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Latest Biotech and Pharma FDA News

FILTER BY TOPIC:     FDA Approvals   FDA 510(k) Clearance   New Drug Application   Fast Track Designation   Orphan Drug Designation   Biologics License Application   Breakthrough Therapy Designation   Emergency Use Authorization  

Tempus AI Receives U.S. FDA Special 510(k) Clearance for Updated Tempus Pixel Device

September 11
Last Trade: 86.40 -2.38 -2.68

CHICAGO / Sep 11, 2025 / Business Wire / Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its updated Tempus Pixel, an AI-powered cardiac imaging platform. This update allows the generation of T1 and T2 inline maps, further enhancing the device’s capabilities for cardiac MR image...Read more


Amneal Pharmaceuticals Receives U.S. FDA Approval of Sodium Oxybate Oral Solution

September 11
Last Trade: 10.00 -0.09 -0.89

Expands Amneal’s Affordable Medicines portfolio and broadens patient access BRIDGEWATER, N.J, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of Amneal’s sodium oxybate oral solution 500 mg/mL Abbreviated New Drug Application (ANDA) which references Jazz Pharmaceuticals’ Xyrem®. Amneal had previously been distributing an...Read more


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

September 10
Last Trade: 72.87 -1.46 -1.96

FDA assigns a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026 REDWOOD CITY, Calif. / Sep 10, 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. Food and Drug...Read more


Travere Therapeutics Provides Update on FDA Advisory Committee Meeting for FILSPARI® (sparsentan) in FSGS

September 10
Last Trade: 23.47 -1.53 -6.12

SAN DIEGO / Sep 10, 2025 / Business Wire / Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that following further review of the supplemental New Drug Application (sNDA) for FILSPARI® (sparsentan) in focal segmental glomerulosclerosis (FSGS), an advisory committee is no longer needed. The sNDA remains under review by the FDA with a Prescription Drug User Fee...Read more


Greenwich LifeSciences’ GLSI-100 Granted US FDA Fast Track Designation

September 10
Last Trade: 11.23 -0.19 -1.66

STAFFORD, Texas, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced that FDA has granted Fast Track designation for GLSI-100 in the HLA-A*02 patient population. The designation specifically states...Read more


Teva Pharmaceutical’s Emrusolmin Granted U.S. FDA Fast Track Designation for Treatment of Multiple System Atrophy

September 9
Last Trade: 19.93 0.04 0.20

Teva received Fast Track designation from the U.S. Food and Drug Administration for emrusolmin (TEV-56286), an investigational treatment for Multiple System Atrophy (MSA) in Phase 2 development. New therapeutic options for people living with MSA, a rare and devastating neurodegenerative disorder, are urgently needed as there are no treatments available that impact disease progression. Emrusolmin is a small molecule that targets the...Read more


Ionis Pharmaceuticals receives U.S. FDA Breakthrough Therapy designation for ION582 in Angelman syndrome

September 9
Last Trade: 63.16 -0.88 -1.37

Pivotal Phase 3 REVEAL study enrollment on track to complete in 2026  CARLSBAD, Calif. / Sep 09, 2025 / Business Wire / Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ION582 for the treatment of Angelman syndrome (AS), a rare neurological disease that often presents in infancy and is characterized by profound intellectual...Read more


Microbot Medical Receives FDA 510(k) Clearance for Its LIBERTY® Endovascular Robotic System

September 8
Last Trade: 4.08 0.19 4.88

Accelerated Launch Readiness Plans Position Company for Commercialization during Q4 2025 The Company’s Initial Addressable Market Includes Approximately 2.5 Million Peripheral Endovascular Procedures in the U.S. Annually CEO, President & Chairman to Present Live Webcast at the H.C. Wainwright Annual Investor Conference on September 9, 2025, at 9 AM ET. HINGHAM, Mass., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Microbot Medical...Read more


Cocrystal Pharma Receives FDA IND Clearance for Challenge Study of Oral Broad-Spectrum Protease Inhibitor CDI-988, a Potential First Antiviral for Norovirus Prevention and Treatment

September 8
Last Trade: 1.58 0.14 9.72

There are currently no approved vaccines or treatments for norovirus infection Cocrystal’s CDI-988 is the first antiviral for the potential prevention and treatment of viral gastroenteritis caused by norovirus infections Phase 1b study is expected to start by year-end 2025 BOTHELL, Wash., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that the Company received a...Read more


BioAtla Announces Regulatory Update on Clinical Development Plan for Ozuriftamab Vedotin in Oropharyngeal Squamous Cell Carcinoma (OPSCC) Following Productive Type B (End of Phase 2) Meeting with FDA

September 8
Last Trade: 0.78 0.0009 0.12

FDA alignment on Phase 3 ozuriftamab vedotin (Oz-V) trial design, including dosing regimen and endpoints to support potential accelerated approval Company continues preparations for enabling initiation of the Phase 3 study with the goal of advancing the study with a strategic partner early next year Company maintains previous guidance for completion of a strategic partnership with one of our advanced clinical assets this year SAN...Read more


Beyond Air: NeuroNOS Granted FDA Orphan Drug Designation for Glioblastoma, the Most Common and Deadliest Primary Malignant Brain Cancer in Adults

September 8
Last Trade: 2.43 0.17 7.52

BOSTON, Sept. 08, 2025 (GLOBE NEWSWIRE) -- NeuroNOS, a biopharmaceutical company focused on developing treatments for neurological disorders and neuro-oncology, and a subsidiary of Beyond Air (NASDAQ: XAIR), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead investigational therapy, BA-101, for the treatment of Glioblastoma (GBM). GBM is an aggressive primary brain tumor...Read more


