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Human Drugs

Monjuvi Approved for Follicular Lymphoma

FDA approves Incytes Monjuvi (tafasitamab-cxix) in combination with lenalidomide and rituximab for treating adults with relapsed or refractory follicu...

Medical Devices

FDA Clears DeepEcho AI Fetal Ultrasound

FDA clears a DeepEcho 510(k) for its artificial intelligence-based fetal ultrasound analysis platform.

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Human Drugs

Cycles Harliku Approved for Alkaptonuria

FDA approves a Cycle Pharmaceuticals NDA for Harliku (nitisinone) tablets for reducing urine homogentisic acid in adult patients with alkaptonuria.

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Human Drugs

FDA Warns on Transderm Scop Heat Complications

FDA warns that Baxter Healthcares antinausea patch Transderm Scop (scopolamine transdermal system) can increase body temperature and cause heat-relate...

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Marketing

DTC Ads Kennedys Next Target?

Bloomberg News says President Trump and HHS secretary Kennedy are looking at policies that they hope would drive drug companies away from DTC advertis...

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Human Drugs

FDA Approves Gileads Yeztugo for HIV Prevention

FDA approves Gileads Yeztugo as the only HIV pre-exposure prophylaxis twice-yearly option.

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Human Drugs

GDUFA Post-Warning Letter Meeting Guidance

FDA publishes a guidance on its implementation of the post-Warning Letter meeting established in the GDUFA 3 commitment letter to allow eligible facil...

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Open Bipartisan Probe of RFK Vaccine Plans: Pallone

House Energy and Commerce Committee ranking Democrat Frank Pallone calls for a bipartisan committee investigation of HHS secretary Robert Kennedys act...

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Biologics

CBERs Prasad Named Chief Medical/Scientific Officer

CBER director Vinay Prasad has been appointed as FDAs chief medical and scientific officer, a new combination role for commissioner Marty Makary.

Human Drugs

Bavarian Nordic Sells Priority Voucher for $160 Million

Bavarian Nordic enters into an agreement to sell for $160 million a priority review voucher that was awarded for gaining approval of its chikungunya v...