Drugs
Cullinan Therapeutics says its partner, Taiho Oncology, has filed an NDA for zipalertinib in combination with platinum-based chemotherapy for treating patients with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations. he submission was made
Drugs
FDA Oncology Center of Excellence director Angelo De Claro says the center has retained its core regulatory experts despite staffing reductions across the agency and is pursuing new collaborations with the Department of Veterans Affairs and National Cancer Institute to modernize oncology clinical trials. Speaking during an 11/10 fireside
Devices
AdvaMed says it is not taking a position on an FDA proposal to reclassify digital breast tomosynthesis systems from Class 3 into Class 2, but does have implementation concerns if the reclassification is approved. In its comment letter, the trade group says, “If FDA finalizes the proposed order, a clear,
enforcement
FDA has posted 20 Form 483 inspection records (see below), including reports involving sterile drug manufacturer Huons in South Korea, Bora Pharmaceutical Laboratories in Taiwan, Genzyme Ireland, Similasan in Switzerland, and medical device manufacturers in the U.S. and overseas. Their availability is part of the agency’s expanded transparency
Devices
Even seemingly modest medical device material changes such as new colorants, a different preservative, or a reformulated component sourced from a new supplier, may require submission of a new 510(k) to FDA. That’s the advice from principal medical device regulation expert Adrienne Lentz (Hyman, Phelps & McNamara) in
FDA Policy/General
Drugs
FDA has effectively shelved former commissioner Marty Makary's Commissioner's National Priority Voucher (CNPV) pilot program, which was promoted to speed selected drug reviews to one or two months. An 11/12 Reuters investigation reported the reversal, following months of criticism from former agency officials, congressional lawmakers
FDA Policy/General
The Senate Health, Education, Labor and Pensions (HELP) Committee has announced an 11/18 vote on President Trump's nomination of Heidi Overton as FDA commissioner, setting up a potentially contentious confirmation effort before Democrats take control of the Senate in January. The White House is reportedly preparing an
FDA Policy/General
Among the many issues facing Congress before the end of the year, it should confirm Heidi Overton as FDA commissioner, according to healthcare strategy and consulting firm Medsecurean founder and CEO Kathleen Jaeger, who previously was CEO of the Generic Pharmaceutical Association (now the Association for Accessible Medicines). Writing in
Drugs
A senior executive of Canadian prescription drug supplier CANARX has been arrested on federal charges involving an alleged scheme to illegally import prescription drugs into the U.S., according to CNBC. John Thomas Howard, the company's treasurer and a director, was arrested Sunday on charges including smuggling, conspiracy,
Independent news and analysis of FDA regulation, policy and enforcement
Two Democratic senators are seeking information from HHS about safeguards against insider trading and other risks associated with prediction markets that allow investors to wager on clinical trial results and FDA drug approval decisions. Sens. Angela Alsobrooks (D-MD) and Ron Wyden (D-OR) raised the concerns in an 11/
Operational challenges for drug companies related to staffing shortages at FDA are unlikely to be resolved in the near term, according to attorney Nathan Downing (Gardner Law), who was interviewed for a PharmaVoice article. The article says CBER and CDER combined had 1,343 fewer employees in September than in
Johnson & Johnson plans to seek FDA approval of Caplyta (lumateperone) for manic episodes associated with Bipolar I disorder following positive results from a second pivotal Phase 3 trial, which demonstrated statistically significant improvements in manic symptoms as early as Day 3. The company said its Study 452 met its
BioNTech says it has entered into an agreement to acquire for $205 million an FDA Priority Review Voucher that was awarded to Scholar Rock. The voucher grants an FDA priority review for a single application, which reduces the target FDA review timeline and could lead to expedited approval. BioNTech says
A new analysis published in Machine Design examines how medical device manufacturers must ensure that engineering design changes are reflected accurately in production records under FDA's Quality Management System Regulation (QMSR). The QMSR, which took effect February 2, 2026, incorporates ISO 13485:2016 into 21 CFR Part 820
FDA says its review of records submitted to it in response to an 11/18/2025 request determined that the Nanjing Hanxin Pharmaceutical Technology Co. in Nanjing Shi, Jiangsu Sheng, China, had a significant deviation from current good manufacturing practice (CGMP) requirements for active pharmaceutical ingredients (APIs). An 11/3
FDA researchers say there have been global efforts to streamline biosimilar development of therapeutic proteins (TPs) by reducing reliance on comparative efficacy studies and moving instead toward a comparative analytic assessment plus pharmacokinetics approach. Writing in the open-source Clinical Pharmacology & Therapeutics, the researchers say the new approach is
FDA's updated operating framework for drug facility inspections makes several procedural changes affecting inspection classifications, remote assessments and the use of foreign regulatory inspection reports, according to an analysis by Hogan Lovells. The revised Concept of Operations (ConOps 2.0) replaces the agency's 2017 framework governing
A 4/7-4/17 FDA inspection at the USV Private Limited drug manufacturing facility in Dabhel, Daman, Dadra and Nagar Haveli and Dam, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 11/2 Warning Letter says the specific violations were: · failure to
BIO says the window to protect America’s biotechnology lead is closing and it offers a seven-step plan to ensure the U.S. remains the global biotech leader for decades to come. In a white paper, “Bio Advance: Securing America’s Biotech Century,” the trade association says the biotechnology
Cingulate says it has resubmitted its NDA for CTx-1301, an investigational treatment for attention-deficit/hyperactivity disorder. The filing addresses issues the agency raised in a June-issued complete response letter, which reportedly were limited to requests for additional chemistry, manufacturing and controls (CMC) information, according to the company.