Browsing Tag
U.S. Food and Drug Administration
103 posts
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.
Johnson & Johnson expands AKEEGA’s reach with FDA nod in BRCA2-mutated metastatic castration-sensitive prostate cancer
Johnson & Johnson’s AKEEGA secures FDA approval for BRCA2-mutated prostate cancer, reshaping early-stage treatment and signaling a shift toward genomic-first therapy.
At-home 12-lead ECG now a reality after FDA greenlights HeartBeam’s cable-free technology
Discover how HeartBeam’s FDA-cleared cable-free 12-lead ECG brings hospital-grade heart monitoring into homes and what it means for patients and investors.