Pulse Biosciences Announces FDA IDE Approval to Initiate its nsPFA Cardiac Surgery System Study for the Treatment of Atrial Fibrillation

September 8
Last Trade: 14.52 -0.58 -3.84

HAYWARD, Calif. / Sep 08, 2025 / Business Wire / Pulse Biosciences, Inc. (Nasdaq: PLSE)(the “Company” or “Pulse Biosciences”), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) technology, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the Company’s Investigational Device Exemption (IDE), allowing Pulse Biosciences to proceed with the...Read more


Takeda: U.S. FDA Approves Expanded Indication for VONVENDI® [von Willebrand factor (Recombinant)] for Adults and Children with Von Willebrand Disease

September 5
Last Trade: 15.10 -0.24 -1.56

Approval Expands Use of VONVENDI to Include Routine Prophylaxis to Reduce the Frequency of Bleeding Episodes in Adults with Type 1 and 2 Von Willebrand Disease (VWD) and On-Demand and Perioperative Management of Bleeding in Pediatric Patients with VWD1 VONVENDI is the Only Recombinant Von Willebrand Factor Replacement Therapy with Approved Indications in Adults and Children with VWD1 VWD, the Most Common Bleeding Disorder, Impacts More...Read more


CERo Therapeutics Receives FDA Fast Track Designation for CER-1236 in Acute Myeloid Leukemia (AML)

September 5
Last Trade: 0 0.00 0.00

Regulatory milestone adds to its existing Orphan Drug Designation, creating additional regulatory and financial advantages for the Company’s lead cancer immunotherapy program SOUTH SAN FRANSCISCO, Calif., Sept. 05, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative cellular immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that...Read more


ClearPoint Neuro Announces FDA Clearance Expanding Compatibility of the ClearPoint Prism Neuro Laser Therapy System with 1.5T MRI Scanners

September 4
Last Trade: 10.49 -0.60 -5.41

SOLANA BEACH, CALIFORNIA / ACCESS Newswire / September 4, 2025 / ClearPoint Neuro, Inc. (NASDAQ:CLPT) (the "Company"), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced that the ClearPoint Prism® Neuro Laser Therapy System ("ClearPoint Prism") received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to include 1.5T MRI guidance in addition to the...Read more


Amneal Pharmaceuticals Receives U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension

September 4
Last Trade: 10.00 -0.09 -0.89

Another addition to Amneal’s growing complex injectables portfolio reflects leadership in advanced development and manufacturing of complex pharmaceuticals BRIDGEWATER, N.J., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of risperidone extended-release injectable suspension 12.5 mg/vial, 25 mg/vial, 37.5 mg/vial and 50...Read more


Eli Lilly's olomorasib receives U.S. FDA's Breakthrough Therapy designation for the treatment of certain newly diagnosed metastatic KRAS G12C-mutant lung cancers

September 4
Last Trade: 755.39 -0.89 -0.12

The Breakthrough Therapy designation for olomorasib is based on data from the Phase 1/2 LOXO-RAS-20001 trial and Phase 3 SUNRAY-01 trial Updated efficacy and safety data for olomorasib will be presented at the IASLC 2025 World Conference on Lung Cancer INDIANAPOLIS, Sept. 4, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy...Read more


Arcutis Biotherapeutics Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Cream 0.3% to Expand Indication for Treatment of Plaque Psoriasis in Children Ages 2 to 5

September 3
Last Trade: 17.29 -0.40 -2.26

If approved, ZORYVE cream would be the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children as young as 2, offering patients and caregivers an important alternative to topical steroids and vitamin-D analogs ZORYVE cream is uniquely formulated to be effective, safe, and well tolerated for all areas of the body, including sensitive areas such as intertriginous skin, where plaque psoriasis often presents in...Read more


Lantern Pharma Announces Completion of Type C Meeting with FDA, Providing Clarity on Regulatory Pathway for Pediatric CNS Cancer Trial

September 3
Last Trade: 3.83 -0.10 -2.54

DALLAS / Sep 03, 2025 / Business Wire / Lantern Pharma Inc. (NASDAQ: LTRN), an AI-driven clinical -stage oncology company developing targeted therapies for cancer that are being advanced using its proprietary computational biology and machine learning platform, today announced the successful completion of a Type C meeting with the U.S. Food and Drug Administration (FDA). The meeting provided critical guidance on the regulatory pathway and...Read more


Achieve Life Sciences Announces FDA Acceptance of Cytisinicline New Drug Application for Treatment of Nicotine Dependence for Smoking Cessation

September 3
Last Trade: 3.08 -0.08 -2.53

Filing based on pivotal Phase 3 ORCA-2 and ORCA-3 clinical trials demonstrating statistically significant and clinically meaningful smoking cessation FDA acceptance starts the review process and sets timing for potentially the first new FDA-approved pharmacotherapy in two decades PDUFA targeted date set for June 20, 2026 SEATTLE and VANCOUVER, British Columbia, Sept. 03, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc....Read more


IDEAYA Biosciences Announces IND Submission for IDE892, a Potential Best-In-Class PRMT5 Inhibitor for MTAP-Deletion Solid Tumors

September 3
Last Trade: 24.61 -0.31 -1.24

Dosing of first patient in Phase 1 dose escalation trial of IDE892 targeted in 4Q 2025 Preclinical profile of IDE892 and mechanistic combination rationale with IDE397, IDEAYA's proprietary MAT2A inhibitor, will be presented at the 10-Year Anniversary R&D Day on September 8th SOUTH SAN FRANCISCO, Calif., Sept. 3, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, announced...Read more


Eisai Initiated Rolling Supplemental Biologics License Application to the U.S. FDA for LEQEMBI® IQLIK™ (lecanemab-irmb) as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer’s Disease Under Fast Track Status

