Browsing Tag
U.S. FDA
23 posts
A $260.7m COPD market is opening up. Can Lupin Limited (NSE: LUPIN) turn approval into revenue?
A COPD generic opens a $260.7M U.S. door for Lupin Limited. The bigger test is launch timing, competition, and margin discipline.
Cipla and Orbicular bring first generic liraglutide for obesity to U.S. market, targeting $127m opportunity
Cipla launches generic Saxenda (liraglutide) in the U.S. via partner Orbicular's FDA approval. What this means for GLP-1 generics competition, payers, and Cipla's peptide strategy. Read more.
Haemonetics (NYSE: HAE) acquires Vivasure Medical in €185m deal to expand vascular closure portfolio for structural heart procedures
Haemonetics acquires Vivasure Medical to expand its hospital closure portfolio with PerQseal Elite. Find out what this means for structural heart growth.
FDA clears GenEditBio to begin human testing of GEB-101, a first-in-class genome-editing therapy for TGFBI corneal dystrophy
Find out how GenEditBio's GEB-101 genome-editing therapy just cleared FDA to begin trials for TGFBI corneal dystrophy. Could it redefine in vivo editing?
Celltrion’s Eydenzelt gets FDA nod — Is Eylea finally facing a real biosimilar rival?
Find out how Celltrion’s FDA-approved Eydenzelt is set to challenge Eylea and reshape the biosimilar landscape for retinal diseases in 2025.
Rubicon Research IPO: Can General Atlantic’s Rs 1,377cr exit test pharma market appetite?
Rubicon Research’s ₹1,377 crore IPO opens Oct 9. Backed by General Atlantic, can this pharma play sustain growth and deliver listing gains?
AbbVie seeks FDA approval for tavapadon to improve motor control in Parkinson’s disease patients
AbbVie (NYSE: ABBV) files FDA application for tavapadon, a once-daily oral Parkinson’s treatment aiming to improve motor control and expand its neuroscience pipeline.
Lupin Limited (NSE: LUPIN) gains on dual U.S. approvals for nasal spray and ophthalmic gel
Lupin Limited gains on U.S. nasal spray launch and FDA approval for ophthalmic gel. Find out how this could reshape its U.S. generics growth strategy.
What is HARLIKU and how will Cycle’s FDA-approved AKU drug help patients starting July 2025?
Cycle Pharmaceuticals secures FDA approval for HARLIKU™, the first approved treatment for alkaptonuria (AKU); launch in the U.S. expected July 2025.
Why has ovarian cancer eluded early screening success—and what’s changing now?
Ovarian cancer screening has failed for decades—now new tests like exosome and cfDNA panels are finally changing the story. Find out what’s driving the shift.