Astellas’ Menopause Drug Sores FDA Approval, After Regulatory Setback
The FDA on Friday approved Japanese drugmaker Astellas Pharma Inc’s (OTC: ALPMY) (OTC: ALPMF) Veozah (fezolinetant) for hot flashes
FDA AdComm Narrowly Supports Approval Of Sarepta’s Gene Therapy For Rare Neuromuscular Disorder
On Friday, FDA's Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) voted 8 to 6 in support of accelerated approval of Sarepta Therapeutics Inc's (NASDAQ: SRPT) SRP-9001 (delandistrogene moxeparvovec) for ambulatory patients with
Why ARS Pharmaceuticals Stock Is Soaring Today
The FDA's Pulmonary-Allergy Drug Advisory Committee voted 16-6 in favor of ARS Pharmaceuticals Inc's (NASDAQ: SPRY) neffy in treating severe allergic reactions for adults (and 16-5 for
Stock Loses 50% In One Trading Session – Why Are ImmunityBio Shares Tanking Today?
The FDA has issued a complete response letter to ImmunityBio Inc's (NASDAQ: IBRX) Anktiva (N-803), in combination with Bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS) with or without Ta or T1 disease.
Japan’s Otsuka Pharma-Lundbeck Partnered Depression Drug Gets FDA Approval For Alzheimer’s Agitation
Otsuka Pharmaceutical Co Ltd (OTC: OTSKF) (OTC: OTSKY) (Otsuka) and H.
Canalevia-CA1, Jaguar Animal Health’s FDA Conditionally Approved Drug For Chemotherapy-Induced Diarrhea In Dogs, Now Available From Chewy
Canalevia®-CA1 is the first and only treatment for CID in dogs to receive any type of approval from the FDA
SAN FRANCISCO, CA / ACCESSWIRE / May 11, 2023 / Jaguar Health, Inc. (NASDAQ:JAGX)
FDA Staff Raises Issues For Sarepta’s Duchenne Gene Therapy Data, Analyst Says Issues Known, Expects Positive Vote
The FDA's Cellular, Tissue and Gene Therapies Advisory Committee is meeting this Friday to discuss Sarepta Therapeutics Inc's (NASDAQ: SRPT) to review SRP-9001 (delandistrogene moxeparvovec), investigational gene therapy for
Fabry Disease Treatment Showdown: Protalix Bio’s Elfabrio Joins the Ranks of Sanofi and Amicus Therapeutics
The FDA approved Chiesi Group and Protalix BioTherapeutics Inc's (NASDAQ: PLX) Elfabrio (pegunigalsidase alfa-iwxj) for treating adult
Minerva Neurosciences Announces FDA Acceptance Of The Filing Of The NDA For Roluperidone For The Treatment Of Negative Symptoms In Schizophrenia
FDA confirms acceptance of the filing of the NDA for roluperidone
Application has been granted a standard review
FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 26,