September 2
Last Trade: 144.86 -3.98 -2.67

LEQEMBI IQLIK, if approved for initiation dosing, would be the first and only anti-amyloid treatment to offer at-home injection from the start to help patients and care partners treat this progressive, relentless disease TOKYO and CAMBRIDGE, Mass., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO:...Read more


Medtronic: FDA Clears MiniMed™ 780G System to Enable Integration with the Instinct Sensor, Made by Abbott, and Approves Use in Type 2 Diabetes

September 2
Last Trade: 94.03 -0.22 -0.23

GALWAY, Ireland, Sept. 2, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced two U.S. Food and Drug Administration (FDA) regulatory milestones that broaden the MiniMed™ 780G system portfolio: clearance of the SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC), enabling integration with the Instinct sensor, made by Abbott, for type 1 diabetes, and approval...Read more


OS Therapies Provides OST-HER2 Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma Program Update Following FDA End of Phase 2 Meeting

September 2
Last Trade: 2.25 -0.06 -2.60

Company on track to begin submission of a rolling Biologics Licensing Application (BLA) request for OST-HER2 to U.S. Food & Drug Administration in September 2025 New York, New York--(Newsfile Corp. - September 2, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today provided stakeholders with a detailed...Read more


Rezolute Announces Alignment with FDA on Streamlined Design for Ongoing Phase 3 Trial of Ersodetug in Tumor Hyperinsulinism

September 2
Last Trade: 7.69 -0.28 -3.51

Open-label study in as few as 16 tumor hyperinsulinism (HI) patients Study initiated and enrolling patients in the U.S. and Europe Topline data expected in the second half of 2026 REDWOOD CITY, Calif., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, today announced that the Company has gained...Read more


US Food and Drug Administration (FDA) Approves Henlius and Organon’s BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively

September 2
Last Trade: 10.65 -0.01 -0.09

SHANGHAI & JERSEY CITY, N.J. / Sep 02, 2025 / Business Wire / Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the US Food and Drug Administration (FDA) has approved BILDYOS® (denosumab-nxxp) injection 60 mg/mL and BILPREVDA® (denosumab-nxxp) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products.1,2 “The FDA...Read more


QIAGEN Gains U.S. Clearance of Higher-Throughput QIAstat-Dx Rise, Expanding Patient Access to Rapid Syndromic Testing

September 2
Last Trade: 45.28 -0.78 -1.69

U.S. market entry set to begin for QIAstat-Dx Rise – a version of QIAstat-Dx for syndromic testing that combines unparalleled throughput with the easiest workflow QIAstat-Dx Rise launch can process up to 160 samples per day, initial launch includes Respiratory Panel Plus and Respiratory Panel Mini and additional panels in development Expansion of QIAstat-Dx instrument portfolio in the U.S. builds on the availability of both system...Read more


FDA Approves LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection for Maintenance Dosing for the Treatment of Early Alzheimer's Disease

August 29
Last Trade: 144.86 -3.98 -2.67

LEQEMBI IQLIK is the first and only anti-amyloid treatment to offer an at-home injection to help patients and care partners continue to treat this progressive, relentless disease after initial treatment of 18 months LEQEMBI IQLIK will be launched on October 6, 2025, in the U.S. TOKYO and CAMBRIDGE, Mass., Aug. 29, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai")  and Biogen Inc. (Nasdaq:...Read more


Teva Pharmaceutical Announces FDA Approval and Launch of Generic Saxenda® (liraglutide injection) – First Generic GLP-1 Indicated for Weight Loss

August 28
Last Trade: 19.93 0.04 0.20

Generic Saxenda® is the first-ever generic GLP-1 indicated for weight loss, addressing increased demand for this category of therapies in the U.S. market. This approval and launch add to Teva’s continued commitment to its complex generic medicine portfolio as part of its Pivot to Growth Strategy. Liraglutide injection is indicated for adults with obesity or overweight (excess weight) who also have weight related medical problems, and...Read more


Vanda Pharmaceuticals Announces FDA Granted Orphan Drug Designation for VGT-1849B, a Novel and Selective Candidate for the Treatment of Polycythemia Vera

August 28
Last Trade: 4.51 -0.09 -1.96

WASHINGTON, Aug. 28, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for VGT-1849B, a selective peptide nucleic acid-based JAK2 inhibitor for the treatment of polycythemia vera (PV). PV is a chronic myeloproliferative disorder characterized by aberrant hematopoiesis of myeloid lineage with exuberant red cell production...Read more


Outlook Therapeutics Provides Regulatory Update on U.S. Food and Drug Administration Review of ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD

August 28
Last Trade: 1.04 -0.05 -4.59

FDA issues Complete Response Letter (CRL) for resubmitted ONS-5010 BLA Outlook Therapeutics plans to work with FDA to address the Agency’s issues Company to host a conference call and webcast today, August 28th at 8:30 AM ET ISELIN, N.J., Aug. 28, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina...Read more


Travere Therapeutics Announces U.S. FDA Approves REMS Modification for FILSPARI® (sparsentan) in IgA Nephropathy

August 27
Last Trade: 23.47 -1.53 -6.12

FDA simplifies liver monitoring schedule from monthly to every three months for the duration of treatment and removes embryo-fetal toxicity REMS monitoring SAN DIEGO / Aug 27, 2025 / Business Wire / Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the U.S. Food and Drug Administration (FDA) has approved updated Risk Evaluation and Mitigation Strategy (REMS) labeling for FILSPARI® (sparsentan), the only Dual Endothelin...Read more


Novavax's Nuvaxovid™ 2025-2026 Formula COVID-19 Vaccine Approved in the U.S.

