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Human Drugs

Issues at San Francisco Research Institute

FDA warns Dr. Mark Savant and his San Francisco Research Institute about bioresearch monitoring violations in his conduct of a clinical investigation.

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Human Drugs

Biocons Interchangeable Insulin Approved

FDA approves a Biocon Biologics BLA for its rapid-acting interchangeable biosimilar insulin product Kirsty (insulin aspart-xjhz).

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Human Drugs

8 Observations in Sun Pharmaceutical FDA-483

FDA releases the form FDA-483 containing eight observations from an inspection at the Sun Pharmaceutical drug manufacturing facility in Halol, Gujarat...

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Human Drugs

FDA Urged to Incentivize Oncology Trials

Researchers, including CBER director Vinay Prasad, call for incentivized or mandated head-to-head randomized controlled trials of follow-on oncology d...

Medical Devices

BD Recalls Alaris Pump Due to Infusion Sets

BD and subsidiary CareFusion issue an Urgent Medical Device Recall (Correction) letter related to performance issues involving the BD Alaris Pump Modu...

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Biologics

CBER Director Overrides Staff to Limit Vaccine

CBER director Vinay Prasad again overrides career staff to limit a Covid vaccines use, according to a just-posted decisional memo.

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Human Drugs

Ultragenyx Gets Complete Response on Gene Therapy

FDA issues Ultragenyx Pharmaceutical a complete response letter on its BLA for UX111 (ABO-102), an investigational gene therapy for Sanfilippo syndrom...

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Human Drugs

Atara Refiles BLA for Gene Therapy

Atara Biotherapeutics resubmits its BLA for Ebvallo (tabelecleucel or tab-cel), seeking approval for its use as monotherapy for treating Epstein-Barr ...

FDA General

FDA Mum on Hiring Freeze and Staff RIFs

FDA faces new uncertainty over its staffing and regulatory capacity following sweeping federal hiring restrictions and a pivotal Supreme Court decisio...

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Human Drugs

Bayer sNDA for Kerendia Expanded Use Approved

FDA approves a Bayer supplemental NDA to expand the labeling of Kerendia (finerenone) for reducing the risk of cardiovascular death, hospitalization f...