FDA granted Marketing Authorization of first test for chlamydia and gonorrhea with at-home sample collection
On Nov. 15, 2023, the U.S. Food and Drug Administration granted marketing authorization to LetsGetChecked for the Simple…
Biotechnology | COVID-19 | Diagnostics | FDA | Infectious Disease | NIH
FDA cleared first COVID-19 home antigen test
On Nov. 9, 2023, the U.S. Food and Drug Administration (FDA) cleared for marketing the first over-the-counter (OTC)…
Abbott received FDA approval for HPV test to run on Alinity m family of diagnostic assays
On Nov. 2, 2023, Abbott announced that it had received U.S. Food and Drug Administration (FDA) approval for…
FDA approved interchangeable biosimilar for multiple inflammatory diseases
On Oct. 31, 2023, the U.S. Food and Drug Administration (FDA) announced it had approved Amgen’s Wezlana (ustekinumab-auub)…
FDA approved Novartis Cosentyx as the first new biologic treatment for hidradenitis suppurativa patients in a decade
On Oct. 31, 2023, Novartis announced that the US Food and Drug Administration (FDA) had approved Cosentyxﾮ (secukinumab)…
FDA approved new therapy for rare form of blood cancers called myelodysplastic syndromes
On Oct. 24, 2023, the U.S. Food and Drug Administration approved Servier Pharmaceuticals’ Tibsovo (ivosidenib) for the treatment…
FDA approved PENBRAYA,the first and only vaccine for prevention of most common serogroups causing meningococcal
On Oct. 20, 2023, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved PENBRAYA (meningococcal…
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 (FDA) amended the emergency use authorization (EUA) of…
Biotechnology | CDC | COVID-19 | FDA | Infectious Disease | Vaccine
Novavax 2023-2024 COVID-19 Vaccine Authorized and Recommended for Use in the U.S.
On Oct. 3, 2023, Novavax announced that it’s COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) had received Emergency Use…
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…
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 | 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…
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…
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…