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FDA accepts a Telix Pharmaceuticals resubmitted NDA for TLX101-Px, an investigational PET imaging agent for glioma.

latest-news

FDA issues Replimune another complete response letter, declining to approve its BLA for vusolimogene oderparepvec in combination with nivolumab for advanced melanoma.

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Telix NDA Resubmission for Brain Cancer Imaging Agent

FDA accepts a Telix Pharmaceuticals resubmitted NDA for TLX101-Px, an investigational PET imaging agent for glioma.

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FDA rejects Replimune Melanoma Therapy Again

FDA issues Replimune another complete response letter, declining to approve its BLA for vusolimogene oderparepvec in combination with nivolumab for advanced melanoma.

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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 congressional push for more pre-review of direct-to-consumer ads.

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RFK Jr. Tones Down Vaccine Skepticism in Run Up to Midterms

HHS secretary Robert F. Kennedy Jr. curtails his public commentary on vaccines as part of a deliberate political strategy by the Trump administration for its midterm election campaign.

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Animal Drugs

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medical-devices
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Enforcement, Advertising Oversight Shape Regulatory Landscape: Legal Update

A legal update from ArentFox highlight several emerging regulatory and enforcement developments at FDA thatare expected to have significant implicatio...

medical-devices
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Partial Hold on Myotonic Dystrophy Type 1 Therapy

FDA places a partial clinical hold on a mid-stage U.S. trial of PepGen Inc.’s experimental therapy for myotonic dystrophy Type 1.

medical-devices
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FDA Warns Elanco Animal Health About Pradalex Ads

The Center for Veterinary Medicine warns Elanco Animal Health about false and misleading claims in promotional materials for its Pradalex that treats ...

medical-devices
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Antimicrobial Drug Duration of Use Guidance

FDA publishes a guidance with recommendations for how sponsors of animal drugs may facilitate changes to the approved conditions of use of specific ty...

Biologics

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medical-devices
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FDA rejects Replimune Melanoma Therapy Again

FDA issues Replimune another complete response letter, declining to approve its BLA for vusolimogene oderparepvec in combination with nivolumab for ad...

medical-devices
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Organogenesis Advances ReNu Toward FDA Filing After Key Meeting

Organogenesis says it has reached agreement with FDA that clears the way for a rolling BLA submission for its knee osteoarthritis product ReNu.

medical-devices
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Positive Phase 3 Date for Subcutaneous Tepezza: Amgen

Amgen reports positive topline results from a Phase 3 trial evaluating a subcutaneous version of its thyroid eye disease drug Tepezza (teprotumumab-tr...

medical-devices
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FDA Flags Quality System Gaps at CSL Behring Site

FDA posts a Form 483 that identifies deficiencies in quality system procedures at a manufacturing facility operated by CSL Behring GmbH in Marburg, Ge...

FDA General

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medical-devices
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RFK Jr. Tones Down Vaccine Skepticism in Run Up to Midterms

HHS secretary Robert F. Kennedy Jr. curtails his public commentary on vaccines as part of a deliberate political strategy by the Trump administration ...

medical-devices
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Inspection Cites Thermo Fisher Manufacturing Facility

FDA cites GMP deficiencies at a facility operated by Thermo Fisher Scientific (Patheon Italia unit) in Ferentino, Italy.

medical-devices
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FDA Budget Proposal Signals Push for Tighter Ad Oversight

Law firm Sheppard breaks down some of FDA’s proposals in its budget documents that industry should keep a close eye on, including new DTC ad authoriti...

medical-devices
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Doctor Failed to Follow Investigational Plan: FDA

FDA warns Newport Beach, CA-based physician Ehsan Sadri about failing to follow the investigational plan in two clinical trials.

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Federal Register

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Mitapivat Moving Toward Accelerated Approval in Sickle Cell: Agios

Agios Pharmaceuticals says it plans to seek accelerated approval for mitapivat in sickle cell diseas...

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PDUFA Public Meeting for User Fee Reauthorization

Federal Register notice: FDA announces a 7/14 public meeting to discuss proposed recommendations for...

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Generic Drug Fee Program Reauthorization Meeting

Federal Register notice: FDA hosts a 7/11 public meeting on the reauthorization of the Generic Drug ...

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FDA Withdraws and Reissues 2 Guidances

FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissui...

Human Drugs

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Telix NDA Resubmission for Brain Cancer Imaging Agent

FDA accepts a Telix Pharmaceuticals resubmitted NDA for TLX101-Px, an investigational PET imaging ag...

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America First Fee Incentives Discussed in PDUFA Meeting

Minutes of the 3/10 and 3/12 PDUFA 8 reauthorization steering committee sessions, progress was repor...

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Granules Steps Up Oversight at Troubled India Facility

Granules India Ltd tightens oversight of its manufacturing operations at its largest facility ba...

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Vanda Blasts FDA Plan to Lengthen Drug Review Times

Vanda Pharmaceuticals says FDA should withdraw a legislative proposal in its budget package that the...

Marketing

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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...

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Alymsys Patient Brochure False or Misleading: FDA

The CDER Office of Prescription Drug Promotion says an Amneal patient brochure for its Avastin biosi...

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Lucemyra Web Site Home Page False or Misleading: FDA

FDA cautions BioCorRx about false and misleading information on the Web site home page for its Lucem...

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Modernize DTC Ads with QR Code: WLF

A Washington Legal Foundation background document suggests that Congress change direct-to-consumer d...

Medical Devices

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FDA, Device Industry Reach Agreement on MDUFA VI

FDA and the device industry are nearing a final agreement on the next round of Medical Device User F...

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Medline Class 1 Recall of Angiographic Control Syringes

Medline Industries recalls (Class 1) its angiographic control syringes, warning the devices could ca...

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Medline Industries QS Violations Cited

FDA warns Glens Falls, NY-based Medline Industries about Quality System violations in its manufactur...

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FDA Opens READI-Home Innovation Challenge

FDA solicits applications for its new READI-Home innovation challenge to use medical technology in t...