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Conditional Approval for Marginal New Drugs: Avorn

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Harvard Medical School professor Jerry Avorn says FDA needs to take a nonbinary approach to some drug approvals with a conditional...

FDA OKs Amendment to Uproleselan Trial

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FDA clears a Phase 3 protocol amendment to allow a time-based analysis of Glycomimetics uproleselan if sufficient survival events ...

Public Citizen Urges FDA to Reject Duchenne BLA

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Public Citizens Health Research Group urges FDA to not grant accelerated approval to Sarepta Therapeutics gene therapy SRP-9001 fo...

American Labs Bowel Disease Assay Cleared

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FDA clears an American Laboratory Products 510(k) for its Calprotectin Immunoturbidimetric Assay as an aid in diagnosing inflammat...

FDA Partial Hold on Mersana Trials

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FDA issues a partial clinical hold against Mersana Therapeutics clinical trials of UpRi (upifitamab rilsodotin) in platinum-sensit...

Aldeyra Reports Reproxalap Conjunctivitis Data

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Aldeyra Therapeutics says the Phase 3 INVIGORATE-2 Clinical Trial of 0.25% reproxalap ophthalmic solution in patients with allergi...

FDA to Decide Florida Drug Import by 10/31

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A Florida federal judge stays the states Administrative Procedure Act claims against FDA over the states drug import plan until 11...

Pfizer Warns of Bicillin Shortages

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Pfizer says select presentations of its Bicillin L-A and Bicillin C-R prefilled syringes are expected to be depleted later this ye...

Surmodics Low Profile Thrombectomy System Cleared

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FDA clears a Surmodics 510(k) for its Pounce LP (Low Profile) Thrombectomy System.

Guide on Device Software Functions

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Federal Register notice: FDA makes available a final guidance entitled Content of Premarket Submissions for Device Software Functi...