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FDA Approval Reciprocity Bill Reintroduced

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Rep. Chip Roy (R-TX) reintroduces the Reciprocity Ensures Streamlined Use of Lifesaving Treatments" (RESULT) Act that would expedi...

FDA Approves New Treatment for Pneumonia

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FDA approves an Entasis Therapeutics NDA for Xacduro (sulbactam and durlobactam for injection), a new treatment for hospital-acqui...

FDA Agrees to PolyPid Phase 3 Study Design

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FDA agrees to a PolyPid Phase 3 trial (SHIELD II) design revision evaluating D-PLEX 100 (doxycycline) for preventing abdominal col...

Petition for Warning on Diabetes Drugs Denied

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FDA denies a Public Citizen petition that sought a Boxed Warning for all sodium-glucose cotransporter-2 inhibitor drugs contraindi...

CDRH Portal Expanded to Pre-Submission Feedback

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FDA updates its CDRH Portal to allow users to track the progress of pre-submissions for obtaining feedback on potential marketing ...

Blueprint Medicines Mastocytosis NDA Approved

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FDA approves a Blueprint Medicines NDA for Ayvakit (avapritinib) for treating adults with indolent systemic mastocytosis.

Novo Nordisk Plans NDA for Oral Obesity Drug

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Novo Nordisk plans to file an NDA for obesity drug semaglutide 50 mg tablets after announcing that the Phase 3a OASIS 1 trial met ...

Rain Oncology Scraps Milademetan

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Rain Oncology says it will cease further development of milademetan in dedifferentiated liposarcoma after reporting disappointing ...

FDA Withdraws NDA on Abbotts Cyclert

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Federal Register notice: FDA withdraws approval of Abbotts NDA for Cyclert (pemoline) tablets, indicated for treating attention-de...

FDA OKs Opiant Pharmas Opioid Overdose Spray

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FDA approves an Opiant Pharmaceuticals NDA for Opvee (nalmefene HCl) nasal spray for the emergency treatment of a known or suspect...