August 27
Last Trade: 7.98 -0.30 -3.62

Nuvaxovid™ is the only protein-based, non-mRNA COVID-19 vaccine available in the U.S. for the 2025-2026 vaccination season GAITHERSBURG, Md., Aug. 27, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced that the U.S. Food and Drug Administration has approved the Nuvaxovid™ 2025-2026 Formula for the prevention of COVID-19 in adults 65 years and older or individuals 12 years through 64 years of age with at least...Read more


Pfizer and BioNTech’s COMIRNATY® Receives U.S. FDA Approval for Adults 65 and Older and Individuals Ages 5 through 64 at Increased Risk for Severe COVID-19

August 27
Last Trade: 23.87 -0.99 -3.98

The 2025-2026 COVID-19 vaccine formulation targets the SARS-CoV-2 sublineage LP.8.1, in line with FDA guidance to more closely match circulating strains1 Shipping of the LP.8.1-adapted vaccine will begin immediately to ensure robust supply and rapid access of this season’s vaccine in pharmacies, hospitals, and clinics across the country NEW YORK & MAINZ, Germany / Aug 27, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE, “Pfizer”)...Read more


Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccines Targeting LP.8.1 Variant of SARS-CoV-2

August 27
Last Trade: 23.62 -1.77 -6.97

CAMBRIDGE, MA / ACCESS Newswire / August 27, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Applications (sBLA) for the 2025-2026 formulas for Spikevax® and mNEXSPIKE®, targeting the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19. The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age with...Read more


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

August 27
Last Trade: 3.15 -0.07 -2.17

FDA Establishes April 23, 2026 as PDUFA Target Date for Review of Submission Seeking Approval for GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH) Comprehensive Data Package Supported by Positive Results from Phase 3 STRIVE-ON Safety Trial of GTx-104 PRINCETON, N.J., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage,...Read more


Bayer: Gadoquatrane New Drug Application Accepted for Review by U.S. FDA

August 27
Last Trade: 8.24 -0.21 -2.49

New Drug Application (NDA) for low-dose contrast agent gadoquatrane seeks approval for contrast-enhanced magnetic resonance imaging (MRI) of the central nervous system (CNS) and other body regions for adults and pediatric patients including neonates Submitted dose corresponds to a 60 percent reduction in gadolinium compared to macrocyclic gadolinium-based contrast agents (GBCAs) dosed at 0.1 mmol gadolinium per kilogram of body...Read more


Genmab Receives FDA Breakthrough Therapy Designation for Rinatabart Sesutecan (Rina-S®) in Advanced Endometrial Cancer (EC)

August 26
Last Trade: 27.82 -0.80 -2.80

Breakthrough Therapy Designation granted to Rina-S for the treatment of adult patients with recurrent or progressive endometrial cancer (EC) who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy Regulatory decision supported by data from the Phase 1/2 RAINFOL™-01 trial showing encouraging responses in heavily pretreated EC patientsi Rina-S continues to be evaluated as a...Read more


Allarity Therapeutics Granted FDA Fast Track Designation for Stenoparib for the Treatment of Advanced Ovarian Cancer

August 26
Last Trade: 1.66 -0.20 -10.75

TARPON SPRINGS, Fla., August 26, 2025 -- Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor—today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to stenoparib, its investigational treatment for patients with advanced ovarian...Read more


Serina Therapeutics Announces FDA Feedback Supports Registrational Trial Design of SER-252 in Advanced Parkinson’s Disease under 505(b)(2) NDA Pathway

August 25
Last Trade: 5.19 0.09 1.76

U.S. IND filing planned for Q4 2025 with U.S. enrollment expected to start in Q1 2026 Patient dosing expected to begin in Australia in Q4 2025 HUNTSVILLE, AL, Aug. 25, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina”) (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform™ drug optimization technology, today announced that following a recent Type B meeting with...Read more


Repatha® Now Indicated For Adults At Increased Risk For Major Adverse Cardiovascular Events Due To Uncontrolled LDL-C

August 25
Last Trade: 276.39 -6.34 -2.24

THOUSAND OAKS, Calif., Aug. 25, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has broadened the approved use of Repatha® (evolocumab) to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C), commonly known as 'bad cholesterol.' The update removes a prior requirement for a patient to have...Read more


FDA Grants Breakthrough Device Designation for Haystack MRD Circulating Tumor DNA Test from Quest Diagnostics

SECAUCUS, N.J., Aug. 25, 2025 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company's Haystack MRD® test for identifying MRD-positive patients with stage II colorectal cancer following curative-intent surgical treatment who may benefit from adjuvant therapy...Read more


Coya Therapeutics Announces FDA Acceptance of Investigational New Drug (IND) Application for COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

August 25
Last Trade: 6.05 -0.16 -2.58

FDA acceptance enables initiation of a Phase 2 multicenter, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of COYA 302 in patients with ALS HOUSTON, Aug. 25, 2025 /PRNewswire/ -- Coya Therapeutics, Inc. (NASDAQ: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with...Read more


Protagonist Therapeutics: Rusfertide Receives Breakthrough Therapy Designation for Treatment of Erythrocytosis in Patients with Polycythemia Vera

August 25
Last Trade: 58.86 -0.82 -1.37

Breakthrough Therapy designation complements Rusfertide's Orphan Drug and Fast Track designations, which together confer multiple benefits to the development program U.S. New Drug Application filing for Rusfertide in polycythemia vera on track for Q4 NEWARK, CA / ACCESS Newswire / August 25, 2025 / Protagonist Therapeutics, Inc. ("Protagonist" or "the Company") announced today that rusfertide, a potential first-in-class...Read more


