FDA Policy/General
President Trump has reportedly signed off on a plan to remove FDA commissioner Marty Makary from his post, according to multiple media reports published Friday, potentially setting up another major leadership shakeup at the agency less than 14 months into the Trump administration’s second term. The Wall Street Journal
FDA Policy/General
Atara Biotherapeutics says it and partner Pierre Fabre Pharmaceuticals have received feedback from FDA outlining a potential path toward resubmitting their BLA for tabelecleucel, an investigational T-cell therapy for Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). The companies recently held a Type A meeting with the
FDA Policy/General
FDA commissioner Marty Makary is reportedly in the White House’s crosshairs and could be removed from his post in the coming weeks as the Trump administration weighs a broader shakeup of key personnel, according to a 5/6 report published by journalist Rachael Bade on her Substack. Citing unnamed
FDA Policy/General
Pharmaceutical advertising experts joined the Food and Drug Law Institute’s annual conference in Washington, DC 5/6 to share their reactions to FDA’s dramatically altered enforcement approach toward prescription drug promotion since last fall, creating new uncertainty for industry as the agency ramps up scrutiny of direct-to-
FDA Policy/General
FDA has launched a pilot program using one-day inspectional assessments as part of a broader effort to modernize its oversight model and deploy inspection resources more efficiently. The initiative is intended to introduce shorter, targeted facility reviews designed to complement, rather than replace, the agency’s traditional, multi-day
FDA Policy/General
FDA is facing mounting internal strain and external criticism just over a year into commissioner Marty Makary’s tenure, according to accounts from agency staff, industry executives and policymakers, raising questions about leadership stability at the nation’s top drug regulator. Makary, initially viewed as a conventional and well-qualified
FDA Policy/General
FDA has issued an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a consumer-facing Web site for its drug Amvuttra. In the letter, CDER’s Office of Prescription Drug Promotion said the Amvuttra Web page overstated the drug’s survival benefit in patients with transthyretin amyloid cardiomyopathy
FDA Policy/General
The Pharmaceutical Research and Manufacturers of America (PhRMA) is urging FDA to broaden and clarify its draft guidance on individualized therapies, warning that overly narrow definitions and unclear expectations could hinder innovation in precision medicine. In formal comments submitted on the agency’s proposed “plausible mechanism” framework, PhRMA called for
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a YouTube video and Spanish-language TV ad for Bayer’s Nubeqa (darolutamide) tablets for oral use are misleading because they include claims and representations about the drug’s benefits but omit important risk information associated with it. A 4/28
FDA Policy/General
The U.S. House Appropriations Committee on Tuesday approved legislation to fund FDA for fiscal year 2027, advancing the measure to the full House after a largely party-line vote. The Agriculture/FDA spending bill cleared the committee 4/29 by a vote of 35–25, according to congressional materials.
FDA Policy/General
Purdue Pharma was sentenced 4/28 in federal court in Newark, NJ, to pay more than $5 billion in criminal penalties for its role in the U.S. opioid epidemic. The penalties include a $3.544 billion criminal fine and $2 billion in forfeiture, though up to $1.775 billion
FDA Policy/General
Insulet has recalled (Class 1) certain insulin pump components, warning that continued use could result in severe injury or death. The recall affects specific lots of the company’s Omnipod 5 Pods, a wearable device used to deliver insulin continuously for people with diabetes. According to an FDA notice, Insulet
FDA Policy/General
FDA is moving to modernize how clinical trials are conducted, unveiling a pair of proof-of-concept studies and outlining plans for a broader pilot program aimed at enabling real-time data sharing between sponsors and regulators. In a 4/28 announcement Tuesday, the agency says two early-stage “real-
FDA Policy/General
Galaxy Therapeutics has submitted the final module of a PMA for its SEAL device, a treatment designed for patients with wide-neck bifurcation brain aneurysms. The filing completes the company’s modular PMA submission, a regulatory pathway that allows device makers to submit sections of an application incrementally. The SEAL
FDA Policy/General
Concerns that political pressure could undermine the U.S. drug approval system are intensifying this week after a new White House directive on psychedelic therapies appears to be steering FDA toward accelerated reviews (see earlier story) — prompting warnings from public health experts about risks to scientific integrity. Former FDA associate
FDA Policy/General
A Clinical Trial Vanguard online column says the Supreme Court’s decision in Loper Bright, which ended courts’ deference to federal agency interpretations under the earlier Chevron decision, is affecting the way that FDA attempts to regulate synthetic biology, “a field that routinely produces organisms, materials, and therapeutics that no
FDA Policy/General
FDA has approved a Regeneron Pharmaceuticals BLA for Otarmeni (lunsotogene parvec-cwha), the first gene therapy for a form of inherited hearing loss. The dual adeno-associated virus (AAV) vector-based gene therapy is indicated for patients with severe-to-profound sensorineural hearing loss caused by mutations in the OTOF
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
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
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-
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