FDA approves an Azurity Pharmaceuticals NDA for Konvomep (omeprazole and sodium bicarbonate for oral suspension), a proton pump inhibitor for treating...
FDA grants Vibrant Gastro de novo marketing authorization for its Vibrant, an orally administered drug-free capsule that provides mechanical stimulati...
FDA approves an AstraZeneca supplemental BLA for Imfinzi (durvalumab) for combination use with gemcitabine and cisplatin for adult patients with local...
Federal Register notice: FDA announces an 11/8 Pulmonary-Allergy Drugs Advisory Committee meeting to review AstraZeneca NDA for a combination metered ...
FDA issues a form FDA-483 with multiple inspection observations to Indias Biocon Biologics following three inspections at manufacturing sites in India...
Cue Health files a de novo marketing submission for its Cue Flu Molecular Test for at-home and point-of-care use.
The FDA FY 2021 GDUFA Science and Research Outcomes Report demonstrates how GDUFA research projects have contributed to the development of generic dru...
FDA says it is partnering with the Critical Path Institute to explore creating a Lysosomal Diseases Consortium as part of the Accelerating Rare Diseas...
