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ODT Launches Leadership Modernization Action Plan

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FDA launches a digital technology Leadership Modernization Action Plan.

Generic Drug Controlled Correspondence Revised Guidance

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FDA publishes a draft guidance updating with GDUFA 3 commitments a 2020 guidance on generic drug development controlled correspond...

FDA Delays Toripalimab PDUFA Action Date

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FDA delays the PDUFA action date for Junshi Biosciences toripalimab because Covid travel restrictions involving China are preventi...

Roche Priority Review BLA for B-cell Lymphoma

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FDA accepts a Roche BLA for priority review for glofitamab, an investigational CD20xCD3 T-cell engaging bispecific antibody for tr...

Cavazzoni Tries to Repair Credibility with New Alzheimers OK

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CDER director Patrizia Cavazzonitries to restore credibility within her Center by announcing the accelerated approval for a Biogen...

Hospira Recalls Injectable Vancomycin Due to Particulates

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Hospira recalls one lot of injectable vancomycin HCl single-dose fliptop 1.5 g vials due to two visible glass particulates observe...

Lupin Recalls 4 Quinapril Lots

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FDA says Lupin recalled one lot of 20 mg Quinapril tablets and three lots of 40 mg tablets due to the potential presence of N-Nitr...

FDA Approves Zycosan for Horses with Osteoarthritis

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FDA approves the first injectable pentosan product for use in horses with osteoarthritis.

Reverse Calif. Consumer Protection Regime: WLF

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Washington Legal Foundation asks the Supreme Court to reverse a California appeals court decision that hit Ethicon with $300 milli...

Genentechs Lunsumio OKd for Some Lymphomas

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FDA gives accelerated approval to Genentechs Lunsumio to treat some forms of follicular lymphoma.