For Immediate Release: August 01, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

Reference #: FEI 3002785310 Product: Drugs Recipient: Recipient Name Mr. Scott A. Smith Recipient Title Chief Executive Officer Mylan Laboratories Limited Unit 8, a Viatris Company […]

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Ms. Heather Bresch Recipient Title Chief Executive Officer Mylan Laboratories Limited – Unit 8 1000 Mylan BoulevardCanonsburg, […]

Summary Company Announcement Date: July 29, 2023 FDA Publish Date: July 31, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Out of Specification Results […]

Who is affected by high blood pressure? Approximately 1 in 3, more than 100 million, American adults have high blood pressure. But only half of those […]

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Mr. Nimish Chudgar Recipient Title Chief Executive Officer & Managing Director Intas Pharmaceuticals Limited Plot No. 255, […]

Multiple Endpoints Guidance Snapshot Regulations, Laws, Guidances; Clinical Trials, Drug Development and Approval Ethical Considerations for Clinical Investigations Involving Children -Guidance Snapshot Regulations, Laws, Guidances; Clinical […]

On July 31, 2023, the Food and Drug Administration approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent […]

On This Page Date: November 27, 2018 Time: 1:30 PM – 2:30 PM ET Organized By: [embedded content] Tuesday, November 27, 20181:30pm – 2:30pm (Eastern)  The […]