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
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
FDA Policy/General
FDA has classified a correction involving certain ventilators manufactured by Philips as a Class I recall, warning that continued use of the devices without recommended updates could lead to serious injury or death. The action affects multiple models in the Philips Respironics Trilogy Evo platform, including Trilogy Evo, Trilogy EV300,
FDA Policy/General
President Donald Trump has nominated Dr. Erica Schwartz, a former deputy surgeon general in the first Trump administration, who spent 24 years in the U.S. Public Health Service Commissioned Corps and also was a Coast Guard rear admiral, to the post of director of the Centers for Disease Control
FDA Policy/General
Eli Lilly says it will seek expanded FDA approval by the end of the quarter for its obesity drug Foundayo (orforglipron) as a treatment for diabetes, following positive topline results from its Phase 3 ACHIEVE-4 trial. The company said the oral GLP-1 receptor agonist met its primary cardiovascular
FDA Policy/General
FDA was a recurring point of reference during a 4/16 House budget hearing featuring HHS secretary Robert F. Kennedy Jr., as lawmakers pressed the administration on drug regulation, approval timelines, and the broader competitiveness of U.S. biomedical policy. While the hearing was centered on HHS budget priorities and
FDA Policy/General
A senior FDA official is poised to play a key role in a potential leadership overhaul at the Centers for Disease Control and Prevention, as the White House weighs naming president Trump’s former deputy U.S. surgeon general Erica Schwartz as director, according to multiple reports. Sarah Brenner, currently
FDA Policy/General
FDA has issued an updated compliance program that standardizes how inspectors evaluate manufacturing facilities tied to biologic drug applications, reinforcing a risk-based approach to oversight while tightening timelines for communication and follow-up. The program, released 4/14 and set to take effect 5/14, outlines procedures for pre-
FDA Policy/General
CDER has issued two Manuals of Policies and Procedures (MAPP) on postmarketing requirements. MAPP 6010.9 Rev. 1, Procedures and Responsibilities for Developing Postmarketing Requirements and Commitments, applies to the development of all reportable 506B postmarketing commitments (PMCs) for drugs and licensed biological products regulated by CDER, and the communication
FDA Policy/General
A new policy analysis from the Cato Institute is calling on FDA to modernize its regulatory framework for artificial intelligence (AI) in healthcare, arguing that current rules are slowing innovation and discouraging companies from developing high-impact medical tools. In the 4/13 blog post, authors Christopher Gardner and Kevin
FDA Policy/General
Representative Jake Auchincloss (D-MA) is urging FDA whistleblowers to come forward to disclose instances of wrongdoing by agency managers. “FDA Commissioner Marty Makary’s incompetence and poor stewardship are undermining the Food and Drug Administration,” Achincloss says in a video posted on X. “Multiple former senior FDA officials have
FDA Policy/General
The homepage of the consumer Web site for BioCorRx Pharmaceuticals’ Lucemyra (lofexidine) tablets for oral use is false and misleading, according to a 3/27 Untitled Letter issued by the CDER Office of Prescription Drug Promotion (OPDP). The letter says the homepage includes a claim that Lucemyra is the only
FDA Policy/General
Attorneys Charles Snow and Dara Levy (Hyman, Phelps & McNamara) say a bipartisan effort led by Sens. Richard Durbin (D-IL) and Roger Marshall (R-KS) to push FDA to take a more positive role in early review of prescription drug direct-to-consumer ads, coupled with heightened FDA enforcement
FDA Policy/General
HHS secretary Robert F. Kennedy Jr. has been told by the White House to tone down and curtail his public commentary on vaccines as part of a deliberate political strategy by the Trump administration, according to a newly revealed internal memo reported by Bloomberg. The memo outlines a “low-risk