Ionis Pharmaceuticals: DAWNZERA™ (donidalorsen) approved in the U.S. as first and only RNA-targeted prophylactic treatment for hereditary angioedema

August 21
Last Trade: 63.16 -0.88 -1.37

DAWNZERA demonstrated significant and sustained HAE attack rate reduction and long-term disease control Offers longest dosing option for HAE, with dosing every 4 or 8 weeks Compelling profile supported by recently published switch data Ionis’ second independent launch in just nine months, with potential for two additional launches next year Ionis to host webcast today at 12:15pm ET CARLSBAD, Calif. / Aug 21, 2025 / Business Wire /...Read more


Shattuck Labs Announces IND for SL-325 Is in Effect for the Treatment of Inflammatory Bowel Disease

August 21
Last Trade: 1.92 -0.06 -3.03

SL-325 is a potentially first-in-class DR3 antagonist antibody being developed for the treatment of Inflammatory Bowel Disease (IBD) and other inflammatory and immune-mediated diseases The Company is on track to dose the first participant in its Phase 1 SL-325 clinical trial in healthy volunteers in Q3 2025 Current cash and cash equivalents, plus the anticipated aggregate proceeds of up to $103 million from recent private placement,...Read more


Crinetics Pharmaceuticals Receives FDA Orphan Drug Designation for Atumelnant in the Treatment of Congenital Adrenal Hyperplasia (CAH)

August 21
Last Trade: 34.00 0.27 0.80

SAN DIEGO, Aug. 21, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for atumelnant, a novel, once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist candidate for the proposed treatment of classic congenital adrenal hyperplasia (CAH). Atumelnant is the first and only small molecule ACTH receptor...Read more


Nuwellis Receives FDA 510(k) Clearance for New Dual Lumen Extended Length Catheter

August 21
Last Trade: 4.18 -0.03 -0.71

MINNEAPOLIS, Aug. 21, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on fluid management, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for a new size of its Dual Lumen Extended Length Catheter (dELC). Advancing a broader fluid management platform: This clearance supports Nuwellis’ multi-year plan to build a comprehensive fluid management...Read more


Rhythm Pharmaceuticals Announces FDA Acceptance of sNDA for Setmelanotide in Acquired Hypothalamic Obesity

August 20
Last Trade: 96.22 -1.70 -1.74

U.S. Food and Drug Administration accepts sNDA for filing with priority review; sets PDUFA goal date of December 20, 2025  European Medicines Agency accepts and validates submission for Type II variation MAA for setmelanotide to treat acquired hypothalamic obesity  Company to host “Commercial Readiness for Acquired Hypothalamic Obesity,” event for investors and analysts on Wednesday, September 24, in Boston  BOSTON,...Read more


Regeneron Pharmaceuticals: EYLEA HD® (aflibercept) Injection 8 mg Applications for Expanded U.S. Label and Prefilled Syringe Receive FDA Review Period Extension

August 20
Last Trade: 560.00 -8.20 -1.44

TARRYTOWN, N.Y., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has extended the target action dates to the fourth quarter of 2025 for two EYLEA HD® (aflibercept) Injection 8 mg regulatory submissions. This includes a Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the EYLEA HD prefilled syringe and a...Read more


Keros Therapeutics Announces U.S. FDA Orphan Drug Designation Granted to KER-065 for the Treatment of Duchenne Muscular Dystrophy

August 20
Last Trade: 15.66 -0.10 -0.63

LEXINGTON, Mass., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (“TGF-ß”) family of proteins, today announced the U.S. Food and Drug Administration (“FDA”) granted...Read more


Tivic Health Systems Receives Two Investigational New Drug Applications for Entolimod™ for the Treatment of Acute Radiation Syndrome (ARS) and Advanced Cancers

August 20
Last Trade: 3.11 0.04 1.30

INDs Transferred from Statera Biopharma Advance Entolimod for ARS Along Regulatory Pathway and Enable Pursuit of Clinical Trial Program in Neutropenia and Lymphocyte Exhaustion FREMONT, Calif. / Aug 20, 2025 / Business Wire / Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified immunotherapeutics company, today announced it has received, from Statera Biopharma, two investigational new drug applications (INDs) for its lead...Read more


Agilent Technologies MMR IHC Panel pharmDx (Dako Omnis) Receives FDA Approval as a Companion Diagnostic Test for Colorectal Cancer

August 20
Last Trade: 123.24 -3.49 -2.75

SANTA CLARA, Calif. / Aug 20, 2025 / Business Wire / Agilent Technologies Inc. (NYSE: A) today announced that its MMR IHC Panel pharmDx (Dako Omnis) has received FDA approval as a companion diagnostic (CDx) test for colorectal cancer. This test aids in identifying mismatch repair deficient (dMMR) colorectal cancer (CRC) patients who are eligible for treatment with Bristol Myers Squibb’s Opdivo® (nivolumab) alone or Opdivo (nivolumab) in...Read more


CytoSorbents Updates U.S. FDA Regulatory Status of DrugSorb-ATR

August 20
Last Trade: 0.94 -0.02 -1.60

FDA appeal decision found no issues with DrugSorb-ATR device safety but upheld the De Novo denial, and proposes a potential path forward for market authorization PRINCETON, N.J., Aug. 20, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, updates the regulatory status of its appeal with the...Read more


enVVeno Medical Receives Not-Approvable Letter from the FDA for the VenoValve(R)

August 20
Last Trade: 0.78 -0.005 -0.64

IRVINE, CA / ACCESS Newswire / August 20, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that it has received a not-approvable letter from the U.S. Food & Drug Administration (FDA) in response to its Premarket Approval (PMA) application for VenoValve®, a surgical replacement venous valve for treating severe...Read more


