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In a wide-ranging Inside Medicine Substack interview, FDA commissioner Martin Makary says there will be no broad reorganization at the agency, although some support functions will be combined to promote efficiency.

latest-news

Two Hogan Lovells attorneys discuss lessons medical device companies can learn about AI use from a recent FDA Warning Letter to Exer Labs.

LATEST NEWS

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No Broad FDA Reorganization Coming: Makary

In a wide-ranging Inside Medicine Substack interview, FDA commissioner Martin Makary says there will be no broad reorganization at the agency, although some support functions will be combined to promote efficiency.

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Learn from Exer Labs Warning on AI Use: Attorneys

Two Hogan Lovells attorneys discuss lessons medical device companies can learn about AI use from a recent FDA Warning Letter to Exer Labs.

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Bill Seeks to Kill Tax Deductions for DTC Ad Expenses

A group of bipartisan House lawmakers introduce the No Handouts for Drug Advertisements Act, a bill that would prohibit tax deductions for the annual $6 billion in expenses related to direct-to-consumer drug advertising.

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Cosco International CGMP Inspection Findings

FDA warns Marietta, GA-based Cosco International about CGMP violations in its production of unapproved and misbranded drugs.

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Animal Drugs

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medical-devices
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Inspections Will Suffer Under FDA Cuts: Lawyers

Recent FDA layoffs raise concerns across the drug and biologic industries as experts warn that diminished inspection capacity could slow drug approval...

medical-devices
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Self-Inject Vyvgart Hytrulo Approved

FDA approves an Argenx BLA for a new option for patients to self-inject Vyvgart Hytrulo prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) f...

medical-devices
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Rhythm Pharma ‘Positive’ Data on Obesity Drug

Rhythm Pharmaceuticals announces “positive topline results” from the pivotal Phase 3 TRANSCEND trial evaluating setmelanotide for treating acquired hy...

medical-devices
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Amgen’s Uplizna OK’d for Immunoglobulin G4 Disease

FDA approves an Amgen supplemental BLA for Uplizna (inebilizumab-cdon) for treating adults living with immunoglobulin G4-related disease.

Biologics

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medical-devices
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Abeona Gains Approval of Resubmitted Zevaskyn

FDA approves Abeona Therapeutics’ Zevaskyn (prademagene zamikeracel) gene-modified cellular sheets, an autologous cell-based gene therapy for treating...

medical-devices
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Trial Shows Value of Immunotherapy in Some Cancers

A Memorial Sloan Kettering Cancer Center Phase 2 trial demonstrates the value of immunotherapy in MMRd genetic mutation cancers instead of surgery, ra...

medical-devices
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Novavax, HHS Clarify on Post-approval Covid Study

Novavax and HHS clarify that FDA is requesting a post-approval study and not a clinical trial that must be conducted prior to approval of the company’...

medical-devices
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One-Third of Biosimilars Approved Not Launched: Report

A new biosimilars report says that FDA has approved a total of 73 biosimilars across 19 unique biological molecules, and so far only 48 (66%) of these...

FDA General

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medical-devices
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BlackfinBio Plans Gene Therapy Trial

FDA clears BlackfinBio to conduct a Phase 1/2 clinical trial of its novel adeno-associated virus gene therapy, BFB-101, in children with hereditary sp...

medical-devices
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RFK Jr. Restoring FDA’s Freedom of Information Office

HHS secretary Robert F. Kennedy Jr. vows to restore FDA’s and other health agencies’ Freedom of Information Act (FOIA) offices that were gutted earlie...

medical-devices
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ESG NextGen is Live: FDA

FDA says its Electronic Submission Gateway Next Generation is live and ready to receive submissions.

medical-devices
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Lt. Governors Urge Trump to Support FDA, Other Agencies

The Democratic Lieutenant Governors Association writes president Donald Trump urging him to support and safeguard the integrity of key federal science...

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Federal Register

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CDER Continues Quality Management Program

Federal Register notice: FDA seeks drug manufacturing establishments to participate in the second ye...

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Panel on Opioid Overdose Studies

Federal Register notice: FDA reschedules a previously planned drug safety advisory committee involvi...

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House Committee Hearing on Reducing FDA Inefficiencies

The U.S. House Committee on Oversight and Government Reform announces a 4/9 hearing on reducing inef...

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FDA Revokes EUAs on 3 Beckman Coulter Tests

Federal Register notice: FDA revokes Emergency Use Authorizations issued to Beckman Coulter for thre...

Human Drugs

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Cosco International CGMP Inspection Findings

FDA warns Marietta, GA-based Cosco International about CGMP violations in its production of unapprov...

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FDA Misses Review Decision on Stealth Bio NDA

FDA misses a 4/29 user fee review action extension on a Stealth BioTherapeutics NDA for elamipretide...

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Amazon Selling Unapproved, Misbranded Drugs: FDA

FDA warns Amazon it is marketing unapproved and misbranded external analgesic drug products for use ...

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Senator Hawley Urges FDA Action on Mifepristone Study

Senator Josh Hawley (R-Mo.) urges FDA commissioner Marty Makary to review a new study allegedly reve...

Marketing

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Bill Seeks to Kill Tax Deductions for DTC Ad Expenses

A group of bipartisan House lawmakers introduce the No Handouts for Drug Advertisements Act, a bill ...

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Drug Promotion Leaders Leave Agency

FDA Office of Prescription Drug Promotion director Catherine Gray and deputy director Mark Askine re...

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Lytgobi Web Page False, Misleading: FDA

The CDER Office of Prescription Drug Promotion cautions Taiho Oncology about misleading efficacy pre...

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Plus Therapeutics Gets Orphan Statis for Radiotherapy

FDA grants Plus Therapeutics an orphan drug designation for Rhenium (186Re) Obisbemeda, a radiothera...

Medical Devices

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Learn from Exer Labs Warning on AI Use: Attorneys

Two Hogan Lovells attorneys discuss lessons medical device companies can learn about AI use from a r...

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Medtronic Files PMA for Hugo Urology Surgical Robot

Medtronic files a PMA for its Hugo robotic-assisted surgery system for a urologic indication.

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Breakthrough Status for Blood Pressure Therapy

FDA grants Orchestra BioMed a breakthrough device designation for its atrioventricular interval modu...

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Abbott Recalls HeartMate Power Units

Abbott recalls its HeartMate Mobile Power Unit to remove the component due to instances where the de...