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FDA Alert on Abiomed Impella Controllers

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

FDA Rejects sNDA for Rexultis Use in PTSD

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FDA rejects Otsuka Pharmaceutical and H. Lundbecks sNDA to expand the use of Rexulti (brexpiprazole) for treating post-traumatic s...

FDA Takes Actions to Curb Autism

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FDA takes two actions against autism by ordering a label change against acetaminophen (Tylenol) use in pregnancy approving leucovo...

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FDA posts a draft guidance entitled Malaria: Developing Drugs for Treatment that outlines key considerations for companies develop...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