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FDA Reminds on Recalled Exactech Joint Devices

[ Price : $8.95]

FDA reminds patients and healthcare providers about risks associated with recalled Exactech replacement joint devices that were pa...

Dupixent Meets Key Phase 3 Endpoints: Regeneron

[ Price : $8.95]

Regeneron and Sanofi say an investigational Phase 3 trial of Dupixent in some COPD patients met all key primary and secondary endp...

Workforce, Education for Regenerative Medicine

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The Government Accountability Office reports on regenerative medicine and advanced therapies workforce and education/training need...

OSTP Goals for Biotechnology and Biomanufacturing

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A new White House Office of Science and Technology Policy (OSTP) report lists 10 bold goals for the U.S. biotechnology and biomanu...

Device Cybersecurity is Top Concern for Shuren

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CDRH director Jeff Shuren tells an Alliance for Stronger FDA Webinar that cybersecurity is one of the biggest concerns that keeps ...

Cidar/Melintas Rezzayo Wins FDA Approval

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FDA approves a Cidara Therapeutics and Melinta Therapeutics NDA for Rezzayo (rezafungin for injection) for treating candidemia and...

Consider Antitrust in Apokyn Generic Case: FTC

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The Federal Trade Commission asks the Delaware federal court to consider four antitrust implications in deciding whether to grant ...

Complete Response for AbbVie Parkinsons NDA

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FDA issues AbbVie a complete response letter for ABBV-951 (foscarbidopa/foslevodopa) for treating motor fluctuations in adults wit...

Registry Set Up for Breast Implant Carcinoma Reports

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FDA says events involving squamous cell carcinoma in the scar tissue (capsule) that forms around breast implants should be reporte...

Shionogis Mulpleta Regulatory Review Period

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Shionogi & Co.s Mulpleta (l...