Drugs
An FDA review of records submitted by Zydus Lifesciences Limited in Solan, Himachal Pradesh, India, in response to an FDA 11/7/2025 request, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/2 Warning Letter says the specific violations were: * failure to withhold
Drugs
An 11/3-11/7/2025 FDA inspection at the Hubei Gedian Humanwell Pharmaceutical Co. drug manufacturing facility in Ezhou City, Hubei Province, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 6/3 Warning Letter says the specific deviations were: * failure
Drugs
FDA has documented GMP issues at a long-troubled Bloomington, IN, fill-finish facility — formerly owned by Catalent and acquired by Novo Nordisk in late 2024 — according to a Form 483 issued following an April reinspection. The Catalent facility was hit last year with a Warning Letter that cited significant
Drugs
Disc Medicine says it has reached agreement with FDA on a potential regulatory path forward for its investigational therapy bitopertin, with the agency indicating that a successful Phase 3 (APOLLO) trial could support a response to the drug's recent complete response letter and potentially lead to traditional approval
Drugs
Two Republican senators have introduced legislation that would establish a distinct regulatory framework for homeopathic medicines at FDA, a move supporters say would preserve consumer access to alternative therapies while critics are likely to scrutinize provisions that exempt such products from traditional drug approval requirements. Senators Mike Lee (R-UT)
Drugs
Eli Lilly is reporting detailed Phase 3 results Monday showing its oral GLP-1 receptor agonist Foundayo (orforglipron) outperformed Novo Nordisk's oral semaglutide on blood sugar control and weight loss in what the company described as the first head-to-head late-stage trial comparing two oral GLP-
FDA Policy/General
Delegates at the American Medical Association's (AMA) annual meeting have voted to support stronger FDA oversight of synthetic peptide products, citing growing concerns about the widespread use of unapproved compounds marketed for weight loss, wound healing, longevity, and other health claims without robust clinical evidence. Peptides — short chains
Drugs
FDA has placed a clinical hold on the Quantum BioPharma IND for Lucid-21-302, the company’s drug candidate to treat multiple sclerosis. According to a Quantum statement, the hold is pending submission of additional information requested by FDA. Quantum says it is reviewing FDA’s comments and will
Drugs
Eight Mintz attorneys say a recent unanimous Supreme Court decision makes clear that “skinny label” generic drug manufacturers do not induce patent infringement by simply complying with industry practice and equating the generic drug to the reference drug. In Hikma Pharmaceuticals USA v. Amarin Pharma, the court held that Amarin,
FDA Policy/General
FDA's expanding use of artificial intelligence tools in regulatory operations is poised to transform how pharmaceutical, biotechnology, and medical device companies prepare for and manage inspections, according to a new analysis by former FDA Office of Enforcement director David Elder. In a guest column published on pharmaceuticalonline.com,
Drugs
FDA officials are seeking to bolster confidence in generic medicines, highlighting the agency's oversight of drug manufacturing, inspection programs and post-market surveillance while promoting new efforts to expand domestic pharmaceutical production. In a joint FDA Voices commentary, CDER Office of Generic Drugs director Iilun Murphy and CDER
Drugs
FDA is launching a new effort to aggregate clinical trial data on kidney safety biomarkers, seeking pharmaceutical industry participation in a pilot program that could ultimately broaden the agency's use of novel a "biomarker incubator," a regulatory science initiative designed to collect and analyze biomarker data
Devices
FDA has issued an early alert warning healthcare providers about a potentially high-risk defect affecting certain infant resuscitation systems manufactured by GE HealthCare, citing concerns that the devices may deliver incorrect oxygen concentrations to newborn patients. The alert follows a company notice advising users to inspect and, if necessary,
FDA Policy/General
Pharmaceutical Research and Manufacturers of America (PhRMA) is calling on FDA to provide clearer regulatory expectations for the use of digital health technologies in drug development, arguing that adoption has lagged despite years of agency guidance and industry investment. In comments submitted to an FDA request for information on advancing
Drugs
FDA has approved an expanded indication for Pfizer's hemophilia treatment Hympavzi (marstacimab-hncq), allowing its use in additional patient populations that have historically faced limited treatment options, according to the company. The approval extends use of the once-weekly injectable therapy to patients aged 12 years and older
Drugs
FDA has issued a draft guidance outlining post-approval responsibilities facing manufacturers of generic drugs, highlighting requirements ranging from adverse event reporting and drug shortage notifications to labeling updates, promotional material submissions and compliance with Risk Evaluation and Mitigation Strategies (REMS). A major portion of the guidance focuses on pharmacovigilance
FDA Policy/General
Drug manufacturers, patient advocates and policy experts used the first FDA public hearing on the Commissioner’s National Priority Voucher (CNPV) program to urge the agency to temporarily suspend the initiative and establish a more transparent framework governing its operation. The 6/4 hearing marked the first formal opportunity for
FDA Policy/General
The House, Thursday evening, passed FDA’s appropriations bill for fiscal year 2027 that provides $7.1 billion for the agency, including $3.4 billion in discretionary budget authority and $3.7 billion in authorized user fees. The measure was approved by a vote of 213 to 210. Meanwhile, Senate
Drugs
FDA has issued Xspray Pharma a complete response letter for the company's NDA for Nilopki, an improved formulation of nilotinib designed to compete with Novartis' chronic myeloid leukemia (CML) therapy Tasigna. FDA told the company that it is unable to approve the application in its current form,
Devices
FDA says its breakthrough devices program has surpassed 1,280 designations since its launch, highlighting the growing use of the expedited pathway by medical device developers seeking to bring innovative technologies to patients with serious or life-threatening diseases. According to updated figures released by FDA, the agency had granted
Biologics
FDA has approved a Lupin BLA for Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar to Genentech's blockbuster eye drug Lucentis. Ranluspec references Lucentis, a vascular endothelial growth factor (VEGF) inhibitor widely used in ophthalmology to treat vision-threatening retinal diseases. The biosimilar is approved for the same major indications
Drugs
With radiopharmaceutical therapies projected to expand greatly, some manufacturers are raising issues about inconsistent FDA actions through the Radiopharmaceutical Manufacturers and Therapeutic Alliance (RMTA), a trade group that evolved this year from the Medical Imaging Technology Alliance’s PET Working Group. An online AuntMinnie.com post says uneven FDA inspections