FDA authorized updated Novavax COVID-19 vaccine formulated to better protect against currently circulating variant
On Oct. 3, 2023, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the…
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…
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…
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…
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…
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…
Biotechnology | COVID-19 | FDA | Life Science News | 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 confirm its updated COVID-19…
Biotechnology | Diagnostics | Disease | FDA | Life Science News | 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…
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…
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 Vekluryﾮ (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 LEQEMBIﾮ (lecanemab-irmb) for the treatment of Alzheimerﾒ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 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 | 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 Crohnﾒ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 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…