Drugs
FDA has accepted for review a Sun Pharmaceutical Industries supplemental BLA seeking to expand the use of Ilumya (tildrakizumab-asmn) to treat adults with active psoriatic arthritis. If approved, the new indication would extend the use of the IL-23 inhibitor beyond its current authorization for moderate-to-severe plaque
Drugs
Telix Pharmaceuticals has resubmitted an NDA seeking approval of its investigational PET imaging agent Pixclara (TLX101-Px, also known as 18F-FET) for evaluating recurrent or progressive glioma. The company says the resubmission includes additional data and statistical analyses requested by the agency after it issued a complete response letter
FDA Policy/General
FDA sharply increased enforcement activity against drugmakers and distributors in fiscal year 2025, issuing 303 Warning Letters to companies involved with drugs and biologics — up 59% from 190 letters in FY2024 — according to a new analysis from consulting firm Eliquent Life Sciences. The report, authored by regulatory experts Erin Hartmann
FDA Policy/General
Several emerging regulatory and enforcement developments at FDA are expected to have significant implications for pharmaceutical, medical device, and digital health companies in 2026, according to a new legal update from ArentFox Schiff. The report highlights intensifying FDA enforcement activity, evolving regulatory frameworks, and growing litigation risks tied to agency
Biologics
CBER director Vinay Prasad’s departure at the end of next month is raising questions across the biotechnology sector about how the agency’s approach to vaccines, gene therapies and rare-disease treatments could change in the months ahead. Prasad has had a tumultuous tenure that lasted less than a
Drugs
Questions are emerging about the long-term impact of the Commissioner’s National Priority Voucher (CNPV) program, with some policy experts warning the program could expose the agency’s approval process to legal challenges and regulatory uncertainty. The initiative, launched last June by FDA commissioner Marty Makary, offers selected drug
Devices
Insulet has initiated a Class 1 device correction for certain lots of its Omnipod 5 Automated Insulin Delivery System pods after identifying a manufacturing issue that could affect insulin delivery, according to an FDA notice. Some pods from specific lots may contain a small tear in the internal tubing used
Drugs
FDA has approved Novartis’ Cosentyx (secukinumab) for treating adolescents aged 12 and older with moderate to severe Hidradenitis Suppurativa, expanding the drug’s use into another pediatric indication. The decision makes Cosentyx the only interleukin-17A inhibitor approved in the U.S. for adolescents with the painful inflammatory skin disorder
Biologics
FDA has expanded the approved use of GSK’s Arexvy, a respiratory syncytial virus (RSV) vaccine that now includes the in adults aged 18 to 49 who are at increased risk of severe disease. The vaccine was previously authorized for preventing RSV-related lower respiratory tract disease (LRTD) in adults
Biologics
FDA’s Vaccines and Related Biological Products Advisory Committee has voted to recommend that seasonal influenza vaccines for the 2026–2027 U.S. season use a trivalent formulation, targeting two influenza A strains and one influenza B strain. Panel members voted 7–0 in favor of recommended strains for both
Drugs
Eli Lilly has issued a “public warning” about potential safety risks associated with compounded tirzepatide (Mounjaro and Zepbound) with vitamin B12. A company statement says Lilly tested compounded products being marketed to Americans that contain tirzepatide combined with B12, sometimes referred to as methylcobalamin, hydroxcobalamin, or cyanocobalamin. It says the
Drugs
BridgeBio Pharma says its investigational therapy BBP-418 showed consistent clinical benefit and a favorable safety profile in an interim analysis of the Phase 3 FORTIFY trial in patients with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), a rare and progressive genetic muscle disorder with no approved treatments.
Devices
FDA has approved Johnson & Johnson’s Tecnis PureSee Intraocular Lens, a new extended depth-of-focus lens for use in cataract surgery, giving surgeons a new option designed to improve visual range while maintaining strong visual quality. According to Johnson & Johnson, the lens is the first FDA-approved
Drugs
A 3/2026 FDA draft guidance, New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers, outlines the agency’s approach to determining new clinical investigation exclusivity. In an online post, attorneys Aziz Burgy and Aaron Savit (Axinn) say the draft guidance also suggests some strategies for
Drugs
Academic researchers say FDA should continue modernizing its foreign inspection framework, ensuring that high-import-volume mutual recognition agreement countries such as Ireland receive scrutiny proportional to their market share, and developing additional metrics to assess whether the unannounced inspection mandate translates into measurable improvements in oversight rigor. Writing in
Devices
FDA has released a draft guidance entitled Medical Devices with Indications Associated with Weight Loss - Premarket Considerations outlining recommendations for companies developing devices intended to support weight management or weight loss, and detailing the types of information manufacturers should include in premarket submissions. The guidance applies to several categories of
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
FDA Policy/General
FDA has launched its new FDA Adverse Event Monitoring System (AEMS), a searchable new platform for analyzing adverse event reports. An agency statement says AEMS “represents a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.” According to FDA commissioner
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-