U.S. FDA approved ZURZUVAE (zuranolone), the First and only oral treatment for Women with postpartum depression
On Aug. 4, 2023, Biogen and Sage Therapeutics announced that the U.S. Food and Drug Administration (FDA) had…
U.S. FDA approved Merck’s ERVEBO (Ebola Zaire Vaccine, Live) for use in children 12 months of age and older
On Aug. 3, 2023, Merck announced that the U.S. Food and Drug Administration (FDA) had approved an expanded…
U.S. FDA approved Ervebo first U.S.-licensed vaccine for prevention of Ebola virus disease
On Jul. 28, 2023, the U.S. Food and Drug Administration (FDA) approved Merck’s Ervebo, a vaccine for the…
U.S. FDA approved second OTC Naloxone nasal spray product
On Jul. 28, 2023, the U.S. FDA approved RiVive, 3 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter…
Emergent BioSolutions received U.S. FDA approval of CYFENDUSï¾™ Anthrax vaccine for post-exposure prophylaxis use
On Jul. 20, 2023, Emergent BioSolutions announced that the U.S. Food and Drug Administration (FDA) had approved CYFENDUSï¾™…
U.S. FDA approved new drug to prevent RSV in babies and toddlers
On Jul. 17, 2023, the FDA approved AstraZeneca’s Beyfortus (nirsevimab-alip) for the prevention of Respiratory Syncytial Virus (RSV)…
U.S. FDA approved Vekluryï¾® (Remdesivir) for COVID-19 treatment in patients with Severe renal impairment
On Jul. 14, 2023, Gilead Sciences announced that the U.S. Food and Drug Administration (FDA) had approved a…
FDA granted traditional approval for LEQEMBIï¾® (lecanemab-irmb) for the treatment of Alzheimerï¾’s disease
On Jul. 6, 2023, Eisai and Biogen announced that the U.S. Food and Drug Administration (FDA) has approved…
U.S. FDA approved BioMarin’s ROCTAVIANï¾™, the first and only gene therapy for adults with severe hemophilia A
On Jun. 29, 2023, BioMarin Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) approved ROCTAVIANï¾™ (valoctocogene…
Biotechnology | Disease | FDA | Life Science News | Medicine | Therapeutics
U.S. FDA approved first gene therapy for treatment of patients with Duchenne Muscular Dystrophy
On Jun. 22, 2023, the U.S. Food and Drug Administration (FDA) approved Sarepta Therapeutics’s Elevidys, the first gene…
U.S. FDA approved new class of medicines to treat pediatric type 2 diabetes
On Jun. 20, 2023, the U.S. Food and Drug Administration (FDA) approved Boehringer Ingelheim’s Jardiance (empagliflozin) and Synjardy…
U.S. FDA updated COVID-19 vaccines for use in the U.S. beginning in Fall 2023
On Jun. 16, 2023, the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee…
U.S. FDA permitted marketing of first COVID-19 at-home test using traditional premarket review process
On Jun. 6, 2023, the U.S. FDA granted granted marketing authorization for the Cue COVID-19 Molecular Test. The…
Disease | FDA | Pharmaceutical | Therapeutics | Vaccine
U.S. FDA approved ABRYSVO, Pfizer’s vaccine for prevention of RSV in older adults
On May 31, 2023, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved ABRYSVO (Respiratory…
U.S. FDA approved Paxlovid, first oral antiviral for treatment of COVID-19 in adults
On May 25, 2023, the U.S. FDA approved approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets,…
U.S. FDA approved new buprenorphine treatment option for opioid use disorder
On May 24, 2023, the U.S. FDA approved Braeburn pharmaceutical’s Brixadi (buprenorphine) extended-release injection for subcutaneous use (under…
FDA approved first oral treatment for moderately to severely active Crohnï¾’s disease
On May 18, 2023, the U.S. FDA approved approved Rinvoq (upadacitinib) for adults with moderately to severely active…
FDA approved first drug to treat agitation symptoms associated with dementia due to Alzheimer’s disease
On May 11, 2023, the U.S. Food and Drug Administration (FDA) announced the supplemental approval of Otsuka Pharmaceutical…
Vertex announced U.S. FDA approval for KALYDECOï¾® to treat eligible Infants withcystic fibrosis ages 1 month and older -First and only CFTR modulator approved for this age group-
On May 3, 2023, Vertex announced the Food and Drug Administration (FDA) ha approved KALYDECOï¾® (ivacaftor) for use…
U.S. FDA approved first Respiratory Syncytial Virus (RSV) vaccine
On May 3, 2023, the U.S. FDA approved GlaxoSmithKline’s Arexvy as the first respiratory syncytial virus (RSV) vaccine…
U.S. FDA announced additional steps to advance decentralized clinical trials
On May 2, 2023, the U.S. FDA announced that it was taking additional steps to support the use…
U.S. FDA approved PREVNAR 20, Pfizer’s 20-valent pneumococcal conjugate vaccine for infants and children
On Apr. 27, 2023, Pfizer announced that experimental respiratory syncytial virus (RSV) vaccine was 82% effective in preventing…
Vertex announced U.S. FDA approval for TRIKAFTAï¾® in children with cystic fibrosis ages 2 through 5 with certain mutations
On Apr. 26, 2023, Vertex announced the Food and Drug Administration (FDA) had approved the expanded use of…
U.S. FDA approved treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene
On Apr. 25, 2023, the U.S. FDA approved Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis (ALS)…
U.S. FDA issued Emergency Use Authorization for new COVID-19 Over-the-Counter at-home antigen test
On Apr. 24, 2023, the U.S. FDA authorized Status COVID-19 Antigen Rapid Test for Home Use (manufactured by…
U.S. FDA approves cell therapy for patients with blood cancers to reduce risk of infection after stem cell transplantation
On Apr. 17, 2023, the U.S. FDA approved Gamida Cell’s Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord…
U.S. FDA Approved First Therapeutic Indication for Revance’s DAXXIFY® (DaxibotulinumtoxinA-lanm) for the Treatment of Cervical Dystonia
On Apr. 14, 2023, Revance Therapeutics announced that the U.S. Food and Drug Administration (FDA) had approved the…
U.S. FDA issued EUA for new COVID-19 over-the-counter at-home antigen test
On Apr. 14, 2023, the U.S. FDA issued an emergency use authorization for the Azure Fastep COVID-19 Antigen…
U.S. FDA approved first Over-the-Counter Naloxone nasal spray
On Mar. 29, 2023, the U.S. FDA announced approval of Narcan, 4 milligram naloxone hydrochloride nasal spray for…
Pfizer’s ZAVZPRET (zavegepant) Migraine Nasal Spray received FDA approval
On Mar. 10, 2023, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved ZAVZPRET (zavegepant),…