FDA Webview
X
latest-news

FDA Webview experiences technical difficulties that could limit the amount of text displayed in our current stories.

latest-news

FDA appoints Capitol Hill staffer Grace Graham as deputy commissioner for policy, legislation, and international affairs.

LATEST NEWS

View All
motusgi
FDA Webview Experiencing Technical Difficulties

FDA Webview experiences technical difficulties that could limit the amount of text displayed in our current stories.

motusgi
Hill Staffer Graham Appointed to FDA Policy Office

FDA appoints Capitol Hill staffer Grace Graham as deputy commissioner for policy, legislation, and international affairs.

motusgi
FDA Wants Contractors to Replace Some Fired Staff

FDA is recruiting contractors to do the travel logistics work for inspections and investigations that was done by staff who have been fired, according to Federal News Network and CBS.

motusgi
2 Medical Device FAQs Issued

FDA issues two documents answering frequently asked questions about reporting medical device recalls, corrections, and adverse events.

newsletter-first

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Animal Drugs

View All
medical-devices
Read More
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
Read More
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
Read More
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
Read More
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

View All
medical-devices
Read More
Celltrion’s Humira Biosimilar Now Interchangeable: FDA

FDA grants interchangeable biosimilar status to Celltrion’s Yuflyma (adalimumab-aaty), a biosimilar copy of AbbVie’s Humira.

medical-devices
Read More
Marks Warns of Growing Anti-Vaccine Stance

Former CBER director Peter Marks tells Time that he was seeing “an increasing anti-vaccine tone” before he resigned from the agency over pressure from...

medical-devices
Read More
Fast Track for H5N1 Flu mRNA Vaccine

FDA grants Arcturus Therapeutics a fast-track designation for the self-amplifying mRNA vaccine candidate, ARCT-2304, for protecting against H5N1 influ...

medical-devices
Read More
Outlook Refiles BLA for Wet AMD Drug

FDA accepts for review an Outlook Therapeutics BLA resubmission for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizu...

FDA General

View All
medical-devices
Read More
FDA Webview Experiencing Technical Difficulties

FDA Webview experiences technical difficulties that could limit the amount of text displayed in our current stories.

medical-devices
Read More
FDA Wants Contractors to Replace Some Fired Staff

FDA is recruiting contractors to do the travel logistics work for inspections and investigations that was done by staff who have been fired, according...

medical-devices
Read More
TEST

TEST

medical-devices
Read More
RFK Jr. Misfires at FDA Headquarters Address

An address to FDA staff at the White Oak, MD campus by HHS secretary Robert F. Kennedy Jr. diverts to “Deep State” rhetoric and accusations about agen...

newsletter-second

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Federal Register

View All
motusgi
Read More
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...

motusgi
Read More
FDA Revokes EUAs on 3 Beckman Coulter Tests

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

motusgi
Read More
Device Consensus Standards Publication

Federal Register notice: FDA updates its publication on modifications to the list of recognized cons...

motusgi
Read More
FDA Withdraws Sage’s NDA for Zulresso

Federal Register notice: FDA withdraws the approval of a Sage Therapeutics NDA for Zulresso (brexano...

Human Drugs

View All
motusgi
Read More
Trump to FDA: Boost Generics, OTCs, Rx Imports

A presidential executive order tells FDA to suggest administrative and legislative ways to improve t...

motusgi
Read More
Petition Seeks GMP Amendment for Sampling Logbooks

A citizen petition urges FDA to amend the requirements under 21 CFR Part 211 (finished pharmaceutica...

motusgi
Read More
AI in Regulatory Science: Conference Report

A report on the 2024 Global Summit on Regulatory Science calls for a collaborative global effort to ...

motusgi
Read More
Naturista Store Markets Unapproved Drug: FDA

FDA warns Downey, CA-based Naturista Store that it is marketing an unapproved, misbranded drug as a ...

Marketing

View All
motusgi
Read More
Lytgobi Web Page False, Misleading: FDA

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

motusgi
Read More
Plus Therapeutics Gets Orphan Statis for Radiotherapy

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

motusgi
Read More
Capricor BLA for Duchenne-related Cardiomyopathy

FDA accepts for priority review a Capricor Therapeutics BLA for deramiocel, a cell therapy for treat...

motusgi
Read More
OPDP Hits Edenbridge Pharma Over Promos

CDER's Office of Prescription Drug Promotion sends an untitled letter to Edenbridge Pharmaceuticals ...

Medical Devices

View All
motusgi
Read More
2 Medical Device FAQs Issued

FDA issues two documents answering frequently asked questions about reporting medical device recalls...

motusgi
Read More
Digital Health Technologies an FDA Priority: Article

Three FDA staffers discuss the agency’s efforts to advance the use of digital health technologies in...

motusgi
Read More
FDA Authorizes Click’s Migraine Digital Therapeutic

FDA grants Click Therapeutics a de novo marketing authorization for its prescription digital therape...

motusgi
Read More
TytoCare Get Clearance for AI Lung Sound Device

FDA clears a TytoCare 510(k) for its Tyto Insights for Rhonchi Detection, an artificial intelligence...