Kennewick, WA, July 14, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), a pioneer in Precision Radionuclide TherapyTM (PRnT) solutions, today announced the submission of its Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) for RadioGel®, a novel hydrogel-based radioactive therapy designed to deliver targeted radiation to solid tumors. This comprehensive submission, supported by extensive...Read more
Atara Biotherapeutics Resubmits Tabelecleucel (Tab-cel®) Biologics License Application for Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease to the U.S. FDA Approval of BLA Would Trigger $40 Million Milestone Payment from Pierre Fabre Laboratories THOUSAND OAKS, Calif. / Jul 14, 2025 / Business Wire / Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel...Read more
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
Complete Response Letter (CRL) cited specific chemistry, manufacturing and controls (CMC) related observations that are resolvable FDA clinical reviews acknowledged that the clinical data are robust and biomarker data are supportive NOVATO, Calif., July 11, 2025 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response...Read more
FDA issued Complete Response Letter Capricor plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial in Q3 2025 to continue pursuing the indication for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy FDA advised Capricor to request a meeting to determine next steps toward potential approval Conference call and webcast scheduled for today at 8:30 a.m. ET SAN DIEGO, July 11, 2025...Read more
New PDUFA Action Date of December 13, 2025 $75 Million Royalty Purchase Agreement Payment from RTW Extended Through 2025 MONTREAL and CHARLOTTE, N.C., July 11, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) (Milestone) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Milestone’s response to issues raised in the Complete Response Letter (CRL) for CARDAMYST™...Read more
12-Month Parasiticide Treatment for Dogs Offers Unrivaled Duration of Flea and Tick Protection Compared to Existing Products RAHWAY, N.J. / Jul 10, 2025 / Business Wire / Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced the U.S. Food and Drug Administration (FDA) approval of BRAVECTO® QUANTUM (fluralaner for...Read more
Intuitive’s latest advanced energy instrument features a unique curved tip for enhanced precision SUNNYVALE, Calif., July 10, 2025 (GLOBE NEWSWIRE) -- Intuitive (Nasdaq: ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, today announced that the U.S. Food & Drug Administration (FDA) has cleared its latest innovation in advanced energy instrumentation for use with its...Read more
PRISM-1, the ongoing registrational, Phase 3 study evaluating quemliclustat plus chemotherapy as a first-line treatment for metastatic pancreatic cancer, is expected to be fully enrolled by the end of this year. HAYWARD, Calif. / Jul 10, 2025 / Business Wire / Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with...Read more
Positive Discussion on Path Forward for Registrational Program PURCHASE, N.Y., July 10, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, conducted an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on July 9, 2025. The objective of this meeting was to review results from the Phase 2...Read more
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
The newly recommended dosing schedule significantly lowered ARIA-E rates compared to the original dosing schedule, adding to the established safety profile of the treatment INDIANAPOLIS, July 9, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved a label update with a new recommended titration dosing schedule for Kisunla (donanemab-azbt), Lilly's...Read more
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
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
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
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
In an ongoing Phase 1 trial published in Nature Medicine, MB-101 was well-tolerated and 50% of patients achieved stable disease or better with two partial responses and two complete responses lasting 7.5 and 66+ months, respectively Preclinical data support a novel combination of MB-101 (IL13Rα2‐targeted CAR-T cell therapy) and MB-108 (HSV-1 oncolytic virus) to optimize clinical results FDA previously granted Orphan Drug Designation...Read more
Fourth and final module of the PMA submitted in June Supportive analyses included in final module of the PMA meet both of the pre-specified co-primary endpoints in the AUDACITY Study NATICK, Mass. / Jul 07, 2025 / Business Wire / Allurion Technologies, Inc. (NYSE: ALUR), a pioneer in metabolically healthy weight loss, today announced submission of the fourth and final module of the Pre-Market Approval (PMA) application to the Food...Read more
FDA assigns PDUFA target action date of January 5, 2026, for decision on accelerated approval Tividenofusp alfa is designed to deliver missing enzyme to entire body and cross blood-brain barrier into the brain Tividenofusp alfa leads company’s broader TransportVehicle™-enabled pipeline SOUTH SAN FRANCISCO, Calif., July 07, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that the U.S. Food and Drug...Read more
