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Human Drugs

NeoMedical Screw System for Late-stage Tumors

FDA clears a Neo Medical 510(k) for the use of its Pedicle Screw System in late stage tumor indications in combination with Osartis BonOs Inject cemen...

Human Drugs

Tyvaso DPI Pulmonary Hypertension NDA Accepted

FDA accepts for priority review a United Therapeutics NDA for Tyvaso DPI (inhaled treprostinil) for treating pulmonary arterial hypertension.

Federal Register

Notice Correction on ANDA Approval Withdrawal

Federal Register notice: FDA corrects a 5/12 notice about the withdrawal of approval of 12 ANDAs from multiple applicants.

Human Drugs

FDA Extends Review Date for Ascendis Lonapegsomatropin

FDA extends the PDUFA action date for Ascendis lonapegsomatropin to 9/25.

Human Drugs

5 More Charged in Drug Diversion Scheme

The Justice Department says a Florida grand jury indicted five more individuals in a massive drug diversion scheme.

Human Drugs

Web Site Selling Illegal New Drugs, FDA Says

FDA warns the Web site at www.pharmacygeoff.md that it is selling misbranded unapproved new drugs in the U.S.

Human Drugs

Cerevel Fast Track on Dementia-Related Apathy Drug

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

Human Drugs

FDA Real-World Evidence in Cancer Treatment Study

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

Medical Devices

Attorney Sees Positive Step in Pauls VITAL Act

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

Federal Register

Comments Sought on Study Data Exchange Standards

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