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A new report from the Association for Accessible Medicines calls for changes to FDA policies, patent law, pharmacy benefit manager practices and federal reimbursement policies that it says are threatening the long-term sustainability of the generic and biosimilar markets.

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FDA grants Pharming Group expanded approval for Joenja (leniolisib) tablets for treating activated phosphoinositide 3-kinase delta syndrome in children 4-11 years old.

LATEST NEWS

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Group Calls for Policy Changes to Sustain Generic, Biosimilar Competition

A new report from the Association for Accessible Medicines calls for changes to FDA policies, patent law, pharmacy benefit manager practices and federal reimbursement policies that it says are threatening the long-term sustainability of the generic and biosimilar markets.

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Pharming Group’s Joenja Gets Expanded Approval

FDA grants Pharming Group expanded approval for Joenja (leniolisib) tablets for treating activated phosphoinositide 3-kinase delta syndrome in children 4-11 years old.

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Exelixis NDA Review Extended for Colorectal Cancer Drug

FDA extends by three months its review of an Exelixis NDA for zanzalintinib, in combination with atezolizumab, for treating patients with metastatic colorectal cancer.

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FDA Oncology Chief to Focus on AI, Streamlined Drug Development

Oncology Center of Excellence director Angelo de Claro says the center will build on initiatives established under longtime and former OCE chief Richard Pazdur while using artificial intelligence and other approaches to streamline cancer drug development.

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Animal Drugs

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Antimicrobial Animal Drug Finalized Safety Guidance

FDA issues a finalized guidance on evaluating the safety of antimicrobial animal drugs based on their role in human medicine.

medical-devices
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Petition Urges FDA to Restrict Antibiotic Use in Animals

A coalition of 65 health, environmental, consumer, farming, and animal welfare organizations petition FDA to withdraw approvals for the routine use of...

medical-devices
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FDA Authorizes 1st Generic Animal Drug for New World Screwworm

FDA authorizes Felix Pharmaceuticals’ generic nitenpyram tablets to treat New World screwworm infestations in dogs and cats.

medical-devices
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Open Letter to Trump Urges FDA Push on Rare Diseases

In an opern letter to president Trump, rare disease advocates urge him to push FDA to accelerate approvals for treatments targeting fatal genetic diso...

Biologics

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medical-devices
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Nanoscope BLA Accepted for Vision Restoration Gene Therapy

FDA accepts for review a Nanoscope Therapeutics BLA seeking approval for Mogenry, an optogenetic gene therapy designed for vision restoration in patie...

medical-devices
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Bioresearch Monitoring Violations Found

FDA warns Stephen Fallon of Wilton Manors, FL, about bioresearch violations in his role as clinical investigator of a trial of an investigational prod...

medical-devices
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Repeat Fenwal International CGMP Issues Cited

FDA cautions Fenwal International about CGMP deviations at its Maricao, Puerto Rico, facility that manufactures blood pack units.

medical-devices
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uniQure Files BLA for Huntington’s Gene Therapy

Following a course reversal by FDA, uniQure files a BLA seeking accelerated approval of ifezuntirgene inilparvovec (AMT-130), an investigational gene ...

FDA General

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medical-devices
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FDA-SEC Info Sharing Raises Disclosure, Insider Trading Concerns

A Sheppard analysis warns that regulated industry should expect closer scrutiny of statements about FDA interactions and broaden their insider-trading...

medical-devices
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Hogan Lovells Hires Former FDA Chief Counsel Raza

Former FDA chief counsel Mark Raza joins Hogan Lovells Cadwalader as senior counsel in its Pharmaceuticals and Biotechnology practice.

medical-devices
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Letter Campaign Seeks to Block FDA Commissioner Nominee

There appears to be growing opposition to FDA commissioner nominee Heidi Overton, as a letter-writing campaign is underway to block her Senate confirm...

medical-devices
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Food & Drug Legal Icon Peter Barton Hutt Passes Away at 91

Former FDA chief counsel Peter Barton Hutt passes away at the age of 91.

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Federal Register

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FDA Moves to Cement Complete Response Letter Transparency Policy

FDA looks to formalize one of its most significant transparency initiatives in decades: the public r...

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FDA Warns Brazilian Drug Maker Over Records Request

FDA sends a Warning Letter to Brazilian over-the-counter drug manufacturer Aeroflex Industria de Aer...

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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...

Human Drugs

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Group Calls for Policy Changes to Sustain Generic, Biosimilar Competition

A new report from the Association for Accessible Medicines calls for changes to FDA policies, patent...

motusgi
Read More
Pharming Group’s Joenja Gets Expanded Approval

FDA grants Pharming Group expanded approval for Joenja (leniolisib) tablets for treating activated p...

motusgi
Read More
Exelixis NDA Review Extended for Colorectal Cancer Drug

FDA extends by three months its review of an Exelixis NDA for zanzalintinib, in combination with ate...

motusgi
Read More
FDA Oncology Chief to Focus on AI, Streamlined Drug Development

Oncology Center of Excellence director Angelo de Claro says the center will build on initiatives est...

Marketing

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FDA Hits Alar Pharmaceuticals Experimental Ketamine Promotion

FDA issues Alar Pharmaceuticals an untitled letter over promotional materials for its investigationa...

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FDA Promotion Crackdown Enters New Phase: Attorneys

Attorneys from Arnall Golden Gregory examine and offer advice on FDA’s intensified scrutiny of drug ...

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FDA Plan Would ‘Fundamentally Reshape’ Drug Ads

Two Sheppard attorneys say an FDA proposal to require complete safety and risk information within th...

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FDA Cites Sanofi Over Misleading Beyfortus Promotional Emails

FDA sends an untitled letter to Sanofi Vaccines U.S., alleging that promotional emails for its respi...

Medical Devices

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BMC Medical Recalls Sleep Apnea Machines

BMC Medical recalls its Luna G3 APAP (Model LG3600), an auto-adjusting positive airway pressure mach...

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GenAI Devices to See Increased Scrutiny: Law Firm

A Crowell & Moring analysis says FDA may increase regulatory scrutiny for user-facing GenAI-enabled ...

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Heartvue’s MRI-Reviewing Software Cleared

FDA grants Heartvue.ai a 510(k) clearance for its Heartvue.Proton, a machine learning–powered softwa...

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Boston Scientific Recalls Spinal Cord Stimulator Leads

Boston Scientific recalls all unused spinal cord stimulator Infinion CX Leads after determining that...