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Vivace Mesothelioma Drug Gets Orphan Status

[ Price : $8.95]

FDA grants Vivace Therapeutics an orphan drug designation for VT3989 and its use in treating mesothelioma.

House Dems Hit FDA, HHS Over Vaccines

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Top House Democrats on the Energy and Commerce Committee raise alarm over what they describe as a coordinated effort by the Trump ...

FDA Lays Out Unapproved GLP-1 Drug Concerns

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FDA issues an online statement summarizing all its concerns with unapproved versions of GLP-1 weight loss drugs being marketed to ...

AbbVie Seeks OK for All-Oral Leukemia Regimen

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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...

Multiple Violations at Onkos Surgical

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FDA warns Parsippany, NJ-based Onkos Surgical about Quality System and Medical Device Reporting violations in its work as a medica...

CGMP Deviations in Macsen Drugs Inspection

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FDA warns Indias Macsen Drugs about CGMP deviations in its production of active pharmaceutical ingredients.