U.S. FDA approved second OTC Naloxone nasal spray product
On Jul. 28, 2023, the U.S. U.S. Food and Drug Administration (FDA) approved RiVive, 3 milligram (mg) naloxone…
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Emergent BioSolutions received U.S. FDA approval of CYFENDUS 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…
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U.S. FDA approved new drug to prevent RSV in babies and toddlers
On Jul. 17, 2023, the U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Beyfortus (nirsevimab-alip) for the prevention…
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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…
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Perrigo announced U.S. FDA approval for Opill OTC daily oral contraceptive
On Jul. 13, 2023, Perrigo announced that the U.S. Food and Drug Administration had approved Opill, a progestin-only…
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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…
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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…
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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…
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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…
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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…
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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…
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AquaBounty Announced a Pause to Ohio Farm Construction While It Evaluated Alternatives
On Jun. 2, 2023 AquaBounty Technologies announced that the Company will pause the construction of its farm in…
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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…
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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…
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U.S. FDA approved new buprenorphine treatment option for opioid use disorder
On Mar. 23, 2023, the U.S. Food and Drug Administration (FDA) approved Braeburn pharmaceutical’s Brixadi (buprenorphine) extended-release injection…
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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…
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FDA approved first oral treatment for moderately to severely active Crohn’s disease
On May 18, 2023, the U.S. Food and Drug Administration (FDA) approved approved Rinvoq (upadacitinib) for adults with moderately…
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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…
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FDA Approved 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…
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Vertex announced U.S. FDA approval for KALYDECO to treat eligible Infants with cystic 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) had approved KALYDECO (ivacaftor) for use…
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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…
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Biotechnology | Clinical Research | Diagnostics | FDA | Infectious Disease | NIH | Therapeutics | Vaccine | Women's Health
U.S. FDA announced additional steps to advance decentralized clinical trials
On May 2, 2023, the U.S. Food and Drug Administration (FDA) announced that it was taking additional steps…
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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 the U.S. Food and Drug Administration (FDA) has approved PREVNAR 20®…
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Biotechnology | Disease | FDA | Therapeutics
Vertex announced U.S. FDA approval for TRIKAFTA 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…
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U.S. FDA approved treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene
On Apr. 25, 2023, the U.S. U.S. Food and Drug Administration (FDA announced it had approved Qalsody (tofersen) to…
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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…
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Biotechnology | FDA | Oncology | Radiology | Stem Cell
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. Food and Drug Administration (FDA) approved Gamida Cell’s Omisirge (omidubicel-onlv), a substantially…
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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…
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FDA | Implants | Orthopedic
FDA authorizes marketing of MISHA Knee System for people Suffering from knee osteoarthritis
On Apr. 10, 2023, the U.S. Food and Drug Administration (FDA) authorized for marketing Moximed’s MISHA Knee System,…
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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…
