FDA grants breakthrough therapy designation to Enhertu for high-risk early breast cancer

This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care

Abbott wins FDA & CE nod for groundbreaking premature infant heart device

The system is intended for some of the tiniest patients—premature infants weighing as little as two pounds

Qihan Biotech launches first-in-human trial of off-the-shelf CAR-T therapy for refractory lupus

The study is being conducted under a USFDA IND, has received U.S. Fast Track Designation for SLE-ITP, and has obtained IND approval from China’s Center for Drug Evaluation

Cosette Pharmaceuticals launches first generic CIPRO HC with 180 Days market exclusivity

The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,

Minghui Pharmaceutical gets FDA green light for Phase III trials of its therapy in thyroid eye disease

The upcoming trials will evaluate both active and chronic TED in randomized, double-blind, placebo-controlled studies

Sanofi flags delay in FDA review of Tolebrutinib for progressive multiple sclerosis

FDA completes inspection of SMS Pharma’s Vizag facility

The inspection concluded with one minor observation in Form 483

GSK’s experimental lung cancer drug gains FDA orphan drug status

GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization

FDA nods spotlight precision oncology platforms as market surges towards $212 billion by 2034

The U.S. oncology market is projected to soar from $81 billion in 2025 to $212 billion by 2034

Zydus and Formycon secure US and Canada partnership for Keytruda biosimilar

Formycon AG will develop, register, manufacture and supply the product, while Zydus Lifesciences Global FZE, United Arab Emirates will be responsible for the commercialization of FYB206 in the defined territories