Browsing Tag
U.S. Food and Drug Administration
105 posts
AstraZeneca, Daiichi Sankyo score tenth BTD for Enhertu in early HER2 disease
AstraZeneca and Daiichi Sankyo’s Enhertu earns FDA breakthrough tag in early breast cancer. Find out what this means for HER2 treatment strategy in 2025.
Corcept Therapeutics (NASDAQ: CORT) plunges as FDA rejects relacorilant for Cushing’s-related hypertension therapy
Corcept shares nosedive after FDA rejection of relacorilant for Cushing’s syndrome-related hypertension. Find out what this means for the company’s future.
HAI Solutions receives FDA De Novo grant for QIKCAP: Is this UVC breakthrough the next standard in IV connector disinfection?
HAI Solutions secures FDA De Novo grant for its UVC-based QIKCAP System. Find out how this new category could change IV connector disinfection forever.
Glioblastoma trial for MT027 moves forward as T-MAXIMUM debuts allogeneic cell therapy in CNS
T-MAXIMUM wins FDA clearance for MT027 in glioblastoma. Read how its non-viral, off-the-shelf CAR-T may reshape solid tumor cell therapy development.
Can Rubraca really replace docetaxel in prostate cancer? FDA just said yes
Rubraca becomes first PARP inhibitor approved before chemo in BRCA+ prostate cancer. Find out how TRITON3 data is reshaping treatment strategy.
Lilly’s oral GLP-1 orforglipron sustains weight loss after injectables in pivotal Phase 3 trial
Lilly’s orforglipron helped patients maintain weight loss after injectable GLP-1s in a Phase 3 trial. Find out how this could reshape obesity treatment paths.
Will Novartis’ oral drug iptacopan change the game in myasthenia gravis treatment?
Novartis gains FDA orphan designation for iptacopan in myasthenia gravis. Explore how this oral drug could shift neurology and rare disease strategy.
FDA nod sends Organogenesis shares higher as ReNu eyes BLA filing for knee osteoarthritis pain
Find out how Organogenesis’ FDA alignment clears the path for a ReNu BLA filing in knee osteoarthritis pain and why investors are paying attention now.
FDA clears Amphastar Pharmaceuticals’ teriparatide injection, opening a new growth pathway in osteoporosis treatment
Find out how FDA approval of Amphastar Pharmaceuticals’ teriparatide injection opens a new growth pathway in the U.S. osteoporosis treatment market.
Milestone Pharmaceuticals (NASDAQ: MIST) gets FDA green light for etripamil nasal spray
Discover how Milestone Pharmaceuticals’ FDA approval of CARDAMYST (etripamil) is reshaping PSVT treatment and setting the stage for broader cardiovascular care. Read more.