Browsing Tag
U.S. Food and Drug Administration
103 posts
Granules India gains key FDA approval for Unit V facility, marking major compliance milestone
Hyderabad-based Granules India Limited has achieved a significant regulatory milestone, securing an Establishment Inspection Report (EIR) with a…
Ionis Pharmaceuticals moves forward with FDA review of donidalorsen for HAE
In a significant development for hereditary angioedema (HAE) patients, Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced that the U.S.…
FDA approves Pfizer’s HYMPAVZI for breakthrough hemophilia treatment
In a major leap for hemophilia patients, Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug…
Hurricane Helene wreaks havoc! Baxter’s largest facility shuts down, putting U.S. medical supply at risk
In an unexpected and devastating turn of events, Hurricane Helene has forced Baxter International Inc. to shut down…
GE HealthCare receives FDA approval for Flyrcado PET radiotracer, set to transform coronary artery disease diagnosis
GE HealthCare has received the US Food and Drug Administration (FDA) approval for Flyrcado (flurpiridaz F-18), a breakthrough…
Organon to acquire Dermavant for $1.2bn, expanding its presence in immuno-dermatology
Organon, a global healthcare company focused on women’s health, has announced a definitive agreement to acquire Dermavant Sciences…
Theratechnologies faces critical disruption in EGRIFTA SV supply following FDA-induced factory shutdown
Theratechnologies Inc., a leading biopharmaceutical company based in Montreal, has announced a potentially significant disruption in the supply…
Athira Pharma stock nosedives after Alzheimer’s drug trial results disappoint
Athira Pharma’s stock plunged by 75% after the company announced that its Phase 2/3 LIFT-AD clinical trial for…
Could vimseltinib be the next big thing in TGCT treatment? FDA says Yes!
The U.S. Food and Drug Administration (FDA) has granted priority review status to Deciphera Pharmaceuticals, Inc.’s New Drug…
FDA extends review period for Humacyte’s vascular trauma treatment ATEV
The U.S. Food and Drug Administration’s review of Humacyte, Inc.’s innovative vascular trauma treatment, known as the acellular…