PTC Therapeutics Receives Complete Response Letter for Vatiquinone NDA

August 19
Last Trade: 61.09 0.13 0.21

WARREN, N.J., Aug. 19, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) related to the New Drug Application (NDA) for vatiquinone for the treatment of children and adults living with Friedreich's ataxia. "We are of course disappointed by the FDA's decision to not approve vatiquinone," said Matthew B. Klein, M.D., Chief...Read more


Masimo O3® Regional Oximetry Receives FDA Clearance for Expanded Indication of Its Unique Delta Hemoglobin Parameters

August 19
Last Trade: 147.44 1.23 0.84

Now Available for Both Cerebral and Somatic Applications and for All Patient Populations, O3’s Delta Hemoglobin Parameters Offer Clinicians Additional Insight Into Changes in Tissue Oxygen Saturation IRVINE, Calif. / Aug 19, 2025 / Business Wire / Masimo (NASDAQ: MASI) today announced the FDA 510(k) clearance of expanded indications for the delta hemoglobin parameters provided with O3® Regional Oximetry. The parameters (ΔcHb, ΔHHb, and...Read more


Altimmune Announces FDA Fast Track Designation for Pemvidutide in Alcohol Use Disorder (AUD)

August 19
Last Trade: 3.64 -0.05 -1.36

Pemvidutide is the only drug currently granted Fast Track Designation in AUD RECLAIM, a Phase 2 trial of pemvidutide in AUD, is currently enrolling GAITHERSBURG, Md., Aug. 19, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing peptide-based therapeutics for liver and cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted...Read more


Aldeyra Therapeutics Receives Fast Track Designation for ADX‑2191 for the Treatment of Retinitis Pigmentosa

August 19
Last Trade: 5.39 -0.17 -3.06

LEXINGTON, Mass. / Aug 19, 2025 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for ADX-2191 (methotrexate intravitreal injection, USP) for the treatment of retinitis pigmentosa. There is currently no approved treatment for patients with most forms of retinitis pigmentosa, a clinical group of rare genetic eye diseases...Read more


REGENXBIO Announces FDA Review Extension of BLA for RGX-121 to Treat Patients with MPS II

August 18
Last Trade: 9.20 -0.29 -3.06

RGX-121 would be the first and only potential one-time commercially-available therapy designed to directly address the underlying genetic cause of Hunter syndrome, if approved Commercial launch plans remain on track  REGENXBIO plans to present updated pivotal data during the ICIEM meeting in September 2025 ROCKVILLE, Md., Aug. 18, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that the U.S. Food and Drug...Read more


NeuroOne Medical Technologies Receives FDA 510(k) Clearance for OneRF® Trigeminal Nerve Ablation System to Treat Facial Pain

August 18
Last Trade: 0.89 -0.0053 -0.59

FDA Clearance Further Validates Technology Platform and Offers Alternatives to Pharmaceutical and Invasive Surgical Treatments EDEN PRAIRIE, Minn., Aug. 18, 2025 (GLOBE NEWSWIRE) -- NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) ("NeuroOne" or the "Company"), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, has received U.S. Food and...Read more


Ultragenyx Pharmaceutical Initiates Rolling Submission of Biologics License Application (BLA) to U.S. FDA for DTX401 AAV Gene Therapy for the Treatment of Glycogen Storage Disease Type Ia (GSDIa)

August 18
Last Trade: 30.31 -0.92 -2.95

Company expects to complete BLA submission in the fourth quarter of 2025 NOVATO, Calif., Aug. 18, 2025 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced the initiation of a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for DTX401 AAV gene therapy as a treatment for Glycogen Storage Disease Type Ia (GSDIa). The company has...Read more


FDA Grants Soligenix Orphan Drug Designation for the Treatment of Behçet's Disease after Reviewing Recent Phase 2 Clinical Study Results

August 18
Last Trade: 2.92 0.14 5.04

Provides SGX945 Seven Years of U.S. Market Exclusivity Upon FDA Approval  PRINCETON, N.J., Aug. 18, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products Development of the United States (U.S.) Food and...Read more


Merck: Ifinatamab Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with Pretreated Extensive-Stage Small Cell Lung Cancer

August 18
Last Trade: 82.81 -2.34 -2.75

Data from IDeate-Lung01 trial will be presented at upcoming IASLC 2025 World Conference on Lung Cancer First Breakthrough Therapy Designation for Daiichi Sankyo and Merck’s ifinatamab deruxtecan based on IDeate-Lung01 phase 2 trial, with support from IDeate-PanTumor01 phase 1/2 trial Fourteenth Breakthrough Therapy Designation granted by FDA across the oncology portfolio of Daiichi Sankyo BASKING RIDGE, N.J. & RAHWAY, N.J. / Aug...Read more


BioXcel Therapeutics Announces Positive FDA Pre-sNDA Meeting Comments for sNDA Submission for BXCL501 in Agitation Associated with Bipolar Disorders or Schizophrenia

August 18
Last Trade: 3.11 -0.28 -8.26

Achieved alignment with the FDA on sNDA package to expand the IGALMI label for the At-Home (Outpatient) setting sNDA submission on track for Q1 2026 NEW HAVEN, Conn., Aug. 18, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that it has received positive pre-sNDA meeting responses...Read more


Bristol-Myers Squibb: Izalontamab Brengitecan (EGFRxHER3 ADC) Granted Breakthrough Therapy Designation by U.S. FDA for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer

