Devices
FDA has rejected a citizen petition seeking to withdraw approval of Covidien’s VenaSeal vein-closure system, concluding the medical device remains safe, effective and appropriately regulated under existing law. In a detailed response, the agency said the petition failed to provide sufficient scientific or legal grounds to revoke the
Drugs
FDA has approved an expanded indication for Sanofi’s Tzield (teplizumab), allowing its use in children as young as one year old to delay the onset of stage 3 Type 1 diabetes. The decision broadens Tzield’s previous U.S. approval, which covered patients aged eight and older with stage
Drugs
An 8/12-8/16/2025 FDA inspection at the Xiamen Kang Zhongyuan Biotechnology Co. drug manufacturing facility in Fujian Sheng, China, found its products are adulterated due to being prepared, packed, or held under insanitary conditions. A just-released 3/23 Warning Letter says the company did not have
Drugs
Two University of Pittsburgh pharmacy professors say FDA’s new Adverse Event Monitoring System (AEMS) dashboard was launched with a consequential omission. Writing in a column in The Scientist, the professors say FDA “launched a powerful public-facing tool without building in the infrastructure to help people understand what the
Biologics
FDA has accepted a Roche supplemental BLA that seeks to expand use of Gazyva to treat Systemic Lupus Erythematosus (SLE). The agency is expected to make a decision by December. If approved, Gazyva, which is already approved for lupus nephritis, could become the first anti-CD20 therapy specifically indicated for
Drugs
FDA commissioner Marty Makary says the agency will deploy its new “national priority voucher” program to significantly shorten drug review timelines for three psychedelic therapies at the center of president Donald Trump’s executive order signed over the weekend (see earlier story). The vouchers could reduce review periods to roughly
FDA Policy/General
FDA has approved Merck’s Idvynso, a once-daily, single-tablet regimen for adults with HIV-1 who are already virologically suppressed. The therapy combines doravirine and islatravir and is indicated as a replacement regimen for patients with HIV-1 RNA levels below 50 copies per milliliter who are stable
FDA Policy/General
Outlook Therapeutics says it has completed a formal dispute resolution meeting with FDA as part of the company’s push to revive its approval prospects for ONS-5010, also known as LYTENAVA (bevacizumab-vikg), following a regulatory setback late last year. The meeting with CDER’s Office of New Drugs
Drugs
A 7/21-7/24/2026 FDA inspection at the University of California at San Francisco (UCSF) radiopharmaceutical drug manufacturing facility in San Francisco, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/13 Warning Letter says the specific violations were: * failure to
Drugs
A 10/6-10/20/2025 FDA inspection at the Par Health USA/Endo USA drug manufacturing facility in Rochester, MI, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/15 Warning Letter says the specific violations were: * failure to perform operations within specifically
FDA Policy/General
FDA says it will expand efforts to reduce animal testing in drug development after reporting significant first-year progress under its roadmap to modernize nonclinical studies, with upcoming steps focused on scaling alternative methods, improving data infrastructure, and tightening global coordination. In a new report, Reducing Animal Testing in Nonclinical
Drugs
President Trump has signed a sweeping executive order aimed at accelerating the development and availability of psychedelic-based treatments for patients with serious mental illness, directing federal agencies to streamline regulatory pathways, expand research funding, and improve patient access to investigational therapies. The order places significant new responsibilities on FDA
FDA Policy/General
FDA has accepted for priority review a Pfizer and Astellas Pharma supplemental BLA for Padcev (enfortumab vedotin-ejfv) that seeks to expand use of a combination regimen for patients with muscle-invasive bladder cancer (MIBC). The application covers Padcev’s perioperative use in combination with Merck’s Keytruda, a PD-
Drugs
FDA has issued updated guidance clarifying how patients, physicians, and drug developers can access investigational therapies outside of clinical trials, incorporating policy changes enacted under recent federal laws. The document, Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers, reflects the agency’s latest thinking on so-called
Drugs
Nektar Therapeutics is reporting new 52-week data from its mid-stage REZOLVE-AA trial, showing continued improvement in hair regrowth among patients with severe-to-very-severe Alopecia areata treated with its investigational therapy rezpegaldesleukin. The results come from a 16-week blinded extension of the Phase 2b study,
Drugs
FDA has told Passage Bio that a randomized controlled trial will be required to support approval of its experimental gene therapy for a rare form of dementia, raising the regulatory bar as the company evaluates the future of the program. The feedback, delivered during a recent Type C meeting, means
Devices
FDA has cleared a Philips 510(k) for its new Spectral CT Verida system, marking the U.S. debut of what the company describes as the first AI-powered detector-based spectral CT scanner. The device integrates always-on spectral imaging with artificial intelligence – driven image reconstruction, aiming to improve
Drugs
FDA has released a draft guidance outlining how drugmakers should establish impurity specifications for antibiotics produced by fermentation and semi-synthetic processes, aiming to standardize quality expectations for a complex class of medicines. The CDER document provides recommendations for identifying, testing and setting acceptance criteria for impurities and degradation products
FDA Policy/General
FDA has issued a draft guidance outlining a proposed compliance policy that could ease certain premarket requirements for respirators already approved by National Institute for Occupational Safety and Health, signaling a shift toward reduced regulatory burden for widely used protective devices. The draft document covers a range of air-purifying
Drugs
FDA has granted Opna Bio a fast track designation for its investigational therapy OPN-6602 and its use in treating patients with relapsed or refractory multiple myeloma who have undergone at least four prior lines of therapy. The oral small-molecule inhibitor targeting EP300 and CREB-binding protein is currently
FDA Policy/General
U.S. Sen. Susan Collins (R-ME) used a Senate hearing 4/16 to spotlight barriers to lower-cost drugs, pressing an expert witness on delays in bringing generics and biosimilars to market and promoting her own legislative proposals aimed at reducing prices. During a Senate Health, Education, Labor, and
Drugs
Since 2021, the FDA Satellite Laboratory Branch of the National Forensic Chemistry Center in the Office of the Chief Scientist has analyzed and helped to block two million lot units (capsules and tablets) of illegal, counterfeit, and other unsafe drug and medical products from reaching U.S. consumers and patients.