The clinical trial at the University of Washington will study Filament's botanical psilocybin drug candidate, PEX010 VANCOUVER, BC, July 7, 2025 /CNW/ - Filament Health Corp. (OTC:FLHLF) ("Filament" or the "Company"), a clinical-stage natural psychedelic drug development company, today announced that the U.S. Food and Drug Administration (FDA) has authorized a phase 2 clinical trial studying the Company's botanical psilocybin...Read more
The FARAPULSE PFA System now approved for pulmonary vein and posterior wall ablation in patients with persistent atrial fibrillation MARLBOROUGH, Mass., July 7, 2025 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval to expand the instructions for use (IFU) labeling for the FARAPULSE™ Pulsed Field Ablation (PFA) System. The updated labeling now includes approval for...Read more
Breakthrough Therapy designation based on interim clinical data from Phase I/II trials showing clinically meaningful improvements in cardiac biomarkers and functional measures LX2006 also selected for FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) program, created to facilitate CMC registrational readiness and support faster patient access NEW YORK, July 07, 2025 (GLOBE NEWSWIRE) -- Lexeo...Read more
First new on-demand HAE treatment in over a decade, with potential to transform management of the disease Data demonstrated rapid symptom relief and attack resolution regardless of attack severity, location, age, or use of long-term prophylaxis, and well-established safety profile Management to host conference call today at 8:30 a.m. ET CAMBRIDGE, Mass. & SALISBURY, England / Jul 07, 2025 / Business Wire / KalVista...Read more
Company will be seeking alignment to begin rolling BLA submission NEW YORK / Jul 03, 2025 / Business Wire / OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced it was granted an End of Phase 2 Meeting by the United States Food & Drug Administration (“FDA”) to review the OST-HER2 program in the prevention or delay...Read more
TARRYTOWN, N.Y., July 02, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an...Read more
PRINCETON, N.J., July 2, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in blood purification therapies for life-threatening conditions in the intensive care unit and cardiac surgery, today provided a regulatory update on its marketing applications for DrugSorb™-ATR with the U.S. Food and Drug Administration (FDA) and Health Canada. DrugSorb-ATR is an FDA-designated Breakthrough Device designed to...Read more
RAHWAY, N.J. / Jul 02, 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 Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking approval to update the U.S. product label based on the Phase 3 ZENITH trial for WINREVAIR™ (sotatercept-csrk). In 2024, WINREVAIR was approved for the...Read more
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
NEW YORK, June 30, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced alignment with the United States Food and Drug Administration (FDA) on items required for filing a Biologics License Application (BLA) for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic heart failure with reduced ejection fraction (HFrEF) and...Read more
GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with Less Than or Equal to 2 µg/mL IgA in a 10% Solution is Approved for Intravenous or Subcutaneous Use in People Aged Two and Older with Primary Immunodeficiency1 U.S. Commercialization of GAMMAGARD LIQUID ERC Projected to Begin in 2026 Company Announces Future Manufacturing Discontinuation End Date for Takeda's First-Generation Low-IgA Product, A Freeze-Dried Formulation in...Read more
FDA provides supportive feedback on proposed statistical analysis plan for neurofilament biomarker analysis of Clene’s NIH-sponsored Expanded Access Program NfL EAP biomarker analyses to be conducted early in the 4th Quarter of 2025 Clene confirms two additional FDA meetings scheduled for 3rd Quarter of 2025, to discuss ALS survival data and MS clinical development program Submission of new drug application for ALS under the...Read more
Complete Response Letter (CRL) cited deficiencies previously identified at a third-party manufacturing vendor unrelated to Oxylanthanum Carbonate (OLC) No other concerns stated, including pre-clinical, clinical, or safety data The Company identified a second manufacturing vendor that has already produced OLC drug product, which could also be used to support the resolution of the Clinical Manufacturing and Controls (CMC) issues...Read more
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
SKINVIVE by JUVÉDERM® is currently approved in the U.S. as the first and only hyaluronic acid microdroplet injectable indicated to improve cheek skin smoothness. If approved, SKINVIVE by JUVÉDERM® will be the first hyaluronic acid injectable treatment option aiming to reduce neck lines. The application for indication expansion is supported by a clinical study that met all primary and secondary endpoints assessing SKINVIVE...Read more
