Drugs
FDA is asking all manufacturers of generic drugs citing Accutane (isotretinoin) as the reference-listed drug. An agency statement says the updates are necessary “because new scientific evidence exists that is not reflected in current labeling, and the approved labeling does not follow the current format that better serves healthcare
Biologics
FDA has reversed course and has told UniQure that data from its ongoing Phase I/II study of AMT-130 could serve as the primary basis for a BLA seeking accelerated approval for the investigational Huntington's disease gene therapy. The regulatory feedback was provided during a recent Type
Drugs
FDA and the African Medicines Agency (AMA) have signed a Statement of Cooperation establishing a formal framework for collaboration between the U.S. regulator and Africa's continental medicines agency. The agreement is intended to strengthen regulatory convergence, information sharing, and harmonization efforts as the AMA continues to build
Biologics
FDA has accepted for review a BLA resubmission from Outlook Therapeutics seeking approval of ONS-5010/Lytenava (bevacizumab-vikg) for treating neovascular age-related macular degeneration, commonly known as wet AMD. The filing focuses on the review of product labeling and represents what the company described as the final step
FDA Policy/General
Two Mintz attorneys say recent leadership changes at FDA, coupled with many executive-level vacancies, have affected the priorities started by former commissioner Marty Makary. Writing in the one-year anniversary edition of their firm’s FDA in Flux newsletter, the attorneys say the leadership changes coincided with an immediate
FDA Policy/General
A coalition of 65 health, environmental, consumer, farming, and animal welfare organizations has filed a citizen petition urging FDA to withdraw approvals for the routine use of medically important antibiotics for disease prevention in food-producing animals. The petition argues that widespread antibiotic use in livestock contributes to the growing
Drugs
An FDA review of records requested by the agency on 7/7/2025 from Sante Manufacturing in Aylmer, Ontario, Canada, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs in the firm’s manufacturing of over-the-counter drug products. A 6/5 Warning Letter says
Drugs
North Dakota State University economics professor Raymond March says there is a clear reason why FDA struggles to provide effective risk management guidance and seems to flounder when asked to manage risk for others: it can’t. Writing for the Independent Institute in an online post, March argues that “risk
Drugs
Ochsner MD Anderson Cancer Center system medical director of precision medicine Marc Matrana is calling on FDA to require a labeling change for immunotherapies used to treat non-small cell lung cancer involving a Limitation of Use to exclude patients with ROS Proto-Oncogene 1, Receptor Tyrosine Kinase (“ROS1”) and
Devices
Draeger has expanded a 10/2024 device correction (Class 1 recall) to include additional Atlan A350 and A350XL anesthesia workstations used in operating rooms and other procedural settings. The devices are used to deliver inhaled anesthesia and provide both automatic and manual ventilation for adult, pediatric, and neonatal patients. According
Drugs
FDA has issued a Warning Letter to Greek contract manufacturer Pharmathen International citing significant GMP violations at its sterile drug manufacturing facility in Sapes, Greece, including deficiencies in aseptic processing, contamination control, quality investigations, facility design, and data integrity. The just-posted 5/27 letter follows an FDA inspection conducted
Biologics
An FDA briefing document released in advance of a 6/18 advisory committee meeting reviewing Moderna's investigational mRNA influenza vaccine, mFlusiva (mRNA-1010), reveals a more favorable outlook than many observers expected after a February Refusal-to-File letter was issued and then reversed shortly thereafter. That application
Drugs
FDA says there is an implementation delay for isotretinoin iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) modifications. The modifications were scheduled to go into effect 8/8, but the planned implementation date has been changed to 11/15 because more time is needed to test iPLEDGE REMS system updates, minimize
Devices
A 2/27-4/5/2025 FDA inspection at the Zoll Medical facility in Chelmsford, ME, found Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of an automated external defibrillator, ventilator, and electrodes and sensors. A just-released 4/30 Warning Letter says the specific
Drugs
A physician has asked FDA to impose an immediate moratorium on the use of gadolinium-based contrast agents in MRI scans, arguing that a growing body of scientific literature demonstrates the agents can cause widespread and potentially permanent health effects. In a just-posted citizen petition, Regina Sutton called on
Drugs
FDA has authorized Colorado's prescription drug importation program, marking another step forward for state-led efforts to lower drug costs through imports from Canada under Section 804 of the Federal Food, Drug, and Cosmetic Act. In a 6/15 letter, the agency said the state's revised
FDA Policy/General
FDA and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) have unveiled a new liaison program designed to strengthen collaboration between the two regulators on medicines, medical devices and emerging technologies, including artificial intelligence. The initiative, announced Monday at the DIA Global Annual Meeting in Philadelphia, will
Drugs
Eli Lilly is reporting positive Phase 3 results for its BTK inhibitor Jaypirca (pirtobrutinib) in combination with venetoclax and rituximab, showing a significant progression-free survival benefit in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). The BRUIN CLL-322 trial met its primary
Drugs
While FDA’s recently introduced Plausible Mechanism Framework is designed to accelerate development of individualized therapies for rare disease patients, significant operational hurdles remain before the approach can be broadly implemented, according to a commentary published 6/15 by Steven Ringel, founder and chief executive of Nome Therapeutics. The framework
Drugs
FDA is escalating its scrutiny of telehealth companies marketing compounded drugs, warning that some firms are making false or misleading claims about compounded GLP-1 weight-loss treatments and other medications that could mislead patients and violate federal law. An FDA notice notes that the agency has issued Warning Letters
Drugs
Neumora Therapeutics says it is discontinuing development of its lead depression candidate navacaprant after two Phase 3 studies failed to meet their primary and key secondary endpoints in patients with major depressive disorder (MDD). The company is reporting that both the KOASTAL-2 and KOASTAL-3 trials failed to demonstrate
Drugs
Jazz Pharmaceuticals says its Phase 3 LAGOON study evaluating Zepzelca (lurbinectedin) in relapsed small cell lung cancer (SCLC) failed to meet its primary endpoint of overall survival, raising questions about the future of the drug's second-line indication. The global trial, sponsored by Jazz partner PharmaMar, evaluated Zepzelca