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FDA Withdrawing 7 No-Longer-Marketed ANDAs

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Federal Register notice: FDA withdraws the approval of seven ANDAs from multiple applicants after they notified the agency that th...

North American Diagnostics Recalls Covid Tests

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North American Diagnostics recalls its Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits because they were distributed without FDA aut...

Beam Hit With Clinical Hold on CAR-T Therapy

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FDA issues a clinical hold on Beam Therapeutics BEAM-201 and its use in treating relapsed/refractory T-cell acute lymphoblastic le...

Minor Use, Minor Species Reporting Collection

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Federal Register notice: FDA seeks comments on an information collection entitled Reporting Associated With Designated New Animal ...

ImmunityBio Files BLA for Bladder Cancer Therapy

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FDA accepts for review an ImmunityBio BLA for its antibody cytokine fusion protein as a treatment for certain patients with Bacill...

Hold Lifted on Celyad Oncology CAR T Therapy

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FDA removes a clinical hold on Celyad Oncologys CYAD-101-002 (KEYNOTE-B79) Phase 1b trial after the company modified the eligibili...

FDA Approves Stelara in Pediatric Psoriatic Arthritis

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FDA approves Janssens Stelara (ustekinumab) for treating pediatric patients six years of age and older with active psoriatic arthr...

AstraZeneca Scraps Monalizumab Clinical Study

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AstraZeneca says discontinued a monalizumab study after a planned futility interim analysis of the INTERLINK-1 Phase 3 study did n...

Guide on Disposable Drug Manufacturing Materials

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FDA posts a final guidance entitled Changes to Disposable Manufacturing Materials: Questions and Answers.

Sidley Breaks Down Device Whistleblower Case Dismissal

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Law firm Sidley draws attention to a recent southern Florida federal court dismissal of a whistleblower lawsuit that declined to e...