FDA approves Bayer’s Finerenone for new indication in patients with HF and LVEF of ?40%

Finerenone significantly reduced the combined risk of cardiovascular death and total (first and recurrent) heart failure events,

Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy

Capricor’s BLA for Deramiocel received Priority Review in March 2025

Panacea Biotec reaches settlement with Apotex

Apotex will also pay US$ 2.5 million upon receipt of final USFDA approval of the ANDA that is the subject of the Collaboration Agreement for Paclitaxel Protein-Bound Particles for Injectable Suspension

Briefs: Emcure Pharmaceuticals and Gland Pharma

Emcure Pharmaceuticals successfully completes USFDA PAI of Oncology facility

FDA approves Bravecto Quantum from Merck Animal Health

Pfizer and Astellas' Xtandi combo extends survival in early prostate cancer setting

Xtandi is approved in over 80 countries, including the U.S., EU, and Japan

Novo Nordisk submits application to EMA for higher dose of Wegovy for obesity treatment

The submission is based on data from the STEP UP and STEP UP T2D clinical trials

OneSource Specialty Pharma appoints Jeffrey Wong as CBO

He has held senior leadership positions at Syngene International, Fujifilm Diosynth Biotechnologies, Thermo Fisher Scientific, Sartorius Stedim Biotech, and other leading organizations

Veerhealth Care enters into contract manufacturing agreement

Commercial production is expected to begin soon

Imfinzi approved in the EU as first and only perioperative immunotherapy for muscle-invasive bladder cancer

Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen vs. neoadjuvant chemotherapy alone