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Senators Want Overseas Drug Inspection Info

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Sens. Rick Scott and Kirsten Gillibrand ask FDA commissioner Martin Makary to answer 11 questions about the agencys oversight of o...

Olympus Recalls ViziShot 2 FLEX Needles

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Olympus recalls (Class 1) its ViziShot 2 FLEX (19G) EBUS-TBNA needles manufactured before 5/12 after receiving reports of device c...

FDA Alert on Abiomed Impella Controllers

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FDA issues an early alert after becoming aware that Abiomed had issued a letter to affected customers recommending certain Automat...

FDA Rejects Biogen's High-Dose Spinraza

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FDA issues Biogen a complete response letter on a supplemental NDA for a high-dose regimen of Spinraza (nusinersen) for treating s...

Guide on Enforcement Discretion for Emergency-Use IVDs

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FDA posts a final guidance outlining how the agency will decide when to temporarily allow use of unapproved diagnostic tests durin...

Stealth Wins Approval for Barth Syndrome Drug

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FDA grants accelerated approval to a Stealth Biotherapeutics NDA for Forzinity (elamipretide) injection for treating Barth syndrom...

FDA Extends Review on Sanofi Multiple Sclerosis NDA

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FDA extends by three months its review of Sanofis multiple sclerosis drug tolebrutinib to evaluate additional analyses submitted r...

Roches Giredestrant Shows Promise in Breast Cancer

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Roche reports positive Phase 3 data with its investigational breast cancer drug giredestrant.

FDA Issues Guidance on Malaria Drug Development

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FDA posts a draft guidance entitled Malaria: Developing Drugs for Treatment that outlines key considerations for companies develop...

Lexicon Submits New Data to FDA on Zynquista

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Lexicon Pharmaceuticals says FDA is requiring additional time to review its new clinical data submitted earlier this month in an e...