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…
On Jun. 22, 2023, the U.S. Food and Drug Administration (FDA) approved Sarepta Therapeutics’s Elevidys, the first gene…
On Jun. 20, 2023, the U.S. Food and Drug Administration (FDA) approved Boehringer Ingelheim’s Jardiance (empagliflozin) and Synjardy…
On Jun. 16, 2023, the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee…
On Jun. 6, 2023, the U.S. Food and Drug Administration (FDA) granted granted marketing authorization for the Cue COVID-19…
On May 31, 2023, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved ABRYSVO (Respiratory…
On May 25, 2023, the U.S. Food and Drug Administration (FDA) approved the oral antiviral Paxlovid (nirmatrelvir tablets…
On May 24, 2023, the U.S. FDA approved Braeburn pharmaceutical’s Brixadi (buprenorphine) extended-release injection for subcutaneous use (under…
On May 18, 2023, the U.S. FDA approved approved Rinvoq (upadacitinib) for adults with moderately to severely active…
On May 11, 2023, the U.S. Food and Drug Administration (FDA) announced the supplemental approval of Otsuka Pharmaceutical…
On May 3, 2023, Washington State University (WSU) made history in the United States (US) by becoming the…
On May 3, 2023, Vertex announced the Food and Drug Administration (FDA) ha approved KALYDECOᆴ (ivacaftor) for use…
On May 3, 2023, the U.S. FDA approved GlaxoSmithKline’s Arexvy as the first respiratory syncytial virus (RSV) vaccine…
On May 2, 2023, the U.S. FDA announced that it was taking additional steps to support the use…
On Apr. 27, 2023, Pfizer announced that experimental respiratory syncytial virus (RSV) vaccine was 82% effective in preventing…
On Apr. 26, 2023, Vertex announced the Food and Drug Administration (FDA) had approved the expanded use of…
On Apr. 25, 2023, the U.S. FDA approved Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis (ALS)…
On Apr. 24, 2023, the U.S. Food and Drug Administration (FDA) authorized Status COVID-19 Antigen Rapid Test for…
On Apr. 17, 2023, the U.S. FDA approved Gamida Cell’s Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord…
On Apr. 14, 2023, Revance Therapeutics announced that the U.S. Food and Drug Administration (FDA) had approved the…
On Apr. 14, 2023, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the…
On Mar. 29, 2023, the U.S. Food and Drug Administration (FDA) announced approval of Narcan, 4 milligram naloxone…
On Mar. 10, 2023, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved ZAVZPRET (zavegepant),…
On Mar. 9, 2023, the U.S. Food and Drug Administration (FDA) announced that it had published updates to…
On Mar. 8, 2023, Amphastar Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) had granted approval…
On Mar. 8, 2023, QuidelOrtho announced that it had been granted a De Novo request from the U.S….
On Mar. 6, 2023, Merck announced that the U.S. Food and Drug Administration had approved the addition of…
On Mar. 6, 2023, Neuromod Devices announced that the US Food and Drug Administration (FDA) had granted De…
On Mar. 1, 2023, BioNTech and Pfizer announced that they had submitted an application to the U.S. Food…
On Feb. 13, 2023, Novavax announced a modification to its existing agreement with the U.S. Department of Health…
On Feb. 10, 2023, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for…