FDA updated COVID-19 Vaccines for Use in the U.S. Beginning in Fall 2024
On June 5, 2024, the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee announced that it had…
On June 5, 2024, the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee announced that it had…
On May 31, 2024, Moderna announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345),…
On May 14, 2024, Roche announced the U.S. FDA approval of its human papillomavirus (HPV) self-collection solution, one…
On Apr. 26, 2024, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved BEQVEZâ„¢ (fidanacogene…
On Apr. 10, 2024, LabCorp announced announced that the U.S. Food and Drug Administration (FDA) had granted Emergency…
On Apr. 1, 2024, Otsuka Pharmaceutica and Click Therapeutics announced that the U.S. Food and Drug Administration (FDA)…
On Mar. 26, 2024, Roche announced that the U.S. Food and Drug Administration (FDA) had approved the cobasï¾®…
On Mar. 22, 2024, the U.S. Food and Drug Administration the FDA issued an emergency use authorization for…
On Mar. 21, 2024, the U.S. Food and Drug Administration (FDA) approved Italfarmaco’s Duvyzat (givinostat) oral medication for…
On Mar. 18, 2024, the U.S. Food and Drug Administration approved Orchard Therapeutics’ Lenmeldy (atidarsagene autotemcel), the first…
On Mar. 8, 2024, the U.S. Food and Drug Administration approved a new indication for use of Novo…
On Mar. 4, 2024, Hugel America announced it received U.S. Food and Drug Administration (FDA) approval on its…
On Feb. 28, 2024, the U.S. Food and Drug Administration (FDA) announced that grease-proofing materials containing per- and…
On Feb. 16. 2024, Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Xolair…
On Jan. 16, 2024, the U.S. Food and Drug Administration (FDA) announced it had approved CRISPR Therapeutics’ CASGEVY…
On Jan. 15, 2024, CSL announced that Swissmedic had authorised HEMGENIX® (etranacogene dezaparvovec), the first and currently only gene…
On Jan. 5, 2024, the U.S. Food and Drug Administration authorized Florida’s Agency for Health Care Administration’s drug…
On Dec. 19, 2023, the U.S. Food and Drug Administration approved the first test that uses DNA in…
On Dec. 8, 2023, Vertex Pharmaceuticals and CRISPR Therapeutics announced that the U.S. Food and Drug Administration (FDA)…
On Dec. 8, 2023, bluebird bio announced the U.S. commercial launch of its LYFGENIA’ (lovotibeglogene autotemcel, also known…
On Dec. 5, 2023, Novartis announced that the U.S. Food and Drug Administration (FDA) had approved Fabhaltaï¾® (iptacopan)…
On Nov. 28, 2023, Emergent BioSolutions announced that the Biomedical Advanced Research and Development Authority (BARDA) within the…
On Nov. 22, 2023, the U.S. Food and Drug Administration issued the final guidance COVID-19: Developing Drugs and…
On Nov. 17, 2023, Masimo announced that the Masimo W1 medical watch has received FDA 510(k) clearance for…
On Nov. 15, 2023, the U.S. Food and Drug Administration granted marketing authorization to LetsGetChecked for the Simple…
On Nov. 9, 2023, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) antigen…
On Nov. 2, 2023, Abbott announced that it had received U.S. Food and Drug Administration (FDA) approval for…
On Oct. 31, 2023, Novartis announced that the US Food and Drug Administration (FDA) had approved Cosentyxï¾® (secukinumab)…
On Oct. 24, 2023, the U.S. Food and Drug Administration approved Servier Pharmaceuticals’ Tibsovo (ivosidenib) for the treatment…
On Oct. 20, 2023, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved PENBRAYA (meningococcal…