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Human Drugs

Endo Wants Generic Epinephrine Restrictions

Endo asks FDA not to receive or approve any applications for a generic form of Endos epinephrine products that do not refer to the Endo NDA.

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FDA General

Vaccine Skeptic Kennedy Confirmed as HHS Secretary

The U.S. Senate votes 52-48 to confirm vaccine skeptic Robert F. Kennedy Jr. to serve as the next HHS secretary.

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Human Drugs

Study Sees New Trazodone Adverse Events

Researchers in China say they found several new adverse event signals in their review of 20 years of FDA adverse event reports on the antidepressant t...

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Human Drugs

FDA Still Faster than EMA on Cancer Approvals

A Friends of Cancer Research study update says FDA continues to review and approve novel cancer drugs faster than the European Medicines Agency.

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Biologics

Sanofi/J&J Scrap E. Coli Vaccine Candidate

Sanofi and Johnson & Johnson stop the development of their vaccine candidate for extraintestinal pathogenic E. coli because Phase 3 data show that it ...

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Human Drugs

Court Rules for FDA in Vanda Label Case

The DC District Court rules for FDA in a Vanda Pharmaceuticals lawsuit seeking an agency order to revoke the approval of a Teva ANDA for a generic cop...

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Medical Devices

DoJ Probing Inspire Marketing, Reimbursement

The Department of Justice has requested information from Inspire Medical as part of a civil probe into its marketing, promotion, and reimbursement pra...

Human Drugs

FDA Clarifies Compounded GLP-1 Enforcement

FDA clarifies its enforcement discretion timeframes for compounded tirzepatide.

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Human Drugs

Genentech Gets New Evrysdi Tablet Approval

FDA approves a Genentech NDA for a new tablet formulation of Evrysdi (risdiplam) for treating people with spinal muscular atrophy.

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Human Drugs

Travere Therapeutics Plans Filspari sNDA

Travere Therapeutics says it will submit an sNDA to FDA for a new indication for its Filspari to treat focal segmental glomerulosclerosis.