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

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

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

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

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AbbVie and Neomorph are set to enter a partnership and option-to-license agreement to develop molecular glue degraders.

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

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

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.

Biogen’s applications for the higher dose regimen of spinal muscular atrophy (SMA) drug Spinraza are now under review in the US and Europe.

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

Emergent Biosolutions (Gaithersburg, US) has purchased US and Canadian rights to Kloxxado, adding to its opioid overdose ...