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Human Drugs

Acadia Pharmaceuticals NDA for Rett Syndrome

Acadia Pharmaceuticals files an NDA for trofinetide for treating Rett syndrome in adults and pediatric patients two years of age and older.

Human Drugs

Lawmakers Push FDA for ALS Therapies

A group of bipartisan lawmakers write FDA asking that it do more to help get therapies approved for treating amyotrophic lateral sclerosis (Lou Gehrig...

Human Drugs

FDA Reform Needed to Address Lack of Urgency: Forbes

Pacific Research Institute president Sally Pipes says FDAs foot dragging in recommending updated Covid-19 vaccines last month and in approving the rel...

FDA General

Senator Burr Introduces 'Clean' Version of User Fee Bill

Senator Richard Burr (R-NC) introduces a "watered-down" and less controversial FDA user fee reauthorization bill that is intended to address Republica...

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Human Drugs

Pfizers Xalkori OKd for Myofibroblastic Tumors

FDA approves a Pfizer supplemental NDA for Xalkori (crizotinib) for adult and pediatric patients with unresectable, recurrent, or refractory inflammat...

Human Drugs

Court Takes Action Against Edge Pharm

A federal court has permanently enjoined a Colchester, VT, compounding pharmacy from distributing drugs unless they are manufactured in compliance wit...

Medical Devices

Eko Murmur Smart Stethoscope Software Cleared

FDA clears an Eko 510(k) for its Eko Murmur Analysis Software for use in its smart stethoscope for detecting and characterizing murmurs.

Medical Devices

Use Swab Samples of Lesions to Detect Monkeypox: FDA

An FDA safety communication advises that testing for monkeypox virus should use swab samples taken directly from a lesion to avoid false test results.

Federal Register

FDA Revoking Methods of Analysis Regulation

Federal Register proposed rule: FDA proposes to revoke its methods of analysis regulation (21 CFR 2.19) that describes policy to use certain methods o...

Federal Register

FDA Revokes EUA on Covid Detection Kit

Federal Register notice: FDA revokes the emergency use authorization issued to ScienCell Research Laboratories for its ScienCell SARSCoV2 Coronavirus ...