Drugs
FDA is announcing several actions aimed at accelerating the development of treatments for serious mental illness, following a recent executive order from president Trump that directed federal health agencies to expand access to emerging therapies. The measures include new priority review incentives, clearance of early-stage clinical research, and forthcoming
Drugs
A recent FDA Warning Letter is signaling a broader regulatory focus on how drugmakers use artificial intelligence (AI), according to a new analysis by law firm Morgan Lewis. In a 4/24 blog post, the firm said the agency is moving beyond its earlier oversight of AI as a regulated
Biologics
FDA has issued AbbVie a complete response letter for its BLA for trenibotulinumtoxinE, an investigational, fast-acting botulinum toxin intended for aesthetic use. The agency’s letter focused on manufacturing-related issues and did not cite concerns related to safety or efficacy, according to the company. Importantly, FDA did not
Drugs
FDA has issued an untitled letter to Incyte Corp., warning that portions of the company’s consumer-facing Web site for Niktimvo (axatilimab-csfr) contain false or misleading promotional claims that violate federal law. CDER’s Office of Prescription Drug Promotion (OPDP) says it reviewed the drug’s branded site,
Drugs
FDA sharply expanded enforcement and oversight activities in 2025, issuing hundreds of Warning Letters and targeting a wave of unapproved and counterfeit drugs — particularly popular weight-loss medications — according to a just-released annual report from CDER’s Office of Compliance. The report outlines a year marked by increased regulatory
Biologics
FDA cited multiple manufacturing and quality control concerns at a Swiss drug substance facility operated by Lonza Group, following an inspection in late 2025, according to a just-posted agency inspection report. The findings, detailed in a highly redacted Form 483 issued to the company’s Visp site, identify deficiencies
Drugs
FDA has issued an early alert warning healthcare providers about a potentially dangerous defect in certain angiographic syringes included in medical convenience kits, citing risks that could lead to serious injury or death. The alert highlights a problem involving syringes distributed by Aligned Medical Solutions and manufactured by Medline Industries.
Devices
FDA and CMS have announced a new joint initiative aimed at significantly shortening the time it takes for innovative medical devices to reach Medicare patients, part of a broader push to streamline regulation and expand access to emerging technologies. The newly created Regulatory Alignment for Predictable and Immediate Device (RAPID)
Drugs
FDA has issued Grace Therapeutics a complete response letter rejecting approval for its experimental treatment GTx-104 (nimodipine), citing outstanding manufacturing and non-clinical issues rather than problems with clinical efficacy. The drug is being developed for intravenous infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage patients.
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
Drugs
FDA has released the form FDA-483 with five observations from a 3/9-3/27 inspection at Revive Rx, doing business as Revive Rx Pharmacy, a Houston, TX, producer of sterile and non-sterile drugs. The specific repeat inspection observations were: * microbial contamination was present in the ISO 5
Drugs
FDA has released the form FDA-483, with six observations from a 1/27-2/3 inspection at Global Calcium Pvt. Ltd., an active pharmaceutical ingredient manufacturer in Hosur, India. The specific inspection observations were: * failure of laboratory records to include complete data derived from all tests, examinations, and assays
Devices
Three advocacy groups — Consumers for Dental Choice, Alliance of Nurses for Healthy Environments, and Mercury Policy Project — are petitioning FDA to ban mercury amalgam dental fillings. The 4/16 petition specifically asks the agency to: * ban dental amalgam; * ban the use of dental amalgam at least in high-risk populations,
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
Drugs
FDA commissioner Marty Makary indicated this week that the agency is not planning to eliminate direct-to-consumer (DTC) pharmaceutical advertising, even as it ramps up enforcement against misleading promotions. Speaking at the DTC National conference on 4/21, Makary said the agency does not intend to pursue policies that
Drugs
Two researchers say there are things FDA can do to better use its new plausible mechanism pathway that is expected to increase incentives for drug companies to develop personalized treatments, including gene-editing therapies, for rare disorders. Writing in Nature, the researchers say the bespoke nature of personalized gene therapies
Drugs
Gilead Sciences is petitioning FDA to rescind its decision to file a Cipla 505(b)(2) application for an apparent duplicate of Gilead’s Descovy (emtricitabine and tenofovir alafenamide) tablets. The petition also asks the agency to refuse to grant the Cipla product an A rating, reflecting a determination of
Drugs
FDA has issued a Warning Letter to New Life Pharma citing serious manufacturing and regulatory violations tied to the company’s production of injectable weight-loss and diabetes drugs, including semaglutide- and tirzepatide-based products. Compounding the violations, FDA says the company refused to grant investigators access to certain areas
Drugs
FDA has extended by three months its review of a Sanofi BLA for a subcutaneous formulation of Sarclisa (isatuximab-irfc) for use in combination with standard-of-care regimens for patients with multiple myeloma across all indications currently approved for the drug’s intravenous (IV) formulation. The revised target action
Drugs
FDA has released the form FDA-483 with two observations from the agency’s 3/9-3/11 inspection at Vet4U, a Clay, NY, drug distributor. The specific inspection observations were: * failure to have adequate systems and processes to enable compliance with the verification requirements of section 582(c) of
Drugs
A 4/20 petition submitted by Covington & Burling to FDA on behalf of an unidentified major pharmaceutical company urges the agency to immediately establish a formal process for redacting confidential commercial information and trade secrets before releasing Complete Response Letters (CRLs) for unapproved drug and biologic applications. Historically, the
Drugs
Nineteen Senate Democrats, led by Ron Wyden (D-OR), have introduced legislation aimed at forcing the Trump administration to disclose the terms of agreements it has struck with major pharmaceutical companies, arguing the deals primarily benefit industry rather than patients. The proposal, dubbed the Drug Deal Disclosure Act, would require