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
Drugs
Six King & Spalding attorneys say the over 200 drug advertising and promotion enforcement letters FDA issued in 2025 hit a nearly-25-year high. Writing in an online blog post, the attorneys say the vast majority of the letters were issued after the agency’s 9/9/2025 announcement
Drugs
Corcept Therapeutics says its experimental drug relacorilant met the overall survival primary endpoint in a pivotal Phase 3 trial in patients with platinum-resistant ovarian cancer, marking a key milestone as an NDA for the therapy is under review. The company says the ROSELLA trial showed that patients treated with
Drugs
FDA has released the form FDA-483 with six observations from a 9/8-9/16/2025 inspection at the Lupin sterile manufacturing facility in Nagpur, Maharashtra, India. The observations were: * failure of procedures designed to prevent microbiological contamination of drug products purporting to be sterile to include adequate validation
Drugs
FDA has granted Opna Bio an orphan drug designation for its investigational treatment OPN-2853 (zavabresib), a small-molecule bromodomain and extra-terminal motif inhibitor, for myelofibrosis, which is characterized by progressive scarring of the bone marrow and leading to impaired blood cell production and symptoms that can include severe
Drugs
Nearly half of drug shortage announcements led to protective purchasing intended to safeguard patient access, according to a report in the United States Pharmacopeia online Quality Matters newsletter. While protective purchasing is intended to preserve patient access, the report says, it can have the unintended consequence of deepening supply disruptions
Drugs
FDA has released the form FDA-483 issued following an 11/13-11/21/2025 inspection at the Sato Pharmaceutical over-the-counter sterile and non-sterile drug manufacturing facility in Hachioji, Tokyo, Japan. The 10 specific inspection observations were: * failure to thoroughly review any unexplained discrepancy and the failure
Drugs
IntraBio is reporting positive results from a pivotal Phase 3 clinical trial showing that levacetylleucine significantly improved neurological symptoms in patients with ataxia-telangiectasia, a rare and progressive neurodegenerative disease with no approved treatments. The trial met its primary endpoint, the company says, demonstrating a statistically significant and clinically meaningful
Drugs
FDA says it will start accepting applications on 2/1 for the PreCheck Pilot Program, which it says is intended to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability, facilitating the construction of U.S. manufacturing sites, and streamlining aspects of pharmaceutical manufacturing facility assessments before a specific
Drugs
Four stakeholder organizations are voicing basic support for an FDA draft guidance, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies. Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports a “totality of the evidence” approach to determining whether
Drugs
Cogent Biosciences says FDA has agreed to accept the company’s planned NDA for cancer drug bezuclastinib under the agency’s Real-Time Oncology Review program, based on positive late-stage trial results in patients with gastrointestinal stromal tumors (GIST). The company will seek approval for the therapy and its
Drugs
FDA is touting upcoming actions to encourage moving more medications from prescription-only status to over-the-counter (OTC) availability, a shift the agency says could lower drug prices, reduce unnecessary emergency room visits, and streamline access to common treatments. In an interview with The Daily Wire, FDA commissioner Marty
Drugs
FDA says its ImportShield Program, formerly known as the Nationalized Entry Review Program, increased processing speed by 66%, increased monthly volume capacity by 33%, and reduced staff hours by 20%, all in its first four months of operation (since 8/2025). An agency statement says the new program “streamlines FDA’
Drugs
Novo Nordisk has submitted to FDA its second supplement to its nomination of semaglutide products (Ozempic and Wegovy) to the list of drug products that present demonstrable difficulties for compounding under the Federal Food, Drug, and Cosmetic Act (FFDCA). “This supplement adds to the body of evidence that demonstrates the
Drugs
A 12/17/2024-1/10/2025 FDA Bioresearch Monitoring Program inspection of the Temecula, CA, Prodrome Sciences USA clinical investigation of Omega-3 plasmalogens found objectionable conditions indicating that the company did not adhere to laws and regulations governing the conduct of clinical investigations and the protection of human
Drugs
FDA has released a draft guidance outlining how drug developers can use minimal residual disease (MRD) and complete response (CR) as primary endpoints in multiple myeloma trials to support accelerated approval, a move that could further speed access to new treatments in a disease area where outcomes have steadily improved.
Drugs
FDA has published for review and comment an International Council for Harmonization guidance, The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality, M4Q(R2), establishing the location and structure of quality information for registration applications of all medicinal products for human use. The document says it
Drugs
A 6/16-6/24/2025 FDA inspection at the Integrity Partners Group’s Chemisphere drug manufacturing facility in St. Louis, MO, identified four current good manufacturing practice (CGMP) regulation violations in the firm’s production of finished drugs. A just-released 12/15/2025 Warning Letter says the specific
Drugs
FDA has accepted for priority review a Celcuity NDA for gedatolisib in patients with hormone receptor–positive, HER2-negative, PIK3CA wild-type advanced breast cancer. The company says the submission is based on data from the PIK3CA wild-type cohort of Celcuity’s Phase 3 VIKTORIA-1 trial, which evaluated
Drugs
FDA inspectors cited Oklahoma-based outsourcing facility Qualgen for a wide range of manufacturing and quality control failures during a recent inspection, including inadequate controls to prevent cross-contamination of hazardous drugs and repeated lapses previously flagged by the agency. According to an FDA Form 483 issued at the conclusion