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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...

PDUFA Talks Hit Snag on Review Timelines/Transparency

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During recent drug user fee negotiations on reauthorizing the PDUFA program, FDA officials and pharmaceutical industry representat...

FDA OKs Subcutaneous Version of J&J Lung Cancer Drug

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FDA approves a new subcutaneous formulation of Johnson & Johnsons lung cancer drug amivantamab, allowing the therapy to be adminis...

Clinical Hold on Lung Cancer Trial After Deaths

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Regulators place a clinical hold on a pivotal lung cancer trial of ifinatamab deruxtecan after reports of treatment-related deaths...

Republicans Dismiss RFK Jr. Subpoena Vote for Testimony

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House Energy and Commerce Committee Republicans blocked an effort by Democrats to compel HHS secretary Robert F. Kennedy Jr. to te...

Sen. Johnson Seeks FDA Docs on Covid Vaccine Deaths

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Sen. Ron Johnson (R-WI) demands that FDA turn over records related to an internal review that linked Covid-19 vaccinations to the ...