Drugs
HHS’ Office of Inspector General (OIG) has issued new guidance clarifying when pharmaceutical manufacturers can sell prescription drugs directly to patients enrolled in federal health care programs without violating the federal Anti-Kickback Statute. The guidance comes as direct-to-consumer drug sales have begun to expand, including in connection
Drugs
A 7/14-7/18/2025 FDA inspection at the Fulijaya Manufacturing drug manufacturing facility in Kulim, Kedah, Malaysia, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 1/14 Warning Letter says the specific violations were: * failure to ensure that laboratory records included complete
Drugs
A new Friends of Cancer Research white paper, “Leveraging AI-Enabled Tumor Assessment Tools on Radiological Images to Evaluate Treatment Effect and Support Clinical Trial Endpoints in Solid Tumors,” presents findings from a multi-stakeholder working group it convened to evaluate the current landscape of artificial intelligence (AI)-enabled tumor
Drugs
Roche says its experimental dual GLP-1/GIP receptor agonist CT-388 delivered substantial and statistically significant weight loss in a Phase 2 study of people living with obesity, supporting the drug’s advancement into late-stage development. Topline results from the CT388-103 trial showed that once-weekly subcutaneous
FDA Policy/General
The year 2025 marked a period of significant transformation in FDA and Department of Justice (DoJ) enforcement activities. While traditional priorities around product quality, safety, and clinical research integrity remained central, the enforcement landscape increasingly reflected the current administration’s policy objectives, workforce restructuring, and evolving legal frameworks. A Ropes
Drugs
FDA has lifted a clinical hold on Intellia Therapeutics’ MAGNITUDE-2 Phase 3 trial evaluating nexiguran ziclumeran, or nex-z, for patients with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN), clearing the way for the company to resume patient enrollment and dosing. The gene editing company says FDA removed the
Devices
FDA has issued a Warning Letter to Meridian Bioscience over serious quality system violations involving blood lead testing devices manufactured by its subsidiary, Magellan Diagnostics, underscoring an ongoing regulatory focus on the company’s LeadCare products. The 12/22 warning follows an FDA inspection conducted this past summer at Magellan’
Devices
FDA has issued MAST Biosurgery USA a Warning Letter after an August inspection cited serious manufacturing quality and safety reporting violations related to the company’s SurgiWrap FROST surgical mesh products. The 12/17 letter says the inspection found that the products were adulterated under federal law because the company
Drugs
Drug companies say that while artificial intelligence (AI) still cannot find new molecules that could lead to breakthrough drugs, it is being used to speed up some of the tedious, time-consuming aspects of drug development and application submission. “AI is helping find participants and sites for clinical trials and
Biologics
FDA has approved a Scancell Holdings IND to begin a registrational Phase 3 trial of iSCIB1+, the company’s lead ImmunoBody immunotherapy, in patients with advanced melanoma. The agency agreed that progression-free survival could act as the surrogate primary endpoint, the company says. The late-stage trial is intended
Drugs
A federal judge has sentenced former CytoDyn chief executive Nader Pourhassan to 30 months in prison for misleading investors about the development of an experimental drug for HIV and Covid-19 and selling his personal shares at artificially inflated prices. Between 2018 and 2021, Pourhassan intentionally misled investors about the
Drugs
A newly announced FDA pathway allowing drug approvals based on a “plausible mechanism of action” could accelerate the development of highly individualized treatments for rare genetic diseases, but health policy experts are warning that the approach raises unresolved legal, scientific, and transparency concerns. The pathway for approving certain bespoke, personalized
Biologics
Sarepta Therapeutics is announcing that its gene therapy Elevidys significantly slowed disease progression over three years in ambulatory patients with Duchenne muscular dystrophy, according to topline results from the Phase 3 EMBARK trial. The company says patients treated with Elevidys maintained higher levels of motor function than untreated controls across
Biologics
A coordinated advocacy campaign by the Huntington’s disease community helped set the stage for a high-priority meeting between FDA and uniQure to discuss the regulatory path forward for the company’s experimental gene therapy AMT-130. UniQure said earlier this month that it had secured a Type A
FDA Policy/General
U.S., U.K. and Canadian drug regulators are announcing a 6/2-4 joint international symposium to discuss evolving regulatory expectations for clinical trials, bioequivalence studies and pharmacovigilance, according to a meeting notice posted by FDA. The three-day FDA/MHRA/Health Canada Symposium is expected to draw regulators,
Drugs
FDA has cited Pine Pharmaceuticals for multiple quality and sterility violations following a 10-day inspection of the company’s drug outsourcing facility in Tonawanda, NY, according to a just-released inspection report issued in mid-November. The inspection identified significant deficiencies in the company’s handling of sterile drug
Drugs
FDA says the majority of novel drugs approved in 2025 moved through accelerated regulatory pathways, underscoring the agency’s continued emphasis on speeding patient access to therapies for serious and unmet medical needs. In its just-released annual report, Advancing Health Through Innovation: New Drug Therapy Approvals 2025, CDER says
Drugs
FDA says it continued to improve the speed and consistency of drug manufacturing oversight in fiscal year 2024, citing strong performance under an integrated inspection and facility evaluation framework that has been in place since 2017. According to an FDA summary released this week, the agency met or exceeded key
Drugs
FDA has cited Asahi Kasei Finechem Co. for significant quality control deficiencies following a November inspection of the company’s active pharmaceutical ingredient (API) manufacturing facility in Japan. According to an FDA inspection report, the facility failed to ensure that analytical testing methods used for finished product release met required
Drugs
A broad coalition of healthcare, patient, consumer, and policy organizations is urging Congress to advance legislation that would eliminate the statutory distinction between biosimilars and so-called interchangeable biosimilars, arguing the change would expand patient access and lower healthcare costs. The Biosimilars Council and the Association for Accessible Medicines (AAM)
Drugs
Sanofi says its experimental antibody amlitelimab showed consistent efficacy and a favorable safety profile across multiple late-stage clinical trials in patients with moderate-to-severe atopic dermatitis, paving the way for global regulatory submissions later this year. In the SHORE Phase 3 trial, amlitelimab met all primary and key
Devices
FDA has approved Guardant Health’s Guardant360 CDx liquid biopsy as a companion diagnostic to identify patients with BRAF V600E–mutant metastatic colorectal cancer who may benefit from treatment with Pfizer’s Braftovi (encorafenib) in combination with cetuximab (Lilly’s Erbitux) and chemotherapy. The decision was supported by data from