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Cerevel Fast Track on Dementia-Related Apathy Drug

[ Price : $8.95]

FDA grants Cerevel Therapeutics a fast track designation for CVL-871, a selective dopamine D1/D5 partial agonist in development fo...

FDA Real-World Evidence in Cancer Treatment Study

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FDA opens a five-year collaboration with ConcertAI to evaluate real-world outcomes and safety in cancer treatments.

Attorney Sees Positive Step in Pauls VITAL Act

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Attorney Jeffrey Shapiro says legislation sponsored by Sen. Rand Paul to have CMS take the lead in the regulation of laboratory-de...

Comments Sought on Study Data Exchange Standards

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Federal Register notice: FDA seeks comments on the use of study data exchange standards from stakeholders involved in study conduc...

510(k) Exemption Petition: Powered Patient Transport

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Federal Register notice: FDA announces that it received a petition requesting exemption from the premarket notification requiremen...

FDA Claims Transparency, Value for Complex Generic Drugs

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OGD Office of Research and Standards director Robert Lionberger describes steps FDA has taken to foster the development of complex...

Sanofi Aubagio Data Not Sufficient for New Indication: FDA

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FDA says Sanofi did not submit sufficient data to justify approving an Aubagio sNDA for an indication for pediatric patients with ...

StrataGraft Approved for Thermal Burns

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FDA approves Stratatechs StrataGraft, a cellularized scaffold for treating adult patients with certain thermal burns.

Panel Meeting to Review TransMedics PMA

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Federal Register notice: FDA announces a 7/14 meeting of it Medical Devices Advisory Committees Gastroenterology and Urology Devic...

Notice Corrected on Bravecto Review Period

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Federal Register notice correction: FDA corrects a 2/12/2018 Federal Register notice to revise the regulatory review period for Me...