New Delhi, The Centre is set to amend the New Drugs and Clinical Trials Rules, 2019, that would halve the statutory time to process applications for test licenses to manufacture or use a new drug in ...

The amendments aim to simplify the requirements and procedures for obtaining test licences and for submitting applications related to Bioavailability and Bioequivalence (BA/BE) studies ...

The health ministry has proposed new rules to cut drug trial approval time from 90 to 45 days, aiming to boost pharmaceutical ...

The agency's two main review offices will work together to flexibly evaluate medicines for serious conditions that affect ...

The FDA has accepted Stealth BioTherapeutics’ third new drug application for its ultrarare disease candidate, providing a planned decision date of Sept. 26. The timeline is surprising since the agency ...

Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase ...

With a flurry of recent Big Pharma investment in radiopharmaceutical therapeutics, the FDA issued draft guidance last month ...

The Indian government is amending drug regulations to expedite the approval process for clinical trials and ...

Using reprogrammed biocatalysts, researchers are pushing the boundaries of enzymatic synthesis with a method that opens the ...

NDA remains on track for FDA PDUFA goal date of January 31, 2026Commercial planning continues enabling rapid launch following approvalWARREN, ...

The Food and Drug Administration today announced a plan to publicly release complete response letters at the same time they ...

The U.S. Food and Drug Administration plans to fast-track reviews of four tobacco firms' nicotine pouches in a pilot program ...