FDA Policy/General
FDA commissioner Marty Makary says the artificial intelligence (AI) tools the agency has implemented have saved its 14,000 staffers some 17,000 hours of human work time in the measurement period the agency has assessed since implementation at the end of 6/2025. In an online interview with Healthcare
Drugs
Senator Ron Johnson (R-WI) is launching a congressional investigation into FDA’s recent decisions to reject or delay treatments for rare diseases, escalating political scrutiny of the agency’s regulatory standards and decision-making. Johnson, who chairs the Senate Permanent Subcommittee on Investigations, said he is seeking copies of
Drugs
FDA has approved Bristol Myers Squib’s Sotyktu (deucravacitinib), an oral therapy for treating adults with active psoriatic arthritis. The approval expands the drug’s use beyond plaque psoriasis and introduces the first tyrosine kinase 2 (TYK2) inhibitor authorized for patients with psoriatic arthritis, a chronic autoimmune condition that causes
FDA Policy/General
Newsweek says FDA “has faced an unusual convergence of political, scientific, legal and operational pressure in recent months, as it balances public health demands with intensifying scrutiny from the White House, Congress, industry and patient advocates.” The magazine details four major issues that it says have plagued the agency in
Drugs
FDA has posted the Form 483 behind a 3/5 Warning Letter (see story) to Novo Nordisk that cited serious violations of postmarketing adverse drug experience reporting requirements. According to an FDA Form 483 issued 2/7, investigators found that the company failed to submit more than 300 required “15-
Drugs
An 8/14-8/22/2025 FDA inspection at the Tentamus India Private Limited contract testing laboratory in Hyderabad, Telangana State, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/3 Warning Letter says the specific violations were: * failure of the firm’s
Drugs
FDA has posted a 3/5 complete response letter to Rosemont Pharmaceuticals, rejecting the company’s NDA for valacyclovir. The agency cited GMP deficiencies documented in a recent manufacturing facility inspection. According to the letter, the sponsor must submit an updated safety analysis that incorporates new clinical and nonclinical data
Drugs
Vertex Pharmaceuticals says an interim analysis of its Phase 3 RAINIER trial showed its experimental therapy povetacicept significantly reduced proteinuria and improved other disease markers in adults with IgA nephropathy, positioning the drug candidate for a potential U.S. accelerated approval filing this month. At 36 weeks, patients treated with
Drugs
FDA has accepted for review a Capricor Therapeutics BLA resubmission for its experimental cell therapy deramiocel, intended to treat heart complications in patients with Duchenne muscular dystrophy. FDA classified the filing as a Class 2 resubmission and set a new user fee review action target date of 8/22. The
Drugs
FDA has approved an expanded use of GSK’s Wellcovorin (leucovorin calcium) tablets for treating cerebral folate deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (CFD-FOLR1). The approval fell short of agency and HHS expectations communicated in September that hinted
Drugs
A 9/18-9/26 FDA inspection at the Simtra BioPharma Solutions drug manufacturing facility in Westphalia, Germany, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/3 Warning Letter says the specific violations were: * failure to perform operations within specifically defined areas of
Drugs
A 1/13-2/7/2025 FDA inspection at the Novo Nordisk facility in Plainsboro, NJ, identified serious violations of postmarketing adverse drug experience (PADE) reporting requirements. A 3/5 Warning Letter cites several examples of how Novo Nordisk failed to develop written procedures for the surveillance, receipt, evaluation, and
Drugs
An 8/4-8/12/2025 FDA inspection at the Fareva drug manufacturing facility in Morton Grove, IL, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/3 Warning Letter says the three specific violations were: * failure to use equipment in the manufacture, processing,
Drugs
Consumer advocacy group Public Citizen is pressing Pfizer to commit to maintaining access to its medicines in Europe after comments by CEO Albert Bourla suggesting the company could stop supplying drugs to France if governments refuse to pay higher prices. In a letter sent Monday, the group demanded that Pfizer
Drugs
Roche is reporting that its investigational breast cancer drug giredestrant failed to significantly extend progression-free survival in a Phase 3 study when combined with the CDK4/6 inhibitor palbociclib (Pfizer’s Ibrance), dealing a setback to the company’s effort to establish the therapy in first-line metastatic disease.
Drugs
FDA says it recently held a meeting with several states to discuss implementation of a program that would allow the importation of certain lower-cost prescription drugs from Canada. The discussions focused on the Section 804 Importation Program, which permits states and Native American tribes to seek authorization to import
Drugs
Xenon Pharmaceuticals says its experimental epilepsy drug azetukalner met the primary endpoint in a late-stage clinical trial in patients with focal onset seizures, paving the way for a planned U.S. regulatory filing later this year. Topline results from the Phase 3 X-TOLE2 study showed the drug significantly
Drugs
Ipsen is voluntarily withdrawing Tazverik (tazemetostat) from the market based on emerging data from the ongoing Phase 1b/3 SYMPHONY-1 trial that is evaluating the therapy in combination with lenalidomide plus rituximab in follicular lymphoma. The trial’s independent data monitoring committee advised that based on adverse events of
Drugs
FDA investigators have cited manufacturing and documentation issues at an Indian sterile drug facility operated by Maiva Pharma Private Ltd. following an inspection last month, according to an inspection report issued by the agency. The inspection, conducted from 2/10-20 at the company’s plant in Hosur in the
Drugs
An FDA official discussing an ongoing dispute this week with UniQure over its gene therapy for Huntington’s disease (see story) also raised concerns with outside experts who sit on agency advisory committees. The official, who spoke on condition of anonymity, criticized the advisory committees, suggesting some outside experts “do
Drugs
Acting on behalf of an “interested client,” a Buchanan petition asks FDA to take immediate administrative and enforcement action against 503B outsourcing facilities distributing adulterated and misbranded ophthalmic Bevacizumab products. The petition asks FDA specifically to: * issue an order and/or formal guidance clarifying that compounded ophthalmic bevacizumab products do
Drugs
Senate Select Committee on Aging chairman Rick Scott (R-FL) and ranking member Kirsten Gillibrand (D-NY) have contacted CVS, Walgreens, and Walmart with additional questions about their efforts to safeguard the integrity of the U.S. drug supply chain. The letter commends the three companies for their “proactive efforts