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Pfizer Dumps Lotiglipron on Liver Injury Concerns

[ Price : $8.95]

Citing potential liver injury concerns, Pfizer says it is terminating the development program for glucagon-like peptide-1 receptor...

7-Year Echo: Marks Overrode Reviewers on Duchenne Therapy

[ Price : $8.95]

CBER director Peter Marks overrides the review team in the 6/22 accelerated approval of Sarepta Therapeutics Duchenne muscular dys...

Draft Guide on Medical Psychedelic Drugs

[ Price : $8.95]

FDA posts a draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations.

Senate FDA Appropriations Bill Includes $20 Million Increase

[ Price : $8.95]

The Senate Appropriations Committee approves FDAs appropriations bill, which provides the agency a $20 million spending increase.

Intercept Hit With 2nd Denial on NASH Drug

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FDA sends Intercept Pharmaceuticals a second complete response letter on its NDA resubmission for obeticholic acid for treating pr...

Guide on Cold-stored Platelets for Bleeding

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FDA posts a final guidance entitled Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment...

Guide on OTC Monograph Dispute Resolution

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Federal Register notice: FDA releases a draft guidance entitled Formal Dispute Resolution and Administrative Hearings of Final Adm...

Jazz Pharma Sues FDA Over Competitor Approval

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Jazz Pharmaceuticals sues FDA and seeks the reversal of a 5/1 approval of Avadel CNS Pharmaceuticals Lumryz, a sodium oxybate drug...

New Pathway for Breakthrough Device Coverage

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Centers for Medicare & Medicaid Services (CMS) issues a proposed procedural notice outlining a new Medicare coverage pathway for b...

Support In-Home Opioid Disposal: AGs

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Thirteen state attorneys general call on FDA to develop a plan for disposal of opioid drugs that includes at-home, single-use disp...