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FDA Amends Animal Drug Regs for Approvals

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Federal Register notice: FDA amends the animal drug regulations to reflect application-related actions for applications made durin...

FDA Withdrawing 5 No-Longer-Marketed ANDAs

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Federal Register notice: FDA withdraws approval of five ANDAs from multiple applicants after they notified the agency that the dru...

Pfizer sBLA for Interchangeable Humira Biosimilar

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FDA accepts for review a Pfizer supplemental BLA for Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Abbotts Humira...

Smart Surgical Gets Warning Letter on BioBurst Products

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FDA sends Boise, ID-based Smart Surgical, dba Burst Biologics, a Warning Letter after an inspection last year determined it is mar...

Teleflex Expanded Indication for Catheters/Guidewires

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FDA clears a Teleflex expanded indication for its specialty catheters and coronary guidewires for use in crossing chronic total oc...

FDA OKs Sage ANDA for Generic Apokyn Cartridges

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FDA approves a Sage Chemical ANDA for the first generic version of Mylans Apokyn (apomorphine hydrochloride injection) drug cartri...

Legislators Continuing to Push for VALID Act

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Speakers at a Friends of Cancer Research program on diagnostic tests push the VALID Act and the need for an FDA framework for regu...

FDA Extends Imcivree sNDA After Major Amendment

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FDA extends by three months its review of a Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide) for treating obes...

Info Collection Tobacco Substantial Equivalence Exemptions

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Federal Register notice: FDA seeks comments on an information collection extension entitled Exemptions From Substantial Equivalenc...

FDA Tightens Sotrovimab EUA

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FDA says GSK/Virs sotrovimab should not be used in geographic areas where Covid infection is likely to have been caused by a non-s...