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Guide to Increase Female Enrollment in Trials

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FDA publishes a draft guidance aimed at increasing the enrollment of females in clinical trials of drugs and medical devices.

Trump Taps Controversial Figure to Lead Cancer Panel

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President Trump appoints Yale epidemiologist Harvey Risch to chair the Presidents Cancer Panel, a move that is raising alarm among...

7 Observations on ProRx FDA-483

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FDA releases the form FDA-483 with seven observations from an inspection at the Exton, PA-based ProRx outsourcing facility.

Microvascular Tissue Marketing Unapproved New Drug

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FDA warns San Diego, CA-based Microvascular Tissue about CGMP violations in its production and marketing of an unapproved new drug...

FDA Commissioner Defends Vaccine Stance, Transparency Push

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In a recent interview, FDA commissioner Marty Makary positions himself as a supporter of vaccines while defending recent agency ac...

Makary Says No Plans for Covid Vaccine Boxed Warning

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FDA commissioner Marty Makary says the agency has no plans to add a Black Box Warning to Covid vaccines, contradicting a report fr...

Vanda Antibody BLA for Pustular Psoriasis

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Vanda Pharmaceuticals files a BLA for imsidolimab and its use in treating generalized pustular psoriasis, a rare and potentially f...

FDA Awards Priority Voucher for Multiple Myeloma Combo

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FDA proactively awards Johnson & Johnson a national priority voucher for teclistamab in combination with daratumumab for treating ...

Sanofi Scraps Tolebrutinib MS Filing after Phase 3 Miss

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Sanofi says it will not seek FDA approval for tolebrutinib in primary progressive multiple sclerosis after the drug failed to meet...

Restrictions on Real-World Evidence Regulatory Reviews Eased

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FDA says it is removing a long-standing barrier to the use of real-world evidence in regulatory reviews by accepting such data wit...