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FDA Tumult Keeps Makary Under Microscope: NYT Article

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The New York Times reports that ongoing turmoil at FDA has increasingly placed commissioner Marty Makary under the microscope, rai...

FDA Cites GSK Hungary Vaccine Plant

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FDA cites a GlaxoSmithKline biologicals manufacturing site in Hungary for significant lapses in deviation investigations and mater...

Catalent Issued 2 FDA Form 483s

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FDA posts two separate Form 483 inspection reports citing a range of quality and compliance deficiencies at Catalent Maryland, Inc...

AstraZeneca Pulling Andexxa From Market Due to Safety

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A new FDA safety update says safety risks associated with AstraZenecas Andexxa outweigh the drugs benefits, leading the agency to ...

FDA Flags Sterility/Quality Control at SCA Pharma

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FDA cites SCA Pharmaceuticals for multiple deficiencies in sterile drug manufacturing practices following a 10-day inspection of t...

Cobenfy TV Spot False or Misleading: FDA

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The CDER Office of Prescription Drug Promotion says a TV spot for Karuna Therapeutics Cobenfy is false or misleading in its descri...

UBI FDA-483 Has 5 Observations

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FDA releases the form FDA-483 with five observations from a recent inspection of the UBI Pharma drug manufacturing facility in Hsi...

Lillys Oral GLP-1 Maintains Weight Loss After Switch

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A new study shows that Eli Lillys investigational oral obesity drug helped patients largely maintain weight loss after transitioni...

Novo Nordisk Files CagriSema NDA for Weight Loss

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Novo Nordisk says it expects FDA to review in 2026 the companys NDA for CagriSema, an injectable once-weekly weight loss treatment...

FDA Sends Warning Letters to Makers of Breast Binders

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FDA begins enforcement actions against companies illegally marketing breast binders to children, placing the agencys role at the c...