Ascendis Announces Extension of FDA Review Period for TransCon CNP (navepegritide) for Children with Achondroplasia
November 25, 2025 18:15 ET | Source: Ascendis Pharma – Prescription Drug…
Vera Therapeutics Submits Biologics License Application to U.S. FDA through Accelerated Approval Program for Atacicept for the Treatment of Adults with IgA Nephropathy
Atacicept received FDA Breakthrough Therapy Designation for the treatment of IgANORIGIN Phase…
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…
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.…
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.,…
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…
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…
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…
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…
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.,…
