LAW
FDA Approves BrainStorm’s Phase IIIb Trial Design for NurOwn in Early-Stage ALS
BrainStorm Cell Therapeutics, NurOwn, Phase IIIb trial, Special Protocol Assessment (SPA), FDA agreement, Early-stage ALS, Amyotrophic Lateral Sclerosis (ALS)
Eiger BioPharmaceuticals Declares Bankruptcy and Announces Operational Wind Down Following Years of Challenges
Eiger BioPharmaceuticals, Bankruptcy, Chapter 11, Assets Sale, Operational Wind Down, Rare Metabolic Disease Therapy Development
Bristol Myers Squibb’s KRAZATI Confirmed Effective in Pivotal Phase 3 KRYSTAL-12 Trial Following Accelerated Approval
Bristol Myers Squibb, KRAZATI (adagrasib), Pivotal Phase 3 trial, KRYSTAL-12 study, Primary endpoint met, Progression-free survival (PFS), Overall response rate (ORR), Confirmatory trial, Non-small cell lung cancer (NSCLC), Locally advanced or metastatic, KRASG12C mutation, Accelerated approval, Continued approval contingent on clinical benefit verification, FDA assigned PDUFA goal date of June 21/ 2024