fda

Ofirnoflast (HT-6184) Receives Orphan Drug Designation from U.S. FDA for Myelodysplastic Syndromes

LEHI, Utah, Oct. 23, 2025 /PRNewswire/ -- Halia Therapeutics, Inc., a clinical-stage biopharmaceutical company pioneering therapies that target the root causes…

3 months ago

Revolution Medicines Awarded Voucher for Daraxonrasib (RMC-6236) Under FDA Commissioner’s National Priority Voucher Pilot Program

REDWOOD CITY, Calif., Oct. 16, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing…

4 months ago

Lords Mark Industries Ltd. secures US FDA Registration, Reinforces Indias Position in Global Healthcare Manufacturing

MUMBAI, India, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Lords Mark Industries Ltd., has received US FDA registration for its range…

4 months ago

FDA Approves Expanded Indication for UZEDY (risperidone) Extended-Release Injectable Suspension as a Treatment for Adults Living with Bipolar I Disorder

FDA approves UZEDY® (risperidone) extended-release injectable suspension for subcutaneous use as monotherapy or as adjunctive therapy to lithium or valproate…

4 months ago

FDA approves Roches Tecentriq plus lurbinectedin as first-line maintenance therapy for extensive-stage small cell lung cancer

Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase…

4 months ago

Press Release Biocartis NV: Biocartis Receives FDA Approval for the Idylla CDx MSI Test

PRESS RELEASE - 09/15/2025, 09:00 AM EDT Biocartis Receives FDA Approval for the Idylla™ CDx MSI Test First-ever fully automated,…

5 months ago

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 Alzheimers Disease Under Fast Track Status

LEQEMBI IQLIK, if approved for initiation dosing, would be the first and only anti-amyloid treatment to offer at-home injection from…

5 months ago

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

August 20, 2025 09:48 ET  | Source: Keros Therapeutics, Inc. LEXINGTON, Mass., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Keros Therapeutics,…

6 months ago

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

ROCKVILLE, Md. and SUZHOU, China, Aug. 17, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global, commercial…

6 months ago

Respiree Secures Second FDA 510(k) Clearance, Expands Cardio-Respiratory Wearable to Home Use via 1Bio Connected Care Platform

HOUSTON and SINGAPORE, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Respiree, a health tech company developing artificial intelligence (AI) platforms to…

6 months ago
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