Demonstrates the potential of SGR-1505 as a novel approach for diseases with high unmet medical need NEW YORK / Jun 27, 2025 / Business Wire / Schrödinger, Inc. (Nasdaq: SDGR) today announced that SGR-1505, its clinical stage MALT1 inhibitor, was designated as a Fast Track product by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Waldenström macroglobulinemia that have failed at least two lines of...Read more
Phase 3 Aspire study enrollment on track to complete in 2025 Aurora study to evaluate GTX-102 in other Angelman syndrome genotypes and ages expected to initiate later this year NOVATO, Calif., June 27, 2025 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), today announced that it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for GTX-102 (apazunersen) as a treatment...Read more
Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access Only about 2 in 10 eligible patients currently receive cell therapy treatment; today’s announcement will reduce unnecessary barriers for patients and providers PRINCETON, N.J. / Jun 26, 2025 / Business Wire /...Read more
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
LEXINGTON, Mass. / Jun 26, 2025 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced receipt of a Special Protocol Assessment Agreement Letter from the U.S. Food and Drug Administration (FDA) for ADX-2191 (methotrexate injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma (PVRL), a rare and potentially fatal cancer currently lacking FDA-approved...Read more
Streamlining total ankle replacement with data-driven implants and surgical flexibility PORTAGE, Mich. / Jun 25, 2025 / Business Wire / Stryker (NYSE:SYK), a global leader in medical technologies, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Incompass® Total Ankle System, an implant intended for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative...Read more
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
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
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
DURHAM, N.C. / Jun 25, 2025 / Business Wire / Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for diseases with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation for PBGENE-DMD for the treatment of Duchenne muscular dystrophy (DMD). “The...Read more
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
MIAMI, June 24, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (the “Company”) (Nasdaq: NSPR), developer of the CGuard Prime Carotid Stent System for the prevention of stroke, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket application (PMA) approval of the CGuard Prime Carotid Stent System in the United States. The PMA approval is backed by best-in-class evidence from the Company’s C-GUARDIANS pivotal...Read more
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
The FDA has approved an updated label for Vizamyl (flutemetamol F 18 injection), including quantification which enables a more continuous and objective measure of amyloid in the brain This approval also enables clinicians to use Vizamyl to monitor patient response to anti-amyloid therapies Other updates include now enabling the use of Vizamyl to predict development of dementia or other cognitive decline due to Alzheimer’s disease,...Read more
With this approval, pediatric patients aged five years and older with active lupus nephritis will have a first-of-its-kind treatment option for at-home administration. PHILADELPHIA / Jun 24, 2025 / Business Wire / GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a 200 mg/mL autoinjector of Benlysta (belimumab), a B-lymphocyte stimulator (BlyS)-specific inhibiting monoclonal antibody,...Read more
ASHBURN, Va., June 24, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (“Quoin” or the “Company”), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) Designation for the Company’s lead asset, QRX003, for the treatment of Netherton Syndrome. The designation reinforces the...Read more
Company has requested End of Phase 2 Meeting and Breakthrough Therapy Designation (BTD) based upon the positive FDA Meeting feedback NEW YORK / Jun 24, 2025 / Business Wire / OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that it received positive written feedback from the US Food & Drug Administration (“FDA”)...Read more
Based on TROPION-Lung05 results and supported by data from TROPION-Lung01 First and only TROP2-directed therapy approved in the US for the treatment of lung cancer WILMINGTON, Del. / Jun 24, 2025 / Business Wire / DATROWAY® (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior...Read more
Breakthrough Therapy Designation based on promising early clinical evidence observed with daraxonrasib in patients with pancreatic ductal adenocarcinoma (PDAC) RASolute 302, a Phase 3 registrational study of daraxonrasib in patients with previously treated metastatic PDAC, expected to substantially complete enrollment this year REDWOOD CITY, Calif., June 23, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a...Read more
MELBOURNE, Australia and INDIANAPOLIS, June 23, 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 a label expansion for Illuccix® (kit for the preparation of gallium Ga-68 gozetotide, for injection) to include patient selection for radioligand therapy (RLT) in the pre-taxane setting. The...Read more
