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The Justice Department says it has reached a deferred prosecution agreement with Veloxis Pharmaceuticals under which the company is paying $46 million to resolve criminal and civil allegations that it paid kickbacks to induce prescriptions of its kidney transplant immunosuppressive drug Envarsus.

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FDA releases the Form FDA-483 with three observations from a 2024 inspection at India’s MSN Life Sciences Unit II active pharmaceutical ingredient manufacturing facility.

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Veloxis Paying $46 Million to Resolve Kickback Charges

The Justice Department says it has reached a deferred prosecution agreement with Veloxis Pharmaceuticals under which the company is paying $46 million to resolve criminal and civil allegations that it paid kickbacks to induce prescriptions of its kidney transplant immunosuppressive drug Envarsus.

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3 Observations in MSN Life Sciences Inspection

FDA releases the Form FDA-483 with three observations from a 2024 inspection at India’s MSN Life Sciences Unit II active pharmaceutical ingredient manufacturing facility.

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New Pathway Sought for Albuterol Inhalation Aerosol Products

A petition submitted to FDA calls for the agency to create conditional nonprescription access to albuterol sulfate inhalers.

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Aquestive Will Resubmit Anophylm NDA in 3rd Quarter

Aquestive Therapeutics says that based on new human factor and pharmacokinetic trials of its Anophylm sought by FDA in a complete response letter, it plans to resubmit the Anophylm NDA in the third quarter of 2026, seeking an indication to treat type 1 allergic reactions.

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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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3 Observations in MSN Life Sciences Inspection

FDA releases the Form FDA-483 with three observations from a 2024 inspection at India’s MSN Life Sci...

motusgi
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New Pathway Sought for Albuterol Inhalation Aerosol Products

A petition submitted to FDA calls for the agency to create conditional nonprescription access to alb...

motusgi
Read More
Aquestive Will Resubmit Anophylm NDA in 3rd Quarter

Aquestive Therapeutics says that based on new human factor and pharmacokinetic trials of its Anophyl...

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NDA for PTSD Therapy Resubmitted

Resilient Pharmaceuticals resubmits an NDA for its midomafetamine capsules for a proposed indication...

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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Hamilton Medical Removes Breathing Circuit Set

An updated Class 1 recall notice says Hamilton Medical is recommending that certain coaxial breathin...

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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...