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

FDA go-ahead to Roche’s one-minute follicular lymphoma therapy

Full approval will depend on verification of clinical benefit in a confirmatory trial

Novo Nordisk’s Wegovy pill approved in US as first oral GLP-1 for weight management

Wegovy pill showed a mean weight loss of 16.6% in the OASIS 4 trial

China approves first-in-class TGCT drug, marking global first for pimicotinib

CORONA Remedies commissions additional capacity

The additional production will raise the installed capacity by 400 million and available capacity by 240 million at the facility

Care ADHD opens its first Global Capability Centre in India

UK headquartered digital health scale-up strengthens global tech and innovation footprint in the country

Granules receives FDA tentative approval for generic Amphetamine ER orally disintegrating tablets

Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia

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

Briefs: APL Healthcare, Biocon, USFDA, Sun Pharma and Clean Fino-Chem

USFDA determines Sun Pharma's Baska facility inspection classification as OAI

SandboxAQ, MapLight team up to target novel CNS therapy with AI-driven drug discovery

SandboxAQ will receive an upfront payment and could earn up to $200 million in milestone payments tied to preclinical, development, regulatory, and commercial achievements