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Biogen Accelerated Approval for ALS Drug

[ Price : $8.95]

FDA grants Biogen accelerated approval for Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis associated with...

FDA Lifts Hold on Maat Pharma Phase 3 Trial

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FDA lifts its clinical hold against a MaaT Pharma IND for an open-label, single arm Phase 3 pivotal clinical trial evaluating the ...

Senate Bipartisan Agreement on FDA Reform Bills

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Senate HELP Committee leaders reach a legislative bipartisan deal to expand the availability of low-cost generic drugs, clarify or...

Info Collection on Customer Service Surveys

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Federal Register notice: FDA seeks comments on an information collection extension entitled Customer/Partner Service Satisfaction ...

FDA Sends Non-Compliance Letter to Sun Pharma

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FDA sends a letter to Sun Pharma telling the company that it is out of compliance with a 2012 consent decree after an inspection l...

CGMP Violations at Egypts Pharmaplast

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FDA warns Alexandria, Egypt-based Pharmaplast about CGMP violations in its manufacturing of finished drugs.

Florida Files 2nd Drug Import Suit Against FDA

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In two suits, Florida says FDA is violating the Freedom of Information Act by not responding to the states request for information...

Supreme Court Gives FDA Temporary Victory

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The U.S. Supreme Court grants FDA a temporary win by ordering a stay of a lower courts order to restrict the distribution of the a...

OPDP Plans Survey on DTC Quantitative Claims

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CDERs Office of Prescription Drug Promotion discusses a survey to better understand quantitative claims in direct-to-consumer pres...

Applied Therapeutics Seeks Pre-NDA Meeting for Govorestat

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Applied Therapeutics says it will request a pre-NDA meeting with FDA on govorestat (AT-007) and its use in treating patients with ...