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CBER Director Prasad on Striking the Right Data Balance

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New CBER director Vinay Prasad defends his past criticisms of vaccines and says he is not anti-vax and promises that the Center wi...

Parkinsons Therapy Gets Regenerative Medicine Status

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FDA grants MeiraGTx Holdings a regenerative medicine advanced therapy designation for gene therapy AAV-GAD and its use for treatin...

FDA Preparing for Drug User Fee Negotiations

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FDA prepares to begin negotiation sessions in September to reauthorize the Prescription Drug User Fee Act, which expires 9/2027.

Makary Says Novavax BLA Decision is Forthcoming

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FDA commissioner Marty Makary says discussions are continuing with Novavax on its BLA to convert a 2022 emergency use authorizatio...

Paradigm Plans NDA for Rare Skin Disorder

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Paradigm Therapeutics plans an NDA submission in the second half of this year for Zorblisa (SD-101), as a topical whole-body treat...

Teal Health At-Home Pap Smear Approved

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FDA approves a Teal Health PMA for the Teal Wand, the first at-home vaginal sample, self-collection device for cervical cancer scr...

FDA Misses GSK Nucala for COPD Review Decision

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FDA again misses a user fee review action decision in the wake of mass staff cuts, the third miss in a month this time it's a GSK...

Odds Low for DTC Ad Ban: Conference Speakers

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Speakers at the DTC National conference suggest a ban on drug DTC ads is not very likely.

Gottlieb, McClellan Hit FDA Reorganization Plan

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Former FDA commissioners Scott Gottlieb and Mark McClellan voice concerns about an HHS proposed reorganization of FDA that would c...

FDA Ombudsman Recommends Stakeholder Education

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The FDA Office of Inspections and Investigations ombudsman program calls for establishing a dedicated Web page as a stakeholder ed...