The FDA has delayed NASP without raising clinical approvability concerns, shifting attention to manufacturing controls, contract facilities and Sobi’s resubmission strategy.
Larimar’s rolling BLA submission and long-term nomlabofusp data strengthen the case for a potential disease-modifying Friedreich’s ataxia therapy.
The FDA approval brings CDK4/6 inhibition into HR-positive, HER2-positive metastatic breast cancer maintenance, although toxicity, immature survival data and a rapidly changing first-line market could shape adoption.
FDA approval brings BESREMi Pen to U.S. polycythemia vera care. Find out how convenience, safety and access may shape adoption.
See how VeriSIM Life’s FDA/NCTR research collaboration could shape transparent mechanistic AI for safer, faster drug development.
Cognition Therapeutics’ FDA alignment gives zervimesine a clearer pivotal path in dementia with Lewy bodies psychosis, a high-need disorder with no approved therapy
Discover whether IceCure’s 70% ProSense installation growth can turn breast cryoablation into a scalable alternative to surgery.
Discover how Sanofi’s Tzield approval could reshape newly diagnosed pediatric type 1 diabetes care and why major clinical questions remain.
Explore why the FDA reopened uniQure’s AMT-130 approval path and what evidence, surgical and confirmatory trial risks remain before review.
Read how Corcept’s relacorilant NDA resubmission could reshape Cushing’s treatment while efficacy and liver safety questions remain.