Browsing Tag
U.S. Food and Drug Administration
166 posts
Vanda Pharmaceuticals’ VGT-1849A gets orphan drug designation for polycythemia vera treatment
Vanda Pharmaceuticals Inc. has achieved a critical regulatory milestone with the U.S. Food and Drug Administration (FDA) granting…
Medtronic receives FDA clearance for innovative Smart MDI system with Simplera CGM integration
Medtronic plc has received U.S. Food and Drug Administration (FDA) clearance for its innovative Smart Multiple Daily Injection…
FDA accepts Bayer’s application to expand NUBEQA’s use in prostate cancer treatment
The U.S. Food and Drug Administration (FDA) has accepted Bayer’s supplemental new drug application (sNDA) for NUBEQA (darolutamide),…
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…