FDA launched pilot program to help further accelerate development of rare disease therapies
On Sept. 29, 2023, the U.S. Food and Drug Administration announced it was taking steps to help further…
-
-
FDA granted first marketing authorization for DNA test to assess predisposition for dozens of cancer types
On Sept. 29, 2023, the U.S. Food and Drug Administration (FDA) granted Invitae de novo marketing authorization for…
-
Amicus Therapeutics announced FDA approval and launch of treatment for Pompe disease
On Sept. 28, 2023, Amicus Therapeutics announced that the U.S. Food and Drug Administration (FDA) had approved Pombilitiﾙ…
-
Agriculture | Biotechnology | FDA | USDA
APHIS issued regulatory status review response for Ohalo Genetics potato
On Sept. 26, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced…
-
Pfizer and BioNTech received U.S. FDA approval for 2023-2024 COVID-19 vaccine
On Sept. 11, 2023, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) approved the…
-
Moderna received U.S. FDA approval for updated COVID-19 vaccine
On Sept. 11, 2023, Moderna announced the U.S. Food and Drug Administration (FDA) had approved the supplemental Biologics…
-
Biotechnology | COVID-19 | FDA | Vaccine
Moderna clinical trial data confirmed updated Covid-19 vaccine generated strong immune response against BA.2.86 variant
On Sept. 6, 2023, Moderna announced that clinical trial data from its research assay confirmed its updated COVID-19…
-
Biotechnology | Diagnostics | Disease | FDA | Oncology | Radiology | Therapeutics | Women's Health
FDA Cleared 23andMe improved BRCA report for communities underrepresented in genetic testing
On Aug. 31, 2023, the U.S. Food and Drug Administration (FDA) cleared for marketing the updated 23andMe Personal…
-
COVID-19 | FDA | Infectious Disease | Vaccine
Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron XBB.1.5-adapted COVID-19 Vaccine in the European Union
On Aug. 30, 2023, Pfizer and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP)…
-
Aspirin can help prevent a second heart attack, but most don’t take it
On Aug. 22, 2023, a study led by researchers at Washington University School of Medicine in St. Louis…
-
U.S. FDA approved ABRYSVO, Pfizer’s vaccine for prevention of RSV in infants through active immunization of pregnant Individuals
On Aug. 21, 2023, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved ABRYSVO (Respiratory…
-
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…
-
Emergent BioSolutions awarded 10-Year BARDA contract valued at $704 million for Ebanga treatment for Ebola
On Jul. 31, 2023, Emergent BioSolutions announced that it was awarded a 10-year contract by the Biomedical Advanced…
-
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…
-
U.S. FDA approved Ervebo first U.S.-licensed vaccine for prevention of Ebola virus disease
On Dec. 20, 2019, Merck announced that the U.S. Food and Drug Administration (FDA) had approved ERVEBO® (Ebola…
-
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…
-
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…
-
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…
-
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 Mar. 23, 2023, the U.S. Food and Drug Administration (FDA) approved Braeburn pharmaceutical’s Brixadi (buprenorphine) extended-release injection…
-
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…
