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Moderna, at FDA’s urging, voluntarily withdraws a pending BLA for mRNA-1083, its flu/COVID combination vaccine candidate.

latest-news

FDA tells Pfizer and Moderna to strengthen the Warnings in their Covid-19 vaccines related to a possible adverse heart effect in young males.

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Moderna Withdraws Pending BLA for Flu/Covid Vaccine

Moderna, at FDA’s urging, voluntarily withdraws a pending BLA for mRNA-1083, its flu/COVID combination vaccine candidate.

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Expand mRNA Covid Vaccine Warnings: FDA

FDA tells Pfizer and Moderna to strengthen the Warnings in their Covid-19 vaccines related to a possible adverse heart effect in young males.

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Bipartisan Bill to Codify Trump Drug Price Order

Four House members introduce bipartisan legislation to legalize major provisions in President Trump’s drug pricing executive order.

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QS Violations in NeuroSync Inspection

FDA warns Holliston, MA-based NeuroSync about Quality System regulation and other violations in its manufacturing of the Eye-Sync eye assessment medical device.

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Animal Drugs

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medical-devices
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PharmaTher Ketamine NDA Review Extended by FDA

FDA extends by two months its review of a PharmaTher NDA for Ketarx (ketamine) that is seeking anesthesia, sedation, pain, mental health, neurological...

medical-devices
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Taizhou Jingshang Cosmetics CGMP Issues

FDA warns China’s Taizhou Jingshang Cosmetics Technology Co. about CGMP violations in its production of finished drugs.

medical-devices
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Theriva’s Pancreatic Cancer Drug Hits Endpoints

Theriva Biologics reports positive Phase 2b VIRAGE topline results for its VCN-01 when added to standard of care chemotherapy to treat a form of pancr...

medical-devices
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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...

Biologics

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medical-devices
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Moderna Withdraws Pending BLA for Flu/Covid Vaccine

Moderna, at FDA’s urging, voluntarily withdraws a pending BLA for mRNA-1083, its flu/COVID combination vaccine candidate.

medical-devices
Read More
Expand mRNA Covid Vaccine Warnings: FDA

FDA tells Pfizer and Moderna to strengthen the Warnings in their Covid-19 vaccines related to a possible adverse heart effect in young males.

medical-devices
Read More
Covid Vaccine Policy on Boosters and New Trials

FDA commissioner Marty Makary and CBER director Vinay Prasad outline a new regulatory framework for annual Covid-19 booster shots and call for new cl...

medical-devices
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Formycon Wins Stelara Interchangeability for Biosimilar

FDA designates Formycon’s FYB202/Otulfi (ustekinumab-aauz) as an interchangeable biosimilar to Janssen’s reference biologic Stelara (ustekinumab) fo...

FDA General

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medical-devices
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Miller Named Acting Inspections Chief

FDA names Elizabeth Miller acting associate commissioner of the Office of Inspections and Investigations (OII), replacing Michael Rogers, who retired ...

medical-devices
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FDA Policy Head on Major Trump Changes at FDA

FDA deputy commissioner for policy, legislation, and international affairs Grace Graham highlights major changes coming to FDA under the Trump Adminis...

medical-devices
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Makary to Testify at 5/22 Budget Hearing

FDA commissioner Marty Makary agrees to testify 5/22 at a Senate appropriations subcommittee hearing on the agency’s fiscal year 2026 budget request.

medical-devices
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GAO Pushes Its FDA Recommendations to Kennedy

The Government Accountability Office tells HHS secretary Robert F. Kennedy, Jr., about priority recommendations it has made in the past to improve FDA...

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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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Bipartisan Bill to Codify Trump Drug Price Order

Four House members introduce bipartisan legislation to legalize major provisions in President Trump’...

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Panel is Split on UroGen’s Bladder Cancer Drug

FDA’s Oncologic Drugs Advisory Committee offers a split vote on whether UroGen Pharma’s NDA for mito...

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SSRI/SNRI Labeling Changes Sought

The Antidepressant Coalition for Education petitions FDA to change labeling for selective serotonin ...

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FDA Approves Bayer’s Jivi Antihemophilic Factor

FDA expands its approval of Bayer’s Jivi for the routine prophylactic treatment of hemophilia A in p...

Marketing

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FDA Warns Sarfez About Soaanz Promotional Materials

The CDER Office of Prescription Drug Promotion warns Sarfez Pharmaceuticals that promotional materia...

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FDA Hits Mayne Nextstellis Professional Presentation

The CDER Office of Prescription Drug Promotion hits Mayne Pharma over a professional presentation on...

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Odds Low for DTC Ad Ban: Conference Speakers

Speakers at the DTC National conference suggest a ban on drug DTC ads is not very likely.

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Bill Seeks to Kill Tax Deductions for DTC Ad Expenses

A group of bipartisan House lawmakers introduce the No Handouts for Drug Advertisements Act, a bill ...

Medical Devices

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QS Violations in NeuroSync Inspection

FDA warns Holliston, MA-based NeuroSync about Quality System regulation and other violations in its ...

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Ethicon Endo-Surgery Recalls Surgical Stapler

Johnson & Johnson’s Ethicon Endo-Surgery recalls its Endopath Echelon Vascular White Reload for Adva...

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Microspecialties Quality System Issues

FDA warns Middletown, CT-based Microspecialties about Quality System violations in its work as a con...

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Zynex Files 510(k) for CO-Oximeter Device

Zynex files a 510(k) for its NiCO, Noninvasive CO-Oximeter device that relies on the company’s laser...