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HHS Assists FDA with BDs Bactec Shortage

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HHS says it is working with FDA to help resolve an ongoing supply shortage of BDs Bactec blood culture media bottles.

Imfinzi OKd for Resectable Lung Cancer

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AstraZeneca gains FDA approval for Imfinzi (durvalumab) with platinum-containing chemotherapy for adults with resectable non-small...

Court Nixes Restraining Order Request in Entresto Suit

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The Washington DC District Court rejects a Novartis motion in a generic drug carve-out case for a preliminary injunction to stay F...

No-Longer-Marketed Enteregs Approval Withdrawn

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Federal Register notice: FDA withdraws approval of Cubist Pharmaceuticals Entereg (alvimopan) capsules because it is no longer mar...

Regulatory Review Period for B+Ls Miebo

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Bausch + Lombs eye drug Mie...

FDA Debars Ryan Stabile for 15 Years

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Federal Register notice: FDA debars Ryan Stabile for 15 years from importing or offering for import any drug into the U.S.

More FDA Stringency Seen on Accelerated Drug OKs

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Two Sheppard Mullin attorneys say sponsors of drugs approved through expedited pathways should learn from a recent FDA untitled le...

FDA Clears Cresilons Traumagel

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FDA clears Cresilons Traumagel device that uses a plant-based technology to control moderate to severe bleeding at the point of ca...

FDA Touts CDER Advanced Manufacturing Research Facility

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FDA describes CDERs new state-of-the-art advanced manufacturing research facility.

Priority Review for Imfinzi sBLA in Lung Cancer

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FDA accepts for priority review an AstraZeneca supplemental BLA for Imfinzi (durvalumab) and its use in certain patients with limi...