Accurate, sensitive mass techniques required to identify specific peak of certain nitrosamines
Continuing its investigation into the presence of potential carcinogenic materials in various medicines, on May 28, the US FDA…
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USFDA
Zydus Cadila receives tentative US FDA approval for Droxidopa Capsules
Droxidopa is used to treat symptoms of low blood pressure when standing, caused by a medical condition called neurogenic…
Gilead scouting for partners in India, Pak for remdesivir
Recent clinical trial results and the decision by the US Food and Drug Administration (FDA) to issue ''Emergency Use…
USFDA extends review of Bristol Myers’ cancer therapy acquired in Celgene deal
The company said it had submitted additional information on the therapy known as liso-cel, which was considered a major amendment…
FDA approves first targetted therapy to treat aggressive form of lung cancer
The FDA also approved the FoundationOne CDx assay (F1CDx) as a companion diagnostic for Tabrecta
The US Food and Drug…
FDA approves Dr Reddy’s NDA for migraine drug
The company is working to commercialise Elyxyb (previously known as DFN-15), which is indicated for the acute treatment of…
FDA approves Farxiga for heart failure
Farxiga was shown in a clinical trial to improve survival and reduce the need for hospitalisation in adults with heart failure…
Natco Pharma gets USFDA approval for Visakhapatnam facility
The company did not disclose the product approved by the USFDA to be produced from the facility
J B Chemicals gets USFDA approval for Carbamazepine ER Tablets
The product is a generic version of Tegretol XR tablet in the same strength of Novartis Pharma
Natco Pharma gets EIR from USFDA for Telangana facility
USFDA had conducted pre-approval inspection at Natco’s facility in Kothur village from March 2-6, 2020