Solara’s Mangalore facility clears FDA inspection with VAI status

Innovent Biologics’ experimental weight-loss drug achieves breakthrough in Phase 3 trial

Innovent plans to soon submit a new drug application (NDA) to China’s National Medical Products Administration

Galmed’s Aramchol shows promise in overcoming gastrointestinal cancer drug resistance

Stivarga is the standard third-line treatment for metastatic colorectal cancer, gastrointestinal stromal tumors, and hepatocellular carcinoma

Aurobindo Pharma gets 9 observations from USFDA for Unit 2 of Eugia Pharma Specialities

The observations are procedural in nature and will be responded to within the stipulated time

Touchlight unveils next-gen circular DNA portfolio for advanced gene therapies

The expanded mbDNA portfolio delivers enhanced stability, reduced immunogenicity, and broad compatibility with gene insertion and expression technologies

Zydus wellness reports 31% growth in net sales in Q2 FY26

During the quarter, Zydus Wellness completed the acquisition of Comfort Click Limited and its subsidiaries

AskBio’s gene therapy shows promising 12-month results for heart failure

Results demonstrate favorable safety profile and clinically meaningful improvements in patients with non-ischemic heart failure

Nanyang Biologics, NVIDIA, HPE & Equinix to launch AI drug discovery platform

Designed as an “AI-as-a-Service” platform, VECURA aims to reduce the traditional therapeutic drug discovery timeline of 10–12 years to just a few hours.

FDA completes inspection at Biocon Biologics' facility in Bengaluru

The U.S. FDA issued a Form 483 with five observations

Apitoria Pharma receives 5 observations from USFDA for API facility

At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported