Maharashtra FDA cancels Cipla C&F drug sale licences in Pune
The action follows inspections in June 2026 involving Reactin Plus Tablets, a Schedule H prescription medicine.
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Browsing Tag
FDA
SPARC receives Priority Review Voucher associated with Sezaby approval
Sun Pharma Advanced Research Company (SPARC) announced that the United States Food and Drug Administration (FDA) has granted a…
Granules Pharmaceuticals receives FDA tentative approval for gDYANAVEL XR
Granules Pharmaceuticals, a wholly owned subsidiary of Granules India, has received tentative approval (TA) from the US Food and…
Industry experts respond to FDA move to streamline biosimilar development
The agency through a separate initiative also plans to make it easier for biosimilars to be developed as interchangeable with…
FDA’s curb on overseas cell processing to hit smaller cell and gene therapy companies:…
Regulators haven’t specified how many trials are affected, though therapies like CAR-T, which sometimes use overseas manufacturing…
FDA discontinue rare pediatric disease designation program despite increase in RPD approvals
Due to concerns over its effectiveness, the US Congress did not renew the RPDD program and began to close it in late 2024
Entvin AI raises $500K in Y combinator funding to streamline FDA drug approval process
Entvin AI, founded by IIT Bombay graduates, launches its AI platform to optimise regulatory compliance for pharmaceutical…
FDA proposes removal of oral Phenylephrine from OTC nasal decongestant products
Agency cites lack of effectiveness as basis for proposed change, allowing continued sales pending final order
Continuous manufacturing: Changing the paradigm in the pharmaceutical manufacturing sector
The author explains how continuous manufacturing is reshaping pharmaceutical production
FDA issues warning letters to two Chinese firms over data integrity concerns
Agency flags nonclinical testing data and animal care violations, review ongoing