Regulatory Approval

FDA clears Phase IIb trial for CS1, an epigenetic drug aiming to reverse PAH damage, not just manage symptoms, signaling a major market and patient shift.

New clinical data reveals a breakthrough 'off-the-shelf' cell therapy that could treat severe autoimmune diseases by re-engineering cellular identity.

A Houston biotech reports a 100% response rate with its new CAR-T therapy, offering a potential lifeline for patients with a devastatingly rare cancer.

EyeYon Medical's synthetic corneal implant, EndoArt, just got FDA approval for U.S. trials, offering a fix for the global donor tissue shortage.

Newron launches a pivotal US trial for its novel schizophrenia drug, evenamide, aiming to help millions who don't respond to current treatments.

New data on RAP-219 reveals more than just seizure control; it shows a strategic play to redefine treatment and capture the neurology market.

New clinical data on VALTOCO nasal spray shows significant benefits for young children, reinforcing the critical need for rapid seizure intervention.

A class action lawsuit against Telix Pharmaceuticals reveals the perilous gap between optimistic corporate disclosures and harsh regulatory setbacks.

A regulatory filing shows hedge fund Balyasny's active trading in Avadel Pharma, exposing a merger arbitrage strategy amid a fierce bidding war.