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 ...
AbbVie and Neomorph are set to enter a partnership and option-to-license agreement to develop molecular glue degraders.
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The Pharmaceutical Technology Excellence Awards winners have been announced! Download our full 50+ page report to find out ...
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.