Biologics
FDA has issued Summit Therapeutics a complete response letter (CRL) on its BLA for ivonescimab in combination with platinum-containing chemotherapy for treating patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), who have received prior epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy. Ivonescimab
FDA Policy/General
FDA Policy/General
Former CDC Director Robert Redfield is urging the Senate to confirm Heidi Overton as FDA commissioner before the end of the year, arguing that prolonged uncertainty over the agency's leadership could undermine U.S. competitiveness in biotechnology and threaten national health security. In a recent opinion article, Redfield
enforcement
FDA posted five Form 483 inspection records involving three manufacturers, including Dr. Reddy's Laboratories in India and Qingdao Kangyuan Pharmaceutical in China, according to the agency's Office of Inspections and Investigations FOIA Electronic Reading Room. The newly published records include a June 25, 2026, inspection of
enforcement
FDA investigators cited JOINN Laboratories (Suzhou) Co., a Chinese nonclinical testing laboratory, for deficiencies involving specimen tracking, laboratory procedures and animal housing facilities during a 5/11-15 inspection. The agency issued a two-observation Form 483 to the laboratory, located in Taicang, Jiangsu Province, identifying problems with compliance with
Biologics
FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with Pfizer and Astellas Pharma’s Padcev (enfortumab vedotin-ejfv) as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after radical cystectomy (RC), for treating adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for or who
Drugs
Interrupting treatment with certain lung cancer drugs may have a greater adverse effect on efficacy than reducing their dosage, according to a new analysis by FDA researchers published in Clinical Cancer Research. The researchers examined patient-level data from clinical trials supporting the original FDA approvals of four epidermal growth
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
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
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
Independent news and analysis of FDA regulation, policy and enforcement
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
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,
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
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
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
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,
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