NDA Filed for Zipalertinib in Lung Cancer

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 on Digital Breast Tomosynthesis Reclassification

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,

Modest Device Material Change May Need New 510(k): Post

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

Senate HELP Committee Plans 11/18 Vote on Overton FDA Nomination

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

Confirm Overton Now: Kathleen Jaeger

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

FDA Probe Leads to Arrest of Canadian Drug Importation Executive

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,

Makary Confirms Allegations of Industry Pressure on FDA

Senators Press HHS on Prediction Markets Tied to Drug Approvals, Clinical Trials

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/

Industry Affected by FDA Staff Shortage: Article

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

J&J Plans FDA Filing for Caplyta in Bipolar Mania After New Data

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 Agrees to Buy Priority Voucher for $205 Million

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

FDA's QMSR Places New Emphasis on Device Design Changes: Analysis

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