Drugs
FDA has granted Acadia Pharmaceuticals a Fast Track designation for remlifanserin, an investigational, highly selective, 5-HT2A receptor inverse agonist for treating hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). Acadia says enrollment has been complete in the company’s Phase 2 RADIANT study that is evaluating remlifanserin
Drugs
InnoDev Partners consultants Gail McIntyre and Michelle Usher say the biopharma industry could benefit from re-embracing the 505(b)(2) approval pathway under which sponsors may draw on previous findings around an existing drug even as they propose modifications to it. Writing in a BioSpace column, McIntyre and Usher
Drugs
China approved more novel oncology drugs than the U.S. between 2020 and 2025, with its annual approval totals surpassing FDA’s beginning in 2023, according to a new analysis published in Health Affairs Scholar by Friends of Cancer Research. The analysis found that China's National Medical Products
Biologics
FDA has accepted for priority review a Dyne Therapeutics BLA for zeleciment rostudirsen for treating individuals with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. The company says it has requested accelerated approval based on dystrophin as a surrogate endpoint. The agency set a user fee review action target
Drugs
A Nevada businessman has pleaded guilty to importing and distributing misbranded prescription erectile dysfunction drugs from India, generating more than $1.9 million in online and retail sales, federal prosecutors say. The case was investigated by FDA's Office of Criminal Investigations and the U.S. Postal Inspection Service.
Drugs
A new study published in JAMA Health Forum suggests the market for compounded GLP-1 weight-loss drugs remains robust despite the FDA's resumption of enforcement against copies of commercially available products following the end of semaglutide and tirzepatide shortages. Researchers conducted a "secret shopper" survey
FDA Policy/General
FDA and the Department of Justice are increasingly extending enforcement actions beyond traditional drug manufacturers to telehealth platforms, online marketplaces, compounders and other companies involved in distributing FDA-regulated products, according to a former DOJ official. During an episode of the FDA Watch podcast, Gabriel Scannapieco, a partner at Arnold
FDA Policy/General
A 7/20 realclearhealth.com opinion article contends that FDA acting commissioner Kyle Diamantas has outlined a broad vision for modernizing the agency by emphasizing innovation, artificial intelligence, advanced manufacturing, and supply chain resilience while maintaining the agency's traditional standards for safety and effectiveness. The commentary, written by
Devices
FDA has issued an Early Alert warning healthcare providers about a potentially high-risk issue involving certain Baxter Duo-Vent solution sets that could allow air to enter a patient's intravenous line under specific conditions. The agency said Baxter has notified affected customers and is recommending that certain
Drugs
FDA has cited Fujifilm Diosynth Biotechnologies USA for significant manufacturing deficiencies at its drug substance facility in Research Triangle Park, NC, raising concerns about microbial contamination controls, environmental monitoring and investigations into repeated contamination events, according to a Form FDA 483 issued following a March inspection. The inspection came on
Drugs
FDA has accepted for review a Camurus NDA resubmission for Oclaiz (octreotide), a long-acting injection for treating acromegaly. The agency has set a user fee review action target date of 12/18. Last month, FDA issued a second complete response letter (CRL) to the Swedish biotechnology company that was
Devices
FDA has classified as Class 1 a Bolton Medical recall of its Relay Pro Thoracic Stent Graft Systems due to reports of a deployment failure that may result in serious injury or death. The company recently issued a device removal notice on specific device configurations, instructing healthcare providers to immediately
Drugs
FDA is taking issue with Charles River Laboratories' Endosafe contract testing laboratory in Charleston, SC, over multiple quality system deficiencies following a March inspection that found inadequate controls over laboratory operations, equipment calibration, deviation management, complaint handling and investigation procedures. A just-posted Form FDA 483 lists a single
FDA Policy/General
A new study suggests that direct-to-consumer prescription drug Web sites may better communicate the limitations of FDA accelerated approvals when disclosures use consumer-friendly language rather than technical wording drawn from physician labeling. The study, published 7/15 in Therapeutic Innovation & Regulatory Science, examined whether the presence,
Drugs
FDA has released the form FDA-483 issued following a 4/29-5/8 inspection at Alvotech EF, a biological drug substance/product manufacturer in Reykjavik, Iceland. The specific inspection observations were: * procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed;
Devices
A Minnesota federal judge has ruled in favor of FDA and Medtronic in three of four spinal cord stimulator (SCS) lawsuits. MassDevice reports online that the suits claimed that the Medtronic SCS systems implanted in four patients caused damage. The judge ruled that all claims from three of the four
Drugs
The latest iteration of the CDER Guidance Agenda projects that the Center will issue 85 new or revised guidances in CY 2026. The guidances are in these 14 categories: * administrative/procedural (8 guidances) * artificial intelligence (2) * biosimilars (6) * biostatistics/clinical/medical (2) * clinical/medical (9) * clinical pharmacology (5) * compounding (8)
Drugs
FDA has approved Merck's Lipfendra (enlicitide) 20 mg tablets as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including patients with heterozygous familial hypercholesterolemia (HeFH), marking the first approval of an oral proprotein convertase subtilisin/kexin type 9
FDA Policy/General
Quasi betting platform Kalshi has launched a pilot program allowing traders to buy and sell contracts tied to the outcomes of late-stage clinical trials and FDA regulatory decisions, creating what the company says will be the first publicly available, continuously updated probabilities for drug development milestones. The initiative, announced
Drugs
FDA has released the form FDA-483 with 13 observations from a 4/13-4/24 inspection at the Zhejiang Hushai Pharmaceutical Co. drug manufacturing facility in Zhejiang, China. The inspection observations were: * failure to make written records of investigations into unexplained discrepancies or the failure of a batch or
Drugs
The American Society of Health System Pharmacists (ASHP) says the 227 active drug shortages in the second quarter of 2026 represent an increase for the third consecutive quarter but remain significantly lower than the all-time high of 323 shortages in the first quarter of 2024. The ASHP report says
Drugs
Rep. Diana DeGette (D-CO) took FDA to task recently, winning assurances from the agency that several policy announcements issued during former commissioner Marty Makary's tenure — including articles published in medical journals and media interviews — are not intended to be recognized as official agency guidance. During a 4/