August 18
Last Trade: 46.20 -1.34 -2.82

First Breakthrough Therapy Designation in the U.S. for SystImmune and Bristol Myers Squibb's Izalontamab brengitecan (Iza-bren) based on data from the BL-B01D1-101 (CN), BL-B01D1-203 (CN), and BL-B01D1-LUNG-101 (U.S.,/EU) studies REDMOND, Wash. and PRINCETON, N.J., Aug. 18, 2025 /PRNewswire/ -- SystImmune Inc. (SystImmune), a clinical-stage biotechnology company, and Bristol Myers Squibb (NYSE: BMY) today announced that the U.S....Read more


Ascentage Pharma Announces Global Registrational Phase III Study of Lisaftoclax for First-line Treatment of Patients with Higher-Risk Myelodysplastic Syndrome Cleared by US FDA and EMA

August 17
Last Trade: 40.46 0.57 1.43

ROCKVILLE, Md. and SUZHOU, China, Aug. 17, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced that it has received clearance by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)...Read more


Novo Nordisk: Wegovy® approved by FDA for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis

August 15
Last Trade: 54.87 0.57 1.05

Wegovy® (semaglutide) injection 2.4 mg is now indicated to treat adults with metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver, in conjunction with a reduced calorie diet and increased physical activity1 The accelerated approval is based on Part 1 of the ESSENCE trial, in which Wegovy® demonstrated a statistically significant improvement...Read more


Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia

August 15
Last Trade: 28.61 -2.60 -8.33

Tonmya is the first FDA-approved therapy for the treatment of fibromyalgia in over 15 years Fibromyalgia is a chronic pain condition that affects more than 10 million adults in the U.S. who are mostly women Two Pivotal Phase 3 studies demonstrated Tonmya significantly reduced fibromyalgia pain compared to placebo; generally well tolerated Commercial availability of Tonmya is expected in the fourth quarter Company to host webcast...Read more


Precigen Announces Full FDA Approval of PAPZIMEOS (zopapogene imadenovec-drba), the First and Only Approved Therapy for the Treatment of Adults with Recurrent Respiratory Papillomatosis

August 15
Last Trade: 3.80 -0.34 -8.21

PAPZIMEOS approval marks a historic milestone for the RRP patient community as the first and only FDA-approved therapy for the treatment of adults with RRP PAPZIMEOS received full approval from the FDA for the treatment of adults with RRP; a confirmatory clinical trial is no longer required  RRP is a rare, debilitating, and potentially life-threatening disease caused by chronic HPV 6 or HPV 11 infection, which results in...Read more


Invivyd Aligns with U.S. FDA on Rapid Pathway to Full Approval (BLA) of Vaccine Alternative Monoclonal Antibody VYD2311 to Protect American Adults and Adolescents from COVID-19

August 14
Last Trade: 1.41 0.18 14.63

Alignment follows Type C meeting for VYD2311 as previously disclosed BLA pathway for VYD2311 to be supported by a single, Phase 2/3 randomized, double-blind, placebo-controlled trial with a primary endpoint of reduction in symptomatic COVID-19, resembling CANOPY Cohort B Company’s target product profile is low-dose, intramuscular, scalable, low-cost, long-lasting, protective option for target populations, including adults and...Read more


Beam Therapeutics Announces U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to BEAM-101 for the Treatment of Sickle Cell Disease

August 14
Last Trade: 20.60 -0.95 -4.41

CAMBRIDGE, Mass., Aug. 14, 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 granted Regenerative Medicine Advanced Therapy (RMAT) designation to BEAM-101, an investigational genetically modified cell therapy for the treatment of sickle cell disease...Read more


Creative Medical Technology Secures FDA Fast Track Designation for CELZ-201-DDT - Advancing Breakthrough Therapy for Chronic Lower Back Pain

August 13
Last Trade: 3.50 0.01 0.29

PHOENIX, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a clinical-stage biotechnology company focused on regenerative and immune cellular therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead investigational therapy, CELZ-201-DDT, for the treatment of degenerative disc disease (DDD), a major cause of chronic lower back pain...Read more


Cognition Therapeutics Receives End-of-Phase 2 Meeting Minutes Confirming Alignment with U.S. FDA on Registrational Path for Zervimesine (CT1812) in Alzheimer’s Disease

August 12
Last Trade: 2.17 -0.19 -8.05

Cognition and FDA align on enriched population, study design, and endpoints  PURCHASE, N.Y., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, received final minutes from the U.S. Food and Drug Administration (FDA) pertaining to the end-of-Phase 2 meeting that was conducted on July 9, 2025....Read more


Insmed: FDA Approves BRINSUPRI™ (brensocatib) as the First and Only Treatment for Non-Cystic Fibrosis Bronchiectasis, a Serious, Chronic Lung Disease

August 12
Last Trade: 145.93 0.14 0.10

Approximately 500,000 U.S. Patients Are Diagnosed with Non-Cystic Fibrosis Bronchiectasis (NCFB), a Progressive Disease That Can Lead to Permanent Lung Damage BRINSUPRI 10 mg and 25 mg Doses Approved for the Treatment of NCFB BRINSUPRI, a First-in-Class DPP1 Inhibitor Targeting Neutrophilic Inflammation, Is Available by Prescription Through a Comprehensive Specialty Pharmacy Network Insmed to Host Investor Conference Call...Read more


Ocular Therapeutix Receives FDA Agreement Under Special Protocol Assessment (SPA) for Registrational Trial of AXPAXLI™ in NPDR

August 12
Last Trade: 12.81 0.05 0.39

Ocular plans to outline clinical trial design, timing, and development strategy for non-proliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME) at its Investor Day on September 30, 2025 BEDFORD, Mass., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced it has received written...Read more


Viatris Announces Approval of First Generic Iron Sucrose Injection in the U.S.

