Purdue Pharma and its owners, the Sackler family, have reached a $7.4bn settlement with US states to resolve a long-running ...

The FDA has granted approval for the ANDA of Lupin’s Sacubitril and Valsartan Tablets for heart failure patients.

The FDA rejected the company’s initial NDA in 2021, citing the lack of an adequate trial to demonstrate efficacy.

Emcure Pharmaceuticals has opened its new formulation research and development (R&D) centre at Ahmedabad, in the Indian state ...

Adaptive logistics are vital for clinical trials, but there are challenges in navigating complexities of regulations and ...

A new report dives into the evolving clinical trial landscape and transformative therapies changing lives for bladder cancer ...

The Pharmaceutical Technology Excellence Awards winners have been announced! Download our full 50+ page report to find out ...

Critical pain points need to be overcome for the animal healthcare industry to achieve its full potential.

Disc Medicine finalised the pivotal Phase III trial design of bitopertin in erythropoietic protoporphyria (EPP) with the FDA ...

The FDA reported that six patients died after being injected with Teva’s Copaxone or Sandoz’s Glatopa. The US Food and Drug ...

The year ahead in clinical trials looks set to be one that is challenged and influenced by regulatory developments, new guidance, and broader political shifts.

The FDA has granted orphan drug designation (ODD) to Zai Lab’s ZL-1310, aimed at treating small cell lung cancer (SCLC).