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House Energy and Commerce Committee republicans ask HHS inspector general Christi Grimm to assess the adequacy of FDA’s oversight and support of its Office of Laboratory Safety.

latest-news

A coalition of 18 attorneys general file a Fourth Circuit appellate brief in support of a lower court decision finding that North Carolina “cannot impose unnecessary and burdensome restrictions” to access the abortion drug mifepristone that were rejected by FDA.

LATEST NEWS

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House GOPers Seek IG Probe on FDA Lab Safety

House Energy and Commerce Committee republicans ask HHS inspector general Christi Grimm to assess the adequacy of FDA’s oversight and support of its Office of Laboratory Safety.

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18 State Attorneys General Support Mifepristone Ruling

A coalition of 18 attorneys general file a Fourth Circuit appellate brief in support of a lower court decision finding that North Carolina “cannot impose unnecessary and burdensome restrictions” to access the abortion drug mifepristone that were rejected by FDA.

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Lenz Therapeutics NDA Accepted for Farsightedness

FDA accepts for review a Lenz Therapeutics NDA for LNZ100 (aceclidine), an eyedrop medication for treating presbyopia.

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FDA Clears Design Changes to Zio AT

FDA clears an iRhythm Technologies 510(k) related to prior design changes made to the Zio AT cardiac telemetry device.

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Animal Drugs

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FDA releases a CVM draft guidance entitled “Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies.”

medical-devices
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FDA Publishes 2 Revised VICH Guidances

FDA publishes two revised Veterinary International Conference on Harmonization guidances on validation of analytical procedures for veterinary drugs.

medical-devices
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VICH Residual Solvents Guidance

FDA publishes a Veterinary International Conference on Harmonization revised guidance on residual solvents used in animal drugs.

Biologics

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medical-devices
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FDA OKs Vyloy for Rare Gastric Cancer

FDA approves an Astellas Pharma BLA for Vyloy (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the f...

medical-devices
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FDA Holds Novavax Covid/Flu Vaccine IND

FDA places a clinical hold on the Novavax IND for a Covid-19/influenza combination vaccine and influenza standalone vaccine following a report of one ...

medical-devices
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GSK Plans BLA for Nasal Polyp Therapy

GSK says it will submit a BLA based on positive data from two Phase 3 trials evaluating depemokimab in chronic rhinosinusitis with nasal polyps.

medical-devices
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GSK Says Arexvy Protects Over Three RSV Seasons

GSK says trial data show its Arexvy protects through three complete RSV seasons.

FDA General

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medical-devices
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House GOPers Seek IG Probe on FDA Lab Safety

House Energy and Commerce Committee republicans ask HHS inspector general Christi Grimm to assess the adequacy of FDA’s oversight and support of its O...

medical-devices
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FDA Inspections Reorganization Effective 10/1

FDA begins implementing a new model for FDA inspections as part of an agency-wide reorganization that was brought on by the 2022 infant formula debacl...

medical-devices
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FDA Discusses Optimizing Advisory Committees

FDA commissioner Robert Califf and other top officials outline areas the agency believes can be optimized to help improve the advice received from adv...

medical-devices
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RFK Jr. to Recommend Trump Health Agency Heads?

Mainstream health gadfly Robert K. Kennedy, Jr., says he has been asked by Donald Trump to be heavily involved in choosing people to run FDA and other...

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Federal Register

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Pfizer’s Vyndagel Regulatory Review Period

Federal Register notice: FDA determines for patent term extension purposes the regulatory review per...

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Regulatory Review Period for Pfizer’s Vyndamax

Federal Register notice: FDA determines for patent extension purposes the regulatory review period f...

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Guide on Post-Op Nausea Drug Development

Federal Register notice: FDA makes available a draft guidance entitled “Postoperative Nausea and Vom...

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Guide on Oncology Patient-Reported Outcomes

Federal Register notice: FDA makes available a final guidance entitled “Core Patient-Reported Outcom...

Human Drugs

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18 State Attorneys General Support Mifepristone Ruling

A coalition of 18 attorneys general file a Fourth Circuit appellate brief in support of a lower cour...

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Lenz Therapeutics NDA Accepted for Farsightedness

FDA accepts for review a Lenz Therapeutics NDA for LNZ100 (aceclidine), an eyedrop medication for tr...

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Novo Nordisk to Seek Rybelsus Expanded Label

Novo Nordisk says it will submit a NDA supplement seeking an expanded label for its diabetes drug Ry...

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NDA for Liver Cancer Combo Therapy Resubmitted

FDA accepts for review an Elevar Therapeutics NDA resubmission for its investigational drug rivocera...

Marketing

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FDA to Study Drug Promotion in Talk Shows

The CDER Office of Prescription Drug Promotion says it will research how using an endorser to provid...

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FDA Pushed to Regulate Online Drug Promos

Gardner Law says prescription drug manufacturers and marketers need to be sure their social media pr...

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FDA to Survey Healthcare Providers

The CDER Office of Prescription Drug Promotion releases plans to survey 2,400 healthcare providers o...

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Enforce Regulation of ‘Wellness’ Devices: Petition

Spark Biomedical, a manufacturer of an FDA-approved neurostimulation device, asks the agency to ensu...

Medical Devices

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FDA Clears Design Changes to Zio AT

FDA clears an iRhythm Technologies 510(k) related to prior design changes made to the Zio AT cardiac...

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Boston Scientific Recalls Obsidio Embolic Device

Boston Scientific recalls (Class 1) its Obsidio Conformable Embolic device to update the use instruc...

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GE Recalls Neo-Natal Incubators

GE Healthcare recalls its Giraffe OmniBed neo-natal incubator after receiving reports about the scre...

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FDA Clears Medical AI Imaging Software

FDA clears a Bracco Diagnostics and Subtle Medical 510(k) for their artificial intelligence-powered ...