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Tvardi Therapeutics says its experimental drug TTI-101 failed to show benefit in a Phase 2 clinical trial for idiopathic pulmonary fibrosis.

latest-news

Regeneron says new clinical data show its investigational gene therapy DB-OTO has restored meaningful hearing in nearly all children treated for rare genetic hearing loss.

LATEST NEWS

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Tvardi’s Lung Disease Drug Falls Short in Trial

Tvardi Therapeutics says its experimental drug TTI-101 failed to show benefit in a Phase 2 clinical trial for idiopathic pulmonary fibrosis.

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Regeneron Gene Therapy Improved Rare Hearing Loss

Regeneron says new clinical data show its investigational gene therapy DB-OTO has restored meaningful hearing in nearly all children treated for rare genetic hearing loss.

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FDA Approves Celltrion’s Eylea Biosimilar

FDA approves Celltrion’s Eydenzelt (aflibercept-boav), a biosimilar referencing Regeneron and Bayer’s blockbuster Eylea for treating several major retinal diseases.

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Cybersecurity Alert on Abiomed Impella Controllers

FDA issues an early alert after Abiomed notified customers about a device correction for its Automated Impella Controller due to a cybersecurity issue.

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Animal Drugs

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medical-devices
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10/9 Vaccines Panel to Recommend Flu Strain Selection

FDA schedules a 10/9 Vaccines and Related Biological Products Advisory Committee meeting to make recommendations on the strain selection for influenza...

medical-devices
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Capsida Pauses Gene Therapy Trial After Death

Capsida Biotherapeutics stops enrollment in its SYNRGY clinical trial that is evaluating gene therapy CAP-002 for treating STXBP1 developmental and ep...

medical-devices
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Guide on Biosimilar Formal Meeting Requsts

FDA releases a final guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.

medical-devices
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Sumitomo Pharma Gets Fast Track Status for Nuvisertib

FDA grants Sumitomo Pharma a fast-track designation for nuvisertib (TP-3654) for treating patients with intermediate or high-risk myelofibrosis.

Biologics

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medical-devices
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Regeneron Gene Therapy Improved Rare Hearing Loss

Regeneron says new clinical data show its investigational gene therapy DB-OTO has restored meaningful hearing in nearly all children treated for rare ...

medical-devices
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FDA Approves Celltrion’s Eylea Biosimilar

FDA approves Celltrion’s Eydenzelt (aflibercept-boav), a biosimilar referencing Regeneron and Bayer’s blockbuster Eylea for treating several major ret...

medical-devices
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Prasad Puts Together CBER Leadership Team

CBER director Vinay Prasad orchestrates leadership changes at the Center, appointing several new acting deputy directors and reassigning key staff.

medical-devices
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New Life Medical Selling Unapproved HCT/Ps

FDA warns Lutz, FL-based New Life Medical Services that it is illegally marketing unapproved human cells, tissues, and cellular and tissue-based produ...

FDA General

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medical-devices
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GOP Senators Call on FDA to Restrict Generic Mifepristone

Fifty-one Republican senators urge FDA to restrict access to abortion pills following the agency’s recent approval of a new generic version of mifepri...

medical-devices
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Public Rating of FDA, Others Dropping

A Gallup Poll shows that Americans’ ratings of FDA and many other federal agencies have dropped in the last year to at or near their lowest point.

medical-devices
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Makary Outlines ‘Mission Critical’ Ops Under Shutdown

FDA commissioner Marty Makary tells employees affected by the government shutdown that the agency will continue mission-critical activities necessary ...

medical-devices
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Sharp Reductions in FDA Operations Under Shutdown: HHS

An HHS contingency plan says FDA would experience sharp reductions in operations if Congress fails to reach a deal to fund the government.

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Federal Register

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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...

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CDER Continues Quality Management Program

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

Human Drugs

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Tvardi’s Lung Disease Drug Falls Short in Trial

Tvardi Therapeutics says its experimental drug TTI-101 failed to show benefit in a Phase 2 clinical ...

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FDA Updates Carvykti Labeling With Boxed Warning

FDA approves new labeling for Janssen Biotech’s Carvykti (ciltacabtagene autoleucel, including a Box...

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Glioblastoma Multiforme Drug Gets Orphan Status

FDA awards Precision NeuroMed an orphan drug designation for IL13-PE38QQR (cintredekin besudotox), a...

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FDA Says Contaminated Cough Meds not in U.S.

FDA says it is monitoring reports of contaminated children’s cough and cold medicines manufactured i...

Marketing

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WLF Wants End to FDA TV Ad ‘Crackdown’

The Washington Legal Foundation calls on the FDA to stop its broad crackdown on drug TV advertising,...

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40 DTC Untitled Letters Posted by FDA

FDA releases 40 cease and desist (untitled) letters to drug companies that the agency said were issu...

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Makary JAMA Piece Explains DTC Ad Crackdown

FDA commissioner Martin Makary pens an online JAMA Viewpoint to explain why the agency is moving to ...

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Bill to Require Drug Price in DTC Ads

Five House members introduce a bill to require DTC television ads to include the drug’s list price.

Medical Devices

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Cybersecurity Alert on Abiomed Impella Controllers

FDA issues an early alert after Abiomed notified customers about a device correction for its Automat...

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SQ Innovation Gets Edema At-Home Treatment OK’d

FDA approves SQ Innovation’s drug-device combination Lasix ONYU (furosemide injection) for treating ...

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Methinks AI Stroke Detection Software Cleared

FDA clears a Methinks AI 510(k) for its Methinks CTA Stroke, an artificial intelligence–based softwa...

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Trividia Recalls 1 Lot of Glucose Meters

FDA says Trividia Health has recalled 601 blood glucose meters that may have defective LCD displays.