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FDA General

FDA Cancels Union Session on Layoffs

FDA cancels a scheduled meeting with the National Treasury Employees Union, which represents thousands of FDA staff, to discuss the impact of layoffs ...

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Human Drugs

RM Pharma Gains Low-Dose HemiClor Approval

FDA approves an RM Pharma 505(b)(2) for HemiClor (12.5 mg chlorthalidone) tablets for treating hypertension in adults.

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Biologics

Clinical Trials for Covid Boosters: Makary

FDA commissioner Martin Makary reiterates that he wants to see clinical trials for new Covid vaccine boosters.

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Medical Devices

Teleflex Gains Expanded Use on QuikClot Device

FDA clears a Teleflex 510(k) for an expanded indication for its QuikClot Control+ Hemostatic Device to include all grades of internal and external ble...

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Human Drugs

Amicis Research Didnt Follow Investigation Plan: FDA

FDA warns Dr. Nana Barseghian about a bioresearch monitoring violation in a clinical trial at Northridge, CA-based Amicis Research Center.

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Human Drugs

Trump Administration Seeks Mifepristone Case Dismissal

The Trump administration asks a federal judge to dismiss a lawsuit filed by three GOP states that seeks to block access to the abortion pill mifeprist...

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Human Drugs

Experts Dismiss FDA Drug Development Tools Program

Genentech researchers say FDAs Drug Development Tools Qualification program has had a very limited impact on development programs.

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Human Drugs

Lab Test Ruling Could Apply to AI at FDA: Researchers

Public health researchers warn about the broader impacts to emerging technologies (e.g., artificial intelligence) in a March court ruling that struck ...

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Biologics

ImmunityBio sBLA Filing Refused on Expanded Indication

FDA sends ImmunityBio a refusal to file letter for its recent supplemental BLA submission seeking approval for Anktiva plus Bacillus Calmette-Guerin f...

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Human Drugs

Capricor Therapeutics Passes Mid-Cycle Review

Capricor Therapeutics says it has completed an FDA mid-cycle review meeting on a BLA seeking approval for deramiocel and its use in treating Duchenne ...