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FDA places a clinical hold on an Aardvark Therapeutics clinical trial on its experimental metabolic drug ARD-101 based on a cardiac safety issue.

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The U.S. Supreme Court temporarily preserves nationwide access to the abortion pill mifepristone by mail, blocking a lower court ruling that would have reinstated in-person dispensing requirements.

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Clinical Hold on Aardvark Trial Over Safety Issue

FDA places a clinical hold on an Aardvark Therapeutics clinical trial on its experimental metabolic drug ARD-101 based on a cardiac safety issue.

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High Court Backs Abortion Pill Access for Now

The U.S. Supreme Court temporarily preserves nationwide access to the abortion pill mifepristone by mail, blocking a lower court ruling that would have reinstated in-person dispensing requirements.

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FDA Acting Drugs Head to Leave Agency Soon: Report

Reuters reports that CDER acting director Tracey Beth Hoeg is expected to leave the agency just days after the resignation of former FDA commissioner Marty Makary.

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Democratic Health Leaders Question FDA Study Suppression

Democratic leaders on the House Energy and Commerce Committee accuse HHS secretary Robert F. Kennedy Jr. of suppressing scientific research supporting the safety and effectiveness of Covid-19 vaccines.

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Animal Drugs

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medical-devices
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FDA Guide on Developing Drugs for Pulmonary Tuberculosis

FDA posts updated guidance outlining how drugmakers should design clinical development programs for new tuberculosis treatments, emphasizing the need ...

medical-devices
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White House Reportedly Moves to Oust Commissioner Makary

Several media outlets report that President Trump has signed off on a plan to remove FDA commissioner Marty Makary from his post.

medical-devices
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Atara says FDA outlined potential path for Cell Therapy Resubmission

Atara Biotherapeutics says it and partner Pierre Fabre Pharmaceuticals have received feedback from FDA outlining a potential path toward resubmitting ...

medical-devices
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Lilly to Seek FDA Approval for Foundayo in Diabetes

Eli Lilly says it will seek expanded FDA approval by the end of the quarter for its obesity drug Foundayo (orforglipron) as a treatment for diabetes, ...

Biologics

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medical-devices
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Democratic Health Leaders Question FDA Study Suppression

Democratic leaders on the House Energy and Commerce Committee accuse HHS secretary Robert F. Kennedy Jr. of suppressing scientific research supporting...

medical-devices
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Partner Therapeutics Wins Approval for Bile Duct Cancer Therapy

FDA approves a Partner Therapeutics BLA for Bizengri (zenocutuzumab-zbco) for adults with advanced, unresectable or metastatic cholangiocarcinoma harb...

medical-devices
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CBER Acting Head Highlights Regulatory Flexibility, AI and Rare Disease Priorities

CBER acting director Katherine Szarama discusses an expansive vision for the biologics center during remarks at the Food and Drug Law Institute’s annu...

medical-devices
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Scrutiny of Gene Therapy Evidence Intensifies After Recent Setbacks

An opinion article notes that recent FDA regulatory decisions are leading to a sharper focus on the evidentiary standards underpinning cell and gene t...

FDA General

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medical-devices
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FDA May be OK Under Loper Bright: Article

University of Missouri law professor Erika Lietzan says FDA may not suffer as much under the Supreme Court’s Loper Bright decision as policy analysts ...

medical-devices
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Despite Makary Leaving, Industry Could Feel Pressure: Analysis

Analysts and investors interviewed by Reuters see a short-term positive reaction to the departure of Marty Makary, but caution that a prolonged leader...

medical-devices
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Inspection Pilot May be Permanent as FDA Expands AI-Driven Oversight

A King & Spalding legal analysis examines FDA’s newly announced pilot program for one-day inspectional assessments, suggesting it may signal a long-te...

medical-devices
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FDA Commissioner Makary Resigns After Administration Pressure

FDA commissioner Marty Makary hands in his resignation after a week of mounting speculation that the Trump Administration was preparing to remove hi...

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Federal Register

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FDA Delays Review Action on Alzheimer’s Drug

FDA delays by three months its decision on Eisai and Biogen's subcutaneous starting-dose formulation...

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Alnylam Pharma’s Web Promo is Misleading: FDA

FDA sends an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a c...

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PhRMA Urges Changes to FDA’s ‘Plausible Mechanism’ Guidance

PhRMA urges FDA to broaden and clarify its draft guidance on individualized therapies, warning that ...

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Purdue Sentencing Sets $5.3 Billion in Criminal Penalties

A federal court sentences Purdue Pharma to pay more than $5 billion in criminal penalties for its ro...

Human Drugs

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Clinical Hold on Aardvark Trial Over Safety Issue

FDA places a clinical hold on an Aardvark Therapeutics clinical trial on its experimental metabolic ...

motusgi
Read More
High Court Backs Abortion Pill Access for Now

The U.S. Supreme Court temporarily preserves nationwide access to the abortion pill mifepristone by ...

motusgi
Read More
FDA Acting Drugs Head to Leave Agency Soon: Report

Reuters reports that CDER acting director Tracey Beth Hoeg is expected to leave the agency just days...

motusgi
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Critics Pile on Makary’s Ouster with Melanoma Drug Denial

FDA’s recent rejection of an experimental melanoma treatment becomes a flashpoint in broader critici...

Marketing

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Brukinsa TV Ad ‘False or Misleading’: OPDP

A CDER Office of Prescription Drug Promotion Notice of Violation cites a misleading BeOne Medicine T...

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Advertising Experts Critique FDA’s Increasing Enforcement

Pharmaceutical advertising experts react to FDA’s dramatically altered enforcement approach toward p...

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Nubeqa TV Ad, Video Misleading: FDA

The CDER Office of Prescription Drug Promotion cautions Bayer that a video and TV ad for its Nubeqa ...

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Will the Push for DTC Pre-Review Grow?

Two Hyman, Phelps & McNamara attorneys describe the impacts on industry if FDA responds to a congres...

Medical Devices

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Early Alert on Drager Anesthesia Workstations

FDA issues an early alert warning healthcare providers about a potentially high-risk problem involvi...

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Petition Urges Actions Against Weight Loss Device

A citizen petition urges FDA to take enforcement action against the BariClip, an implantable bariatr...

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Boston Scientific Device Correction on Certain Pacemakers

Boston Scientific begins a Class 1 recall (device correction) involving certain pacemakers and cardi...

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Guidance On Patient-Matched Guides for Orthopedic Implants

FDA posts a new guidance detailing how manufacturers should design and submit regulatory application...