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Human Drugs

ALX Oncology Seeking Accelerated OK for Evorpacept

ALX Oncology plans to discuss with FDA its path for seeking accelerated approval for CD47-blocker evorpacept based on “positive updated data” from the ASPEN-06 Phase 2 clinical trial in patients with previously treated HER2-positive advanced gastric or gastroesophageal junction cancer.

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Human Drugs

FDA Approves Medexus Leukemia NDA

FDA approves a Medexus NDA for Grafapex (treosulfan) for use with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in patients with acute myeloid leukemia or myelodysplastic syndrome.

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Human Drugs

Keytruda+Lenvima Mixed Data in Gastroesophageal Cancer

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Human Drugs

Caranx Medical PMA for TAVIpilot AI Software

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Human Drugs

Fast Track for Prostate Cancer Imaging Drug

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Human Drugs

CDRH’s Sara Brenner Elevated to Acting Commissioner

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ALX Oncology Seeking Accelerated OK for Evorpacept

ALX Oncology plans to discuss with FDA its path for seeking accelerated approval for CD47-blocker evorpacept based on “positive updated data” from the ASPEN-06 Phase 2 clinical trial in patients with previously treated HER2-positive advanced gastric or gastroesophageal junction cancer.

motusgi
FDA Approves Medexus Leukemia NDA

FDA approves a Medexus NDA for Grafapex (treosulfan) for use with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in patients with acute myeloid leukemia or myelodysplastic syndrome.

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FDA Delays Non-Rx Drug Final Rule

Responding to a Trump Administration order, FDA delays the effective date until 3/21 of a recent final rule entitled “Nonprescription Drug Product With an Additional Condition for Nonprescription Use (ACNU).”

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CDRH’s Sara Brenner Elevated to Acting Commissioner

HHS elevates CDRH chief medical officer for in vitro diagnostics Sara Brenner to FDA acting commissioner under the Trump Administration.

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Animal Drugs

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Canine Librela Adverse Events Analyzed: CVM

FDA says it has completed its evaluation of several adverse effects found in dogs treated with Librela for pain associated with osteoarthritis.

medical-devices
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Animal Drug Regs Amended to Reflect Approvals

Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug-related applications.

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Elanco Gets Anti-Itch Zenrelia Approved for Dogs

FDA approves Elanco Animal Health’s Zenrelia (ilunocitinib tablets), a once-daily oral JAK inhibitor for controlling itching associated with allergic ...

medical-devices
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CVM Draft Guide on CMC Technical Section

FDA releases a CVM draft guidance entitled “Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies.”

Biologics

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medical-devices
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CBER Approved 67 Products in 2024: Report

CBER director Peter Marks’ report for 2024 discusses Center approval of 67 products it says integrated advances in science and technology.

medical-devices
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Replimune BLA for Melanoma Gets Priority Review

FDA accepts for priority review a Replimune Group BLA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced mel...

medical-devices
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Califf Final Essay Touts Covid Vaccines

As he prepares to resign his post, FDA commissioner Robert Califf posts what is likely his final essay and personal reflection on the safety and effec...

medical-devices
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6 Human Cell, Tissue Donor Eligibility Guides

FDA publishes one draft general and five specific immediately effective guidances to help establishments understand regulations governing donor eligib...

FDA General

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medical-devices
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Former FDA Women’s Health Head Wood Dies

Former FDA associate commissioner for women’s health Susan Wood passes away at her home in London after battling glioblastoma (brain cancer).

medical-devices
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FDA Union Sues Trump Over Schedule F

The union representing FDA employees sues President Trump over efforts to replace many Civil Service workers with political appointees.

medical-devices
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Temporary Embargo on FDA Communications

The Trump Administration places a temporary embargo on external communications by FDA and other government health agencies until political appointees ...

medical-devices
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Commissioners’ Suggestions for Martin Makary

FDA commissioner Robert Califf and three former commissioners offer their perspectives on the ways the incoming administration can succeed at FDA.

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Federal Register

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Animal Drug Regs Amended for Recent Approvals

Federal Register notice: FDA amends its regulations to reflect recent application-related actions fo...

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FDA Seeks Comments on Cannabis Use in Animals

Federal Register notice: FDA seeks public comments on the use of cannabis-derived products (CDPs) in...

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Guide on Reducing Malaria Transmission

Federal Register notice: FDA makes available a draft guidance entitled “Recommendations To Reduce th...

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23 No-Longer-Marketed Generics Withdrawn

Federal Register notice: FDA withdraws approval of 23 ANDAs from multiple applicants after they told...

Human Drugs

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ALX Oncology Seeking Accelerated OK for Evorpacept

ALX Oncology plans to discuss with FDA its path for seeking accelerated approval for CD47-blocker ev...

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FDA Approves Medexus Leukemia NDA

FDA approves a Medexus NDA for Grafapex (treosulfan) for use with fludarabine as a preparative regi...

motusgi
Read More
FDA Delays Non-Rx Drug Final Rule

Responding to a Trump Administration order, FDA delays the effective date until 3/21 of a recent fin...

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CDRH’s Sara Brenner Elevated to Acting Commissioner

HHS elevates CDRH chief medical officer for in vitro diagnostics Sara Brenner to FDA acting commissi...

Marketing

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Durbin, Grassley Reintroduce Drug Ad Price Bill

A bipartisan group of senators reintroduce legislation to mandate the inclusion of drug prices in di...

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DTC Ad Enforcement to Increase Under Trump: Panel

Lawyers on a Food & Drug Law Institute enforcement panel warn that the incoming Trump administration...

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New DTC Major Statement Standards Become Effective

New FDA advertising standards require drug marketers to ensure their direct-to-consumer advertisemen...

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‘False or Misleading’ Xeomin Promotion: FDA

FDA cautions Merz over misleading representations about its Xeomin in a promotional piece featuring ...

Medical Devices

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Implement Digital Technologies Carefully: GE HealthCare

Two medical device stakeholders suggest ways for FDA to regulate generative AI and foundation model-...

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Inflammatix Sepsis Molecular Diagnostic Cleared

FDA clears an Inflammatix 510(k) for its TriVerity Test System, which it describes as a first-in-cla...

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CDRH Authorized 120 Novel Devices in 2024

CDRH’s annual report says it granted marketing authorization to 120 novel devices in 2024, which was...

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Medline Fluid Delivery Sets Recalled

Medline Industries recalls its Medline Fluid Delivery Set with Drip Chamber because the devices were...