Browsing Tag
United States Food and Drug Administration
135 posts
TNX-103 Phase 3 failure forces Tenax into FDA reset after nearly 90% stock plunge
TNX-103 misses Phase 3 as Tenax shares crash nearly 90%. A 26.3-meter subgroup benefit now drives the company’s FDA rescue strategy.
Glaucoma drug NCX 470 reaches another major market as Nicox’s partner strategy pays off
NCX 470 enters China review as Nicox targets glaucoma royalties across China, the U.S. and Japan. See what the filing means for growth.
Can Ascendis Pharma turn two weekly injections into its next rare-disease growth engine?
Ascendis Pharma’s weekly achondroplasia combination sustains 7.7cm growth as YUVIWEL uptake builds. Read what it means for the franchise.
Platelet biomarker could shape bezisterim Phase 3 strategy after mixed investor response
Bezisterim shows broad Parkinson’s improvements, but BioVie’s stock plunge and cash needs raise doubts. Read the full Phase 2 analysis.
What the FDA authorization of Elanco CLiK Extra means for the New World screwworm response
FDA authorizes Elanco CLiK Extra for New World screwworm prevention. See its species coverage, evidence, restrictions and outbreak role.
Avacta (AIM: AVCT) share count rises 27.7% as £41.5m funding cycle splits between trials and debt
Avacta Group Plc has added approximately 102.3 million ordinary shares since the end of 2024, reducing a non-participating holder’s proportional ownership by about 21.7% while financing clinical development and lowering convertible-bond principal.
ResMed (ASX: RMD) drops 8% as Astral recall clouds FY27 outlook
ResMed fell 8% as FY27 sales guidance missed expectations. Astral recall costs and slower growth now test the ASX: RMD valuation.
Lexeo’s second cardiac gene therapy gains FDA support ahead of year-end update
LX2020 gains FDA RMAT status after early heart gene therapy data, strengthening Lexeo’s regulatory path ahead of a key 12-month update.
Early lung cancer responses push ACR-2316 into a broader randomized trial
ACR-2316 enters randomized expansion after durable lung cancer activity. Read how the six-tumor study could reshape Acrivon’s outlook.
One-time gene correction therapy BEAM-302 reaches pivotal AATD testing
BEAM-302 enters pivotal AATD testing as Beam Therapeutics targets accelerated approval with $1.2 billion in cash and new data due in September.