EMA’s Advisory Committee Backs Approval Of BioMarin’s Dwarfism Candidate
European Medical Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the…
Mirati’s KRAS Inhibitor Receives FDA Breakthrough Tag For Lung Cancer Harboring KRAS Mutation
The FDA has granted Breakthrough Therapy designation to Mirati Therapeutics Inc’s (NASDAQ:MRTX) adagrasib in non-small cell lung cancer (NSCLC) patients with the…
FDA AdCom In Favor Of Delaying Incyte’s Retifanlimab Approval In Anal Cancer
Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte Corporation’s (NASDAQ:INCY) retifanlimab…
Y-mAbs Reports European Medicines Agency’s Committee For Orphan Medicinal Products Recommended Granting Orphan Medicinal Product Designation In EU For Medulloblastoma Treatment
Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (NASDAQ:YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based
FDA Denies Adial Pharma’s Fast Track Request For AD04 in Alcohol Use Disorder
Adial Pharmaceuticals Inc (NASDAQ:ADIL) has received notice from the FDA that its request for Fast Track Designation for AD04…
Sanofi – Regeneron’s Immunotherapy Scores European Approval For Skin And Lung Cancer Settings
The European Commission (EC) has approved Sanofi SA (NASDAQ:SNY) and Regeneron Pharmaceuticals Inc’s (NASDAQ:REGN) Libtayo (cemiplimab) for two additional indications – basal…
AbbVie Announces The FDA Informed Co. It Will Not Meet The PDUFA Action Date For The Supplemental NDA For RINVOQ
AbbVie (NYSE:ABBV) today announced that the U.S. Food and Drug Administration (FDA) has informed the company that the FDA will not meet the Prescription Drug User Fee Act (PDUFA) action dates for the supplemental New
FDA Gives Emergency Use Nod For Roche’s Arthritis Drug Against Severe COVID-19
The FDA has approved Roche Holding AG’s (OTC:RHHBY) arthritis drug Actemra (tocilizumab) for emergency use to treat adults and pediatric patients…
Jazz Pharmaceuticals Announces FDA Orphan Drug Exclusivity For Xywav Oral Solution
Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has recognized seven years of Orphan Drug Exclusivity for Xywav™ (calcium, magnesium, potassium, and sodium