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Parkinsons Therapy Gets Regenerative Medicine Status

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

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...

Orchestra BioMeds Trial OKd on Sirolimus Balloon

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FDA approves an Orchestra BioMed IDE to begin a pivotal clinical trial evaluating its next generation Virtue Sirolimus-AngioInfusi...

Fast Track Awarded to Polycythemia Vera Drug

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FDA grants Italfarmaco a fast track designation to givinostat for treating patients with polycythemia vera, a rare hematologic can...

FDA Implementing AI-Assisted Scientific Review

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FDA commissioner Michael Makary says the agency is rolling out a generative AI-assisted scientific review tool to all Centers by 6...

Court Confirms FDA Drug Shortage Ruling was Valid

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A northern Texas judge rules in FDAs favor in a case challenging its decision last year to remove Eli Lillys weight loss and diabe...