colorectal Cancer

March 13
Last Trade: 1.19 -0.01 -0.83

Phase 1/2 trial evaluating the proprietary combination to be run under CRADA with the National Cancer Institute Second Versamune® platform candidate targets MUC1-positive solid tumors U.S. Patent #12,201,685 covering methods of using combinations of the Versamune® platform and various immunocytokines, including PDS01ADC recently issued PRINCETON, N.J., March 13, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB)...Read more


Sagimet Biosciences Announces Clearance of IND for FASN Inhibitor TVB-3567, to be Developed for the Treatment of Acne

March 11
Last Trade: 7.67 -1.00 -11.53

TVB-3567 is the Company’s second fatty acid synthase (FASN) inhibitor First-in-human Phase 1 trial initiation planned in 2025 SAN MATEO, Calif., March 11, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced the clearance of its Investigational New Drug (IND)...Read more


scPharmaceuticals Announces FDA Approval of Supplemental New Drug Application Expanding the FUROSCIX® Indication to Include the Treatment of Edema in Patients with Chronic Kidney Disease

March 6
Last Trade: 4.60 -0.35 -7.07

FDA approves scPharmaceuticals’ supplemental New Drug Application to expand the FUROSCIX indication to include the treatment of edema in adult patients with chronic kidney disease, including nephrotic syndrome FUROSCIX is expected to be available for chronic kidney disease patients in April 2025 BURLINGTON, Mass., March 06, 2025 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company...Read more


Tiziana Life Sciences Files Investigational New Drug Application with FDA for ALS Phase 2 Clinical Trial

March 4
Last Trade: 1.97 -0.03 -1.50

NEW YORK, March 04, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced the submission of its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a phase 2...Read more


FDA Files Corcept’s New Drug Application for Relacorilant as Treatment for Patients With Hypercortisolism

March 3
Last Trade: 71.75 -0.25 -0.35

FDA assigns a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025 REDWOOD CITY, Calif. / Mar 03, 2025 / Business Wire / Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that the U.S....Read more


Sernova Biotherapeutics Receives FDA Clearance for IND Application for its Cell Pouch Bio-hybrid Organ with Autograft Thyroid Cells in Patients with Hypothyroidism

March 3
Last Trade: 0.20 0.005 2.56

LONDON, Ontario and BOSTON, March 03, 2025 (GLOBE NEWSWIRE) -- Sernova Biotherapeutics, (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a leading regenerative medicine company focused on developing it’s Cell Pouch bio-hybrid organ as a functional cure for type 1 diabetes, today announced that the U.S. Food and Drug Administration (FDA) has cleared it’s Investigational New Drug (IND) application to evaluate the Company’s Cell Pouch with...Read more


PharmaTher Provides Complete Response Amendment for US FDA New Drug Application for Ketamine

March 3
Last Trade: 0.43 -0.02 -4.44

Expecting FDA approval of Ketamine in Q2-2025 Solving the shortage problem of Ketamine and unlocking its pharmaceutical potential Toronto, Ontario--(Newsfile Corp. - March 3, 2025) - PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) (the "Company" or "PharmaTher"), a specialty pharmaceutical company, is pleased to announce today that the Company has provided its resubmission to the complete response amendment for its U.S. Food and...Read more


BioRestorative Therapies Announces FDA Clearance of IND for Phase 2 Trial of BRTX-100 in Chronic Cervical Discogenic Pain

February 27
Last Trade: 1.52 0.05 3.40

BRTX-100 is the first and only stem cell product candidate cleared to be evaluated in the cervical degenerative disc disease setting IND clearance expands Company’s advanced clinical pipeline for BRTX-100 treatment of both chronic lower back and neck pain Company to host webcasted conference call today at 10:30am EST MELVILLE, N.Y., Feb. 27, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the...Read more


Arcutis Biotherapeutics: U.S. FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis 

February 26
Last Trade: 16.89 0.91 5.69

U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of October 13, 2025  Application supported by positive efficacy and safety data from pivotal Phase 3 trial, pivotal long-term extension study, and Phase 1 pharmacokinetic study  If approved, ZORYVE cream 0.05% will be a new topical therapy option for approximately 1.8 million children aged 2 to 5 with atopic dermatitis...Read more


Teva Pharmaceutical and Medincell Announce FDA Acceptance of Supplemental New Drug Application for UZEDY(R) (risperidone) Extended-Release Injectable Suspension as a Treatment for Patients with Bipolar I Disorder

February 25
Last Trade: 17.86 0.32 1.82

UZEDY is currently approved in the US as a subcutaneous long-acting injectable (LAI) for use every one or two months for the treatment of schizophrenia in adults1 LAI treatment options may help address unmet needs of people living with bipolar I disorder (BP-I) BP-I filing acceptance for UZEDY represents Teva’s commitment to pursuing new advances in neuroscience PARSIPPANY, N.J. and TEL AVIV, Israel and PARIS, Feb. 25, 2025 (GLOBE...Read more


Glaukos Announces FDA Acceptance of NDA Submission for Epioxa™

February 24
Last Trade: 89.86 -1.22 -1.34

PDUFA Date Set for October 20, 2025 ALISO VIEJO, Calif. / Feb 24, 2025 / Business Wire / Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced it has received the “Day 74” notification from the U.S. Food and Drug Administration (FDA) acknowledging the previously submitted New Drug...Read more


Amneal Pharmaceuticals Launches Mesalamine and Receives U.S. FDA Approval for Lenalidomide

February 19
Last Trade: 9.45 0.06 0.64

Mesalamine 800 mg delayed-release tablets, referencing ASACOL HD® Lenalidomide capsules, referencing REVLIMID® BRIDGEWATER, N.J. / Feb 19, 2025 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, today announced the launch of mesalamine 800 mg delayed-release tablets, an aminosalicylate indicated for the treatment of moderately active ulcerative colitis in...Read more


PTC Therapeutics Announces FDA Acceptance and Priority Review for Vatiquinone NDA for the Treatment of Children and Adults with Friedreich's Ataxia

February 19
Last Trade: 48.82 0.12 0.25

PDUFA target action date of Aug. 19, 2025  WARREN, N.J., Feb. 19, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for vatiquinone for the treatment of children and adults living with Friedreich's ataxia (FA). The application has been granted Priority Review and assigned a Prescription Drug User...Read more


U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review

February 18
Last Trade: 118.37 -0.65 -0.55

If Approved, Lenacapavir Would Be the First and Only Twice-Yearly HIV Prevention Choice  FDA to Review Applications Under Priority Review, with a PDUFA Date of June 19, 2025  Gilead Also Recently Submitted Applications for Lenacapavir for PrEP to the European Medicines Agency That Will Be Reviewed Under Accelerated Assessment Review Timeline  FOSTER CITY, Calif. / Feb 18, 2025 / Business Wire / Gilead Sciences, Inc....Read more


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