Interactions with FDA over the past year have provided clear expectations for the path to submission of the nomlabofusp BLA Written FDA recommendations for safety database include a total of at least 30 participants with continuous exposure for 6 months including a subset of at least 10 with 1-year; large majority of the exposure should be on the 50 mg dose BLA submission seeking accelerated approval planned in the second quarter of...Read more
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
Approval based on pivotal results showing improvements in sustained disease remission and reductions in itch and oral corticosteroid use compared to placebo in adults with BP BP is a chronic, debilitating and relapsing rare skin disease affecting approximately 27,000 adults in the U.S. whose disease is uncontrolled by systemic corticosteroids Dupixent is now approved in the U.S. to treat eight distinct diseases with underlying type 2...Read more
GENEVA, SWITZERLAND / ACCESS Newswire / June 20, 2025 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY ) (Relief or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced that its initial request for Qualified Infectious Disease Product (QIDP) designation for RLF-TD011 for the treatment of epidermolysis bullosa (EB)...Read more
Monjuvi® (tafasitamab-cxix) in combination with rituximab and lenalidomide is the first FDA-approved CD19- and CD20-targeted immunotherapy combination for adult patients with follicular lymphoma (FL) Patients with relapsed or refractory FL achieved significantly improved progression-free survival with Monjuvi in combination with rituximab and lenalidomide in the Phase 3 registration trial This milestone represents the second approved...Read more
Approval Based on Phase 3 PURPOSE 1 and PURPOSE 2 Data that Showed ≥99.9% of Participants Remained HIV Negative on Twice-Yearly Injectable Yeztugo Yeztugo, Nearly 20 Years in the Making, Represents a Major Breakthrough in the Fight Against HIV FOSTER CITY, Calif. / Jun 18, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo® (lenacapavir)—the...Read more
FDA priority review and approval based on interim results sets a positive precedent, paving the path for future Multikine approval Multikine reduced the risk of death by 66% compared to standard of care in the target population of patients with low and zero PD-L1, while Keytruda reduced the risk of recurrence and progression (EFS) by 30% compared with standard of care in patients whose tumors expressed higher PD-L1 without demonstrating...Read more
Annamycin aims to eliminate cardiotoxicity associated with anthracyclines used to treat about 60% of all children with cancer FDA recommends inclusion of patients as young as 6 months – younger than Moleculin had proposed – to be allowed in the pediatric clinical study Enrollment and dosing are ongoing in pivotal, adaptive design Phase 3 MIRACLE trial of Annamycin in adult patients with R/R AML; Initial data readout is on track...Read more
Ongoing progress in Phase 1 clinical trial of SENTI-202 for the treatment of Acute Myeloid Leukemia (AML) 20,800 newly diagnosed AML patients in the U.S. every year1 with 60% of patients experiencing relapse or death within 12 months2 Management releases Virtual Investor “What This Means” segment; Access here SOUTH SAN FRANCISCO, Calif., June 18, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio” or the...Read more
U.S. FDA grants Orphan Drug Designation to Deramiocel for the treatment of Becker Muscular Dystrophy, broadening Capricor’s focus in neuromuscular diseases Capricor remains on track for the August 31, 2025, PDUFA date for Deramiocel in Duchenne Muscular Dystrophy following successful FDA Pre-License Inspection SAN DIEGO, June 17, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing...Read more
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
Based on Type C meeting and new data, Dyne submitted revised ACHIEVE trial protocol to FDA elevating vHOT to primary endpoint for U.S. Accelerated Approval New positive clinical data from Phase 1/2 ACHIEVE trial support vHOT as early indicator of clinical benefit with DYNE-101 in DM1 Ongoing Registrational Expansion Cohort in ACHIEVE trial to enroll 60 participants and include sites in U.S. Company to host an...Read more
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
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
MONTREAL and CHARLOTTE, N.C., June 16, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced submission of its response to the U.S. Food and Drug Administration (FDA)’s Complete Response Letter (CRL) regarding its New Drug Application (NDA) for CARDAMYST™ (etripamil) nasal spray, a prescription medication in development for the conversion of acute episodes of paroxysmal supraventricular tachycardia...Read more
LungFit PH II’s smaller, lightweight, transport-ready design is expected to open the entirety of the NO market Final design based upon substantial feedback from respiratory therapists across the country GARDEN CITY, N.Y., June 16, 2025 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR) (“Beyond Air” or the “Company”), a commercial stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide...Read more
