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FDA issues Alar Pharmaceuticals an untitled letter over promotional materials for its investigational ketamine drug, ALA-3000, because they improperly portrayed the unapproved drug as safe and effective.

latest-news

FDA’s approval of new drugs is increasingly being supported by fewer clinical studies.

LATEST NEWS

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FDA Hits Alar Pharmaceuticals Experimental Ketamine Promotion

FDA issues Alar Pharmaceuticals an untitled letter over promotional materials for its investigational ketamine drug, ALA-3000, because they improperly portrayed the unapproved drug as safe and effective.

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Study Finds Drug Approvals Increasingly Rely on Fewer Trials

FDA’s approval of new drugs is increasingly being supported by fewer clinical studies.

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Alert on Boston Scientific’s Angiographic Catheters

FDA issues an Early Alert after becoming aware that Boston Scientific sent a letter to customers recommending all Imager II Angiographic Catheters be removed from where they are used or sold.

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FDA OKs Lilly's Mounjaro to Reduce CV Risk in Adults with Diabetes

FDA approves Eli Lilly’s Mounjaro (tirzepatide) for lowering the risk of major adverse cardiovascular events.

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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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FDA Approves Updated Covid-19 Vaccines for Upcoming Season

FDA approves updated Covid-19 vaccines from Moderna, Pfizer-BioNTech and Novavax/Sanofi for the upcoming vaccination season.

medical-devices
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FDA Approves First Drug for Warm Autoimmune Hemolytic Anemia

FDA approves a Janssen Biotech BLA for Imaavy (nipocalimab-aahu) injection for warm autoimmune hemolytic anemia in adult and pediatric patients.

medical-devices
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Jemperli sBLA for Rectal Cancer Accepted for Priority Review

FDA accepts for priority review a GSK supplemental BLA for Jemperli (dostarlimab) for certain patients with previously untreated Stage II and III loca...

medical-devices
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HHS Seeks Input on Categories of Federal Vaccine Recommendations

HHS seeks input on how the federal government classifies vaccine recommendations, including whether its current system gives patients and parents enou...

FDA General

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medical-devices
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HHS to Appoint 2 New FDA Deputy Commissioners: CNBC

CNBC reports that HHS plans to appoint two new FDA deputy commissioners in hopes of exerting more influence over the agency.

medical-devices
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Webinar on FDA’s Bayesian Draft Guidance

FDA announces a 10/14 Webinar on its recent draft guidance on Use of Bayesian Methodology in Clinical Trials of Drugs and Biologics.

medical-devices
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Commissioner Pick Faces Potentially Lengthy Senate Confirmation

Senate confirmation of FDA commissioner nominee Heidi Overton appears to be getting some resistance and a quick Senate confirmation seems unlikely.

medical-devices
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Trump Picks Health Policy Adviser Overton as FDA Commissioner Nominee

President Donald Trump selects White House health policy adviser Heidi Overton as his nominee to become FDA commissioner.

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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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Study Finds Drug Approvals Increasingly Rely on Fewer Trials

FDA’s approval of new drugs is increasingly being supported by fewer clinical studies.

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FDA OKs Lilly's Mounjaro to Reduce CV Risk in Adults with Diabetes

FDA approves Eli Lilly’s Mounjaro (tirzepatide) for lowering the risk of major adverse cardiovascula...

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First Oral Drug Indicated to Treat Dermatomyositis Approved

The agency approves Priovant Therapeutics’ Lisraya (brepocitinib) tablets for treating dermatomyosit...

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Senate Report Raises Questions About Oversight of Mifepristone Providers

A new report from Senate HELP chair Bill Cassidy (R-LA) targets FDA for allowing the abortion drug m...

Marketing

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FDA Hits Alar Pharmaceuticals Experimental Ketamine Promotion

FDA issues Alar Pharmaceuticals an untitled letter over promotional materials for its investigationa...

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FDA Promotion Crackdown Enters New Phase: Attorneys

Attorneys from Arnall Golden Gregory examine and offer advice on FDA’s intensified scrutiny of drug ...

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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...

Medical Devices

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Alert on Boston Scientific’s Angiographic Catheters

FDA issues an Early Alert after becoming aware that Boston Scientific sent a letter to customers rec...

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QMSR Finding Single Risk Thread: Report

MasterControl issues its 2026 life sciences regulatory readiness playbook demonstrating the signific...

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Boston Scientific ENROUTE System Recall is Class 1

FDA says the Boston Scientific recall of its ENROUTE Transcarotid Neuroprotection System is Class 1.

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FDA Issues Alert on Abiomed Impella Controllers

CDRH issues an early alert to notify the public about an Abiomed action recommending that all Automa...