August 11
Last Trade: 9.96 -0.21 -2.06

Approval is Another Milestone of Viatris' Ability to Successfully Develop Complex Generic Medicines Approval Granted with Competitive Generic Therapy Eligibility for 100mg/5mL and 200mg/10mL Strengths; Provides Eligibility for 180 Days of Exclusivity PITTSBURGH, Aug. 11, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced the U.S. Food and Drug Administration (FDA) has approved Iron...Read more


PharmaTher Announces FDA Approval of Ketamine (KETARx™)

August 11
Last Trade: 0.36 -0.02 -4.05

TORONTO, Aug. 11, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on unlocking the pharmaceutical potential of ketamine, is pleased to announce today that the U.S. Food and Drug Administration (FDA) has approved the Company’s ketamine product, herein referred to as KETARx™, on August 8th, 2025, for its indicated uses in surgical pain...Read more


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

August 11
Last Trade: 1.69 -0.10 -5.59

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


NRx Pharmaceuticals Granted FDA Fast Track Designation for NRX-100 for Suicidal Ideation in Patients with Depression, including Bipolar Depression

August 11
Last Trade: 2.84 -0.04 -1.39

This designation expands the addressable population for NRX-100 to the 13 million Americans who consider suicide each year and represents a 10x expansion of the addressable population compared to the Designation granted in 2017 for bipolar depression alone The Designation includes an FDA determination that NRX-100 has the potential to address an unmet need, based on FDA's assessment of the data submitted Determination of "unmet need"...Read more


Kamada Announces FDA Approval of its Plasma Collection Center in Houston, Texas

August 11
Last Trade: 7.02 0.00 0.00

Houston Center Cleared to Commence Commercial Sales of Normal Source Plasma State of the Art Facility has Annual Collection Capacity of Approximately 50,000 Liters of Plasma and an Estimated Annual Revenue Contribution of $8 Million to $10 Million at its Full Capacity Center is Structured to Collect Normal Source Plasma and Specialty Plasma, such as Anti-Rabies and Anti-D; Anticipated to be One of the Largest Sites for Specialty...Read more


Amphastar Pharmaceuticals Announces FDA Approval for Iron Sucrose Injection, USP

August 11
Last Trade: 28.06 -0.62 -2.16

According to the FDA, Amphastar's iron sucrose injection meets the criteria for bioequivalence and therapeutic equivalence to Venofer® for the treatment of iron deficiency anemia in patients with chronic kidney disease RANCHO CUCAMONGA, CA / ACCESS Newswire / August 11, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH), a biopharmaceutical company focused on developing, manufacturing, and marketing complex generic and proprietary...Read more


Nyxoah Receives Approval from FDA for Genio® System for the Treatment of Obstructive Sleep Apnea

August 8
Last Trade: 5.24 -0.31 -5.59

U.S. Commercialization Officially Launched Mont-Saint-Guibert, Belgium – August 8, 2025, 10:10pm CET / 4:10pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the U.S. Food and Drug Administration (FDA) has approved the Genio system for a subset of...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: 7.74 -0.07 -0.90

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


Capricor Therapeutics Announces Type A Meeting Scheduled with U.S. FDA

August 8
Last Trade: 6.36 -0.08 -1.24

Second Quarter 2025 Financial Results and Corporate Update Rescheduled to Monday, August 11, 2025, at 4:30 p.m. ET – SAN DIEGO, Aug. 08, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled to...Read more


FDA Grants Nutriband Meeting Request for Aversa™ Fentanyl Abuse Deterrent Fentanyl Patch

August 8
Last Trade: 7.00 0.07 1.01

FDA grants meeting for AVERSA™ FENTANYL (abuse deterrent transdermal system) to provide feedback on the Chemistry, Manufacturing, and Controls plans for the product through commercialization. Nutriband is partnering with Kindeva to develop AVERSA™ FENTANYL which combines Nutriband’s AVERSA™ abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch. ORLANDO, Fla., Aug. 08, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc....Read more


FibroGen Announces Positive Type C Meeting with the FDA for Roxadustat in Patients with Anemia Associated with Lower-Risk Myelodysplastic Syndromes

August 7
Last Trade: 12.03 -0.40 -3.22

FibroGen has reached agreement with the FDA on important design elements for a pivotal Phase 3 clinical trial for roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS) and high red blood cell (RBC) transfusion burden Company intends to file the Phase 3 protocol in the fourth quarter of 2025 SAN FRANCISCO, Aug. 07, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today...Read more


DeepHealth, a RadNet Subsidiary, Receives FDA Clearance for Remote Scanning Solution, TechLive™

August 7
Last Trade: 74.01 0.28 0.38

TechLive™ is a vendor-agnostic integrated solution enabling remote scanning of MR, CT, PET/CT, and Ultrasound procedures Amidst radiology technologist shortages, remote scanning in a command center configuration enables the workforce to scan at multiple locations simultaneously with a high level of expertise RadNet has connected more than 300 MR, CT, PET/CT, and Ultrasound systems with TechLive™, delivering operational efficiency and...Read more


Jazz Pharmaceuticals Announces U.S. FDA Approval of Modeyso™ (dordaviprone) as the First and Only Treatment for Recurrent H3 K27M-mutant Diffuse Midline Glioma

August 6
Last Trade: 126.16 -2.30 -1.79

Modeyso is the first treatment option for this ultra-rare and aggressive brain tumor, which primarily affects children and young adults Accelerated approval based on an overall response rate in patients with progressive disease following prior therapy Company to host investor webcast on August 27, 2025 For U.S. media and investors only DUBLIN, Aug. 5, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today...Read more


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

August 6
Last Trade: 3.95 0.02 0.51

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


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