Biotechnology | FDA | Vaccine
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 CYFENDUSﾙ 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 CYFENDUSﾙ…
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 Veklury (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…
Biotechnology | Disease | FDA | Neurology | Therapeutics
FDA granted traditional approval for LEQEMBI (lecanemab-irmb) for the treatment of Alzheimer’s disease
On Jul. 6, 2023, Eisai and Biogen announced that the U.S. Food and Drug Administration (FDA) had approved the…
Biotechnology | Diagnostics | Disease | FDA | Rare Disease | Therapeutics
U.S. FDA approved BioMarin’s ROCTAVIAN, the first and only gene therapy for adults with severe hemophilia A
On Jun. 29, 2023, the U.S. Food and Drug Administration approved Roctavian, an adeno-associated virus vector-based gene therapy…
AquaBounty Announced a Pause to Ohio Farm Construction While It Evaluated Alternatives
On Jun. 22, 2023 AquaBounty Technologies announced that the Company will pause the construction of its farm in…
Biotechnology | Disease | FDA | 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. Food and Drug Administration (FDA) granted granted marketing authorization for the Cue COVID-19…
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. Food and Drug Administration (FDA) approved the oral antiviral Paxlovid (nirmatrelvir 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 Clears New Insulin Pump and Algorithm-Based Software to Support Enhanced Automatic Insulin Delivery
On May 19, 2023, the U.S. Food and Drug Administration (FDA) cleared the Beta Bionics iLet ACE Pump…
FDA approved first oral treatment for moderately to severely active Crohnﾒs disease
On May 18, 2023, the U.S. FDA approved approved Rinvoq (upadacitinib) for adults with moderately to severely active…
Biotechnology | Disease | FDA | Neurology | Therapeutics
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…
US FDA Says Yes to First University-made Sausage from Gene-edited Pigs
On May 3, 2023, Washington State University (WSU) made history in the United States (US) by becoming the…
Vertex announced U.S. FDA approval for KALYDECOﾮ 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 KALYDECOﾮ (ivacaftor) for use…
Biotechnology | FDA | Therapeutics | Vaccine
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…
Biotechnology | FDA | Therapeutics | Vaccine
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 TRIKAFTAﾮ 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. Food and Drug Administration (FDA) authorized Status COVID-19 Antigen Rapid Test for…
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. Food and Drug Administration (FDA) issued an emergency use authorization for the…
U.S. FDA approved first Over-the-Counter Naloxone nasal spray
On Mar. 29, 2023, the U.S. Food and Drug Administration (FDA) announced approval of Narcan, 4 milligram naloxone…