25/03/2026 Corcept's relacorilant + nab-paclitaxel received FDA approval for platinum-resistant Ovarian Cancer TRIANA Biomedicines' TRI-611 received the FDA fast track designation for ALK+ NSCLC In a $6.7B deal, Merck & Co acquired Terns Pharmaceuticals to expand its hematology pipeline Corcept's relacorilant + nab-paclitaxel received FDA approval for platinum-resistant Ovarian Cancer (Ref) The US FDA granted approval to Corcept Therapeutics Incorporated's Lifyorli (relacori

26/01/2026 Cogent Biosciences' bezuclastinib + sunitinib received the FDA Breakthrough Therapy Designation for GIST Innovent Biologics' IBI3003 received the FDA Fast Track Designation for multiple myeloma Cogent Biosciences' bezuclastinib + sunitinib received the FDA Breakthrough Therapy Designation for GIST (Ref) The US FDA granted the Breakthrough Therapy Designation to Cogent Biosciences' bezuclastinib (tyrosine kinase inhibitor) in combination with sunitinib for patients

06/01/2026 Cellenkos' CK0804 received the FDA orphan drug designation for myelofibrosis Bayer's sevabertinib received the breakthrough therapy designation for HER2-mutant NSCLC Cellenkos' CK0804 received the FDA orphan drug designation for myelofibrosis (Ref) The US FDA granted the orphan drug designation to Cellenkos' CK0804 (CXCR4hi Treg therapeutic) for treatment of myelofibrosis. Dr. Simrit Parmar, MD, Founder, Cellenkos: "Receiving Orphan Drug Designation is an important

June 4th Week,2025 Regulatory Events 🎯 Daiichi Sankyo and AstraZeneca's Dato-DXd (Datroway; TROP2 ADC) has been granted an accelerated approval by the US FDA for the Tx of EGFR+ NSCLC patients previously treated with EGFR directed therapy and platinum-based chemotherapy. (Ref 1) ❓ Which other key regimens are expected to enter this setting in the near future? Special Designations ⭐ enGene's detalimogene voraplasmid (non-viral gene therapy) was granted a Regenerative Medici