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AbbVie Seeks OK for All-Oral Leukemia Regimen

[ Price : $8.95]

AbbVie files a supplemental NDA seeking approval for a new, fixed-duration, all-oral combination regimen of Venclexta (venetoclax)...

FDA Ends Arthritis Advisory Committee

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FDA says its Arthritis Advisory Committee is no longer worth the effort and expense needed to maintain it, and it has been termina...

Speed Access to Drugs and Cut Drug Use: Makary

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FDA commissioner Martin Makary says he wants to find ways to get drugs to consumers faster, but also find ways to reduce the need ...

CBER Chief Prasad Fired, FDA Gold Standard Out Too?

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Newly appointed CBER director Vinay Prasad abruptly leaves the agency after being attacked by Trump influencer Laura Loomer for ex...

Calidi Bio Gets Fast Track for Sarcoma Therapy

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FDA grants Calidi Biotherapeutics fast-track status for CLD-201, an allogeneic stem-cell-loaded oncolytic virus being developed to...

J&J Seeks Label Update on Tremfya

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Johnson & Johnson files a supplemental BLA seeking to update the prescribing information for Tremfya (guselkumab) to include new d...

FDA Ratchets Up Heat on 7-OH Products

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FDA recommends placing 7-hydroxymitragynine (7-OH) a highly concentrated, synthetic byproduct of the kratom plant under the Contr...

Shiva Contract Lab CGMP Violations

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FDA warns Indias Shiva Analyticals Private Limited about CGMP violations in its work as a contract testing laboratory.

Quality Management Benefits Exceed Costs: FDA Paper

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The CDER Office of Pharmaceutical Quality publishes a white paper making the economic case for quality management practices.

Antibacterial Therapies Q&A Guidance

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FDA issues a question-and-answer guidance on the development of certain antibacterial therapies.