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President Trump signs an executive order directing the federal government to develop what the White House calls "Gold Standard Childhood Vaccine Recommendations," reducing the number of diseases for which routine childhood immunization is recommended.

latest-news

Tenax Therapeutics says its oral levosimendan candidate TNX-103 failed to meet the primary endpoint in a Phase 3 trial evaluating the treatment in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction.

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Trump Orders Changes to Childhood Vaccine Recommendations

President Trump signs an executive order directing the federal government to develop what the White House calls "Gold Standard Childhood Vaccine Recommendations," reducing the number of diseases for which routine childhood immunization is recommended.

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Tenax’s TNX-103 Misses Primary Endpoint in Phase 3 Trial

Tenax Therapeutics says its oral levosimendan candidate TNX-103 failed to meet the primary endpoint in a Phase 3 trial evaluating the treatment in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction.

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ITM Receives FDA Complete Response Letter for Radiopharmaceutical

FDA sends ITM Isotope Technologies Munich SE a Complete Response Letter (CRL) for its investigational radiopharmaceutical for gastroenteropancreatic neuroendocrine tumors.

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FDA Flags Abiomed, Oscor Correction of Impella Catheter Introducers

Abiomed and manufacturing partner Oscor issue a correction (Class 1 recall) for certain catheter introducers used with Impella heart pumps after identifying a potential for leakage that could result in serious bleeding.

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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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Moderna Wins Approval for mRNA Flu Vaccine

FDA approves a Moderna BLA for mFLUSIVA (mRNA-1010), a new influenza vaccine for use in all adults 50 years and older.

medical-devices
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FDA Accelerated Approval for Replimune Melanoma Therapy

FDA grants acelerated approval to Replimune for its Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy, in comb...

medical-devices
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Allergan sBLA for Botox Accepted for Review

FDA accepts for review an Allergan Aesthetics supplemental BLA for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance...

medical-devices
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Draft Guidance on Biosimilar Container Closure Design

A new FDA draft guidance outlines how sponsors should develop and evaluate container closure systems and device components used with biosimilar and in...

FDA General

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medical-devices
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Trump Administration Weighs Executive Order on Autism, Vaccines

The Trump administration considers an executive order addressing vaccines and autism as soon as next week.

medical-devices
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FDA Posts User Fee Rates for FY 2027

FDA posts the following user fee rates for medical product programs for fiscal year 2027.

medical-devices
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Dr. Oz Emerges as Potential Successor to RFK Jr. at HHS, Report Says

Bloomberg reports that Centers for Medicare & Medicaid Services head Mehmet Oz is increasingly viewed inside the Trump administration as the leading c...

medical-devices
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FDA Moving to a ‘Shared Services’ and Inspections Approach

NOTUS reports that FDA will reorganize on 10/1 to a “shared services” model in which administrative functions are centralized, and inspectors are gene...

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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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Trump Orders Changes to Childhood Vaccine Recommendations

President Trump signs an executive order directing the federal government to develop what the White ...

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Read More
Tenax’s TNX-103 Misses Primary Endpoint in Phase 3 Trial

Tenax Therapeutics says its oral levosimendan candidate TNX-103 failed to meet the primary endpoint ...

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Read More
ITM Receives FDA Complete Response Letter for Radiopharmaceutical

FDA sends ITM Isotope Technologies Munich SE a Complete Response Letter (CRL) for its investigationa...

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FDA Flags Abiomed, Oscor Correction of Impella Catheter Introducers

Abiomed and manufacturing partner Oscor issue a correction (Class 1 recall) for certain catheter int...

Marketing

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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...

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Friendly Accelerated Approval Disclosures Improve Drug Understanding: Study

A new study suggests that direct-to-consumer prescription drug Web sites may better communicate the ...

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DTC Advertising Industry Braces for Potential End of Adequate Provision

DTC Perspectives CEO Bob Ehrlich warns that an upcoming FDA proposal to eliminate the adequate provi...

Medical Devices

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Panel to Review Next-Gen Cancer Detector Test

FDA's announces a 9/23 advisory committee meeting to vote on a Grail PMA for the Galleri test and it...

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AdvaMed Strongly Backs MDUFA 6 Agreement

AdvaMed voices strong public support for the MDUFA 6 commitment reached with FDA.

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Device Regulators Guide on Change Control Plans for Device Software

The International Medical Device Regulators Forum releases a final document outlining global princip...

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Quality System Issues at Koven Technologies

FDA warns St. Louis, MO-based Koven Technologies about QSMR issues in its manufacturing and marketin...