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
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
Approval introduces the first perioperative anti-PD-1 treatment regimen for adults with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 (CPS ≥1) RAHWAY, N.J. / Jun 13, 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 Administration (FDA) has approved KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1...Read more
FDA states heavy workload and limited resources prevent meeting PDUFA goal date of June 17 Agency indicates anticipated decision within four weeks CAMBRIDGE, Mass. & SALISBURY, England / Jun 13, 2025 / Business Wire / KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it will not meet the PDUFA goal date for the New Drug Application (NDA) for...Read more
Expanded indication builds on existing U.S. FDA approval of mRESVIA for adults aged 60 and older CAMBRIDGE, MA / ACCESS Newswire / June 12, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA® (mRNA-1345), the Company's respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18-59 years of...Read more
ZUSDURI (formerly known as UGN-102) is a localized medication designed for potent tumor ablation delivered by innovative RTGel® technology. Approval supported by pivotal Phase 3 ENVISION trial demonstrating 78% of patients achieved complete response (CR) at 3 months, and 79% of those responders maintained complete response at 12 months after the 3-month visit (DOR). Manageable safety profile characterized primarily by mild to moderate...Read more
Key complex product approval in the Affordable Medicines segment this year Commercial launch planned for third quarter of 2025 BRIDGEWATER, N.J., June 12, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of prednisolone acetate ophthalmic suspension, 1% sterile which references Pred Forte®. Pred Forte and its design are trademarks...Read more
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
NEW YORK, June 11, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on continued momentum with United States Food and Drug Administration (FDA) regarding both accelerated approval pathway for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and...Read more
Approval follows Priority Review and is supported by the robust TRUST clinical program, in which IBTROZI treatment demonstrated high, durable response rates and brain-penetrant efficacy across different lines of therapy The safety and tolerability of IBTROZI have been well established in the pivotal program, with one of the largest safety datasets in ROS1+ NSCLC showing a favorable and consistent profile Company to host conference call...Read more
MAVYRET® (glecaprevir/pibrentasvir) is the first and only oral eight-week pangenotypic treatment option approved for people with acute or chronic hepatitis C virus (HCV)* With this approval, providers can now treat HCV patients immediately at the time of diagnosis HCV is a curable condition, but patients can often go undiagnosed.1 If left untreated, people with acute HCV could progress to chronic disease, including liver-related...Read more
U.S. FDA successfully completed Pre-License Inspection; Company expects facility will meet all requirements to support licensure Advisory Committee meeting scheduled for July 30, 2025 Mid-cycle meeting recently completed with no significant issues or major deficiencies; late-cycle meeting planned for mid-July Biologics License Application remains under priority review with PDUFA target action date of August 31, 2025 SAN DIEGO,...Read more
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
Achieves FDA Alignment on CMC and Non-Clinical Toxicology Regulatory Path for Nebokitug in PSC Preparations for the Nebokitug PSC Phase 3 Clinical Trial Advance as Discussions with Potential Strategic Partners Continue TEL AVIV, Israel, June 11, 2025 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd., (Nasdaq: CMMB), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet...Read more
WILMETTE, Ill. and HOUSTON, Texas, June 11, 2025 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar,” the “Company,” “us” and “our”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for patients with unmet medical needs, in collaboration with Excel Diagnostics and Nuclear Oncology Center (“EDNOC”), a premier diagnostic medical imaging and therapeutic nuclear medicine center, today...Read more
BOSTON, June 10, 2025 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to mavorixafor, an oral CXCR4 antagonist, for the treatment of chronic neutropenia (CN). The company is currently conducting a global, pivotal Phase 3 clinical trial (4WARD)...Read more
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
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
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
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
Immix Biopharma is a clinical-stage biopharmaceutical company pioneering a novel class of CAR-T cell therapies and Tissue-Specific Therapeutics targeting oncology and immuno-dysregulated diseases with >75 patients treated to-date. Our lead cell therapy asset is NXC-201...
CLICK TO LEARN MORE