Biologics
FDA has accepted for priority review a Bristol Myers Squibb supplemental BLA for Opdivo (nivolumab) and its use in combination with AVD chemotherapy for adults and adolescents with previously untreated Stage III or IV classical Hodgkin lymphoma. The agency set a user fee review action date of 4/8/2026.
Devices
An Eagle Hill Consulting independent assessment of FDA’s Total Product Lifecycle Advisory Program (TAP) pilot found it “demonstrates exceptional performance across all key metrics, indicating strong progress toward achieving its outcomes.” The conclusion is in the 12/2025 Final Assessment Report, based on information from 95 TAP innovators and
Devices
FDA has approved the first at-home, prescription-only brain-stimulation device to treat major depressive disorder. Flow Neuroscience says its FL-100 system, a transcranial direct current stimulation (tDCS) device, is designed for adults with moderate to severe depression. It is intended as a stand-alone intervention or as
Devices
Rep. Jan Schakowsky (D-IL) and Sen. Dick Durbin (D-IL) have reintroduced legislation they say will improve the medical device recall process to protect patients. In a statement, Schakowsky says the Medical Device Recall Improvement Act would: * require FDA to establish an electronic format for medical device recall notifications;
Drugs
Serina Therapeutics says it has filed a complete response to an FDA clinical hold issued 11/25 on SER-252, the company’s lead investigational therapy for advanced Parkinson’s disease. The hold was placed after the agency requested additional information about a commonly used formulation excipient. The agency did
FDA Policy/General
FDA is weighing changes to a long-standing labeling rule for dietary supplements and will temporarily exercise enforcement discretion as it evaluates industry requests to do so, the agency said in a 12/11 letter to industry. At issue is a requirement in 21 CFR 101.93(d) that mandates
Biologics
A 6/2-6/6 FDA inspection at Lux Therapeutics, doing business as Ponya Therapeutics, in Brookhaven, GA, documented significant violations of the regulations for human cells, tissues, and cellular and tissue-based products (HCT/P). An 11/25 Warning Letter says the specific violations were: * failure to validate and
Devices
FDA has cleared a Lumos Labs 510(k) for LumosityRx, a prescription digital therapeutic intended to improve attention in adults (ages 22 to 55) with attention-deficit/hyperactivity disorder. The mobile app adapts 13 cognitive training games into a regulated therapeutic module designed to target cognitive processes tied to attention.
Drugs
Roche says results from the Phase 3 lidERA breast cancer study evaluating its investigational giredestrant as adjuvant endocrine treatment for people with estrogen receptor-positive, human epidermal growth factor receptor 2-negative early-stage breast cancer showed the treatment significantly reduced the risk of invasive disease recurrence or death by
Devices
Former FDAer Daniel McMullen, who most recently was director of the CDRH Office of Neurological and Physical Medicine Devices, the agency unit responsible for the total lifecycle review of medical devices such as Neuralink’s brain implant, has joined Neuralink to lead its medical affairs division. The appointment was reported
Drugs
The U.S. government has asked the Supreme Court to take up a patent-infringement dispute between generic drugmaker Hikma Pharmaceuticals USA, Inc. and brand-name company Amarin to decide whether generic drugmakers may face liability for inducement of patent infringement when they market a drug under a so-called
Drugs
Researchers from several universities say the enhanced safety-related regulatory authorities in the FDA Amendments Act (FDAAA) of 2007 were not associated with differences in time to first postmarket safety-related action. Writing in JAMA Internal Medicine, the researchers said (subscription required) that among therapeutics with postmarket safety-related actions
Drugs
The Washington Legal Foundation (WLF) is cautioning that the Trump administration’s ongoing crackdown on direct-to-consumer (DTC) pharmaceutical advertising is on a collision course with First Amendment protections. In a new Legal Backgrounder, WLF senior litigation counsel Zac Morgan argues that the agency’s recent wave of Warning
Drugs
FDA has approved Italian non-profit Fondazione Telethon’s BLA for Waskyra (etuvetidigene autotemcel), the first gene therapy for Wiskott-Aldrich syndrome (WAS), a rare, life-threatening immune disorder. Approved for children as young as six months and for adults with confirmed WAS gene mutations, Waskyra is intended for patients
Biologics
Children’s Health Defense (CHD), which was co-founded by now-HHS secretary Robert F. Kennedy, Jr., is petitioning FDA to take several actions against the mRNA Covid-19 vaccines produced by Moderna and Pfizer/BioNTech. The petition specifically asks that the agency: * revoke all BLAs for every mRNA Covid-
Biologics
FDA is signaling a major policy shift for cancer CAR T-cell therapies, moving away from reliance on single-arm studies toward randomized controlled trials (RCTs) that demonstrate superiority over existing treatments. Writing in a new JAMA Perspective piece, CBER director Vinay Prasad and other Center officials say that many
Drugs
Four Hogan Lovells attorneys say that recent Department of Justice (DoJ) subpoenas and the so-called Hsiao Declaration “signal a potential redefinition of enforcement boundaries under the Federal Food, Drug, and Cosmetic Act (FFDCA). By asserting that off-label prescribing may itself constitute an FFDCA violation and that scientific exchange
Drugs
A 5/18-6/18 FDA inspection at the Seaway Pharma drug manufacturing facility in Massena, NY, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 12/1 Warning Letter says the specific violations were: * failure to establish adequate written responsibilities and procedures applicable to
Drugs
FDA has approved Augmentin XR (amoxicillin–clavulanate potassium) through the new Commissioner’s National Priority Voucher (CNPV) pilot program, permitting new U.S.-based production capacity at a domestic facility. This is the first product approved under the initiative aimed at strengthening U.S. drug manufacturing and supply chain resilience.
Drugs
CDER has published a Manual of Policies and Procedures (MAPP), “Prescription to Nonprescription Switches and Abbreviated New Drug Applications,” describing the policies and procedures for the Office of Generic Drugs (OGD) when a reference-listed drug switches from prescription to nonprescription marketing status. The MAPP specifically describes the procedures for
Drugs
FDA says it has qualified the AI-Based Histologic Measurement of NASH (AIM-NASH), the first artificial intelligence (AI) drug development tool, intended to help pathologists assess metabolic dysfunction-associated steatohepatitis (MASH) disease activity in clinical trials. An agency announcement says the cloud-based tool helps pathologists score liver biopsy
Drugs
FDA has released a final guidance entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers,” which is aimed at clarifying how pharmaceutical companies should promote prescription biologics, including biosimilars and interchangeable biosimilars, in advertising and labeling. The guidance, presented