Browsing Tag
FDA approval
131 posts
CSL wins FDA approval for ANDEMBRY, the first monthly anti-factor XIIa therapy for hereditary angioedema
CSL’s ANDEMBRY gains U.S. FDA approval as the first monthly HAE treatment targeting factor XIIa. Learn how it redefines disease control for patients.
Unicycive (NASDAQ: UNCY) hit by FDA manufacturing concerns ahead of oxylanthanum carbonate decision
Unicycive’s NDA for oxylanthanum carbonate faces FDA manufacturing concerns. Key decision expected June 28. Read the stock outlook and next steps.
Tonix Pharmaceuticals stock up over 20%: Can TNX-102 SL and TNX-1700 fuel a turnaround in 2025?
Tonix Pharmaceuticals surged 21% despite deep losses, as retail traders bet on TNX-102 SL’s FDA nod and cancer pipeline momentum. Read the full story.
Glenmark Pharmaceuticals expands U.S. OTC market presence with Olopatadine Eye Drops
Glenmark secures FDA approval for its OTC Olopatadine Hydrochloride eye drops, expanding its U.S. presence in the $50.7M allergy relief market.
Novartis wins FDA approval for Fabhalta, the first treatment for C3 glomerulopathy
Novartis secures FDA approval for Fabhalta, the first-ever treatment for C3G. Find out how this breakthrough impacts patients and investors.
Game-changer for diabetes? Tandem’s Control-IQ+ automated insulin delivery system now available in the US
Tandem Diabetes Care launches Control-IQ+ automated insulin delivery for type 1 and type 2 diabetes, expanding access to advanced insulin automation in the U.S.
RedHill Biopharma secures $60m licensing agreement with Hyloris for global commercialization of RHB-102
RedHill Biopharma Ltd. has entered into an exclusive licensing agreement with Hyloris Pharmaceuticals SA, granting the Belgian company…
MeiraGTx’s gene therapy trial shows transformative results for children with LCA4 retinal dystrophy
MeiraGTx Holdings plc has announced groundbreaking results from its gene therapy trial targeting Leber congenital amaurosis 4 (LCA4),…
Vertex secures FDA approval for non-opioid pain treatment JOURNAVX
Vertex Pharmaceuticals Incorporated has achieved a significant milestone in the field of pain management with the FDA approval…
Mesoblast issues shares to Osiris Therapeutics after FDA approval of Ryoncil
Mesoblast Limited, a pioneering biotechnology company listed on the Australian Securities Exchange (ASX:MSB), has announced the issuance of…