Drugs
FDA has published a guidance, Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations, with recommendations for sponsors planning to conduct food effect studies for orally administered drug products as part of INDs or NDAs and supplements to those applications. The document revises part of
Drugs
Reps. Eric Sorensen (D-IL) and Stephanie Bice (R-OK) have introduced the Stop Games Act, which they say would crack down on tactics used by drug companies to block cheaper generic drugs from entering the market. A statement issued by Sorensen’s office says the bill would crack down
Devices
Implantica says it has submitted the final response to FDA on its PMA for RefluxStop that addresses the agency’s remaining questions tied to Module 3 of the submission and includes additional testing that followed a previously disclosed 100-Day Meeting. Implantica said the FDA has now completed reviews of
Devices
FDA has granted Valar Labs a breakthrough device designation for its Vesta Bladder Risk Stratify Dx test, an artificial intelligence-powered digital pathology tool designed to help predict outcomes for bladder cancer patients. The company says the test is designed for use in patients with non-muscle-invasive bladder cancer,
Devices
FDA has approved Guardant Health’s next-generation Guardant360 Liquid CDx, a blood-based comprehensive genomic profiling test designed to provide both genomic and epigenomic insights for patients with advanced cancer. The company says the newly approved assay replaces the earlier Guardant360 CDx platform and transfers all seven previously approved
Biologics
FDA has accepted for review an ImmunityBio supplemental BLA seeking to expand the label for Anktiva (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guerin (BCG) for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease but without carcinoma in situ (CIS). The agency has
Drugs
An FDA review of records it requested from Hangzhou Yiqi Biotechnology Co., an active pharmaceutical ingredient manufacturer in Hangzhou, Zhejiang, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A just-released 4/15 Warning Letter says the specific deviations were: * failure to
Devices
FDA has published frequently asked questions about the TEMPO (Technology-Enabled Meaningful Patient Outcomes) pilot project, which it has launched with the Centers for Medicare and Medicaid Innovation (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. The document says the TEMPO pilot aims to: * promote access to certain
Drugs
An 11/3-11/7/2025 FDA inspection at the Harbin Jixianglong Biotech Co. active pharmaceutical ingredient (API) manufacturing facility in Harbin, Heilongjiang, China, found significant deviations from current good manufacturing practice (CGMP) regulations for APIs. A 5/1 Warning Letter says the four specific deviations were: * failure of the
Devices
The FDA breakthrough medical device program is growing, and the agency should consider additional staff and resources to keep up with oversight of medical device recalls as recommended in a 2025 Government Accountability Office report. That’s the recommendation of Stanford Law School Center for Law and the Biosciences fellow
Drugs
FDA has granted Bayer a priority review for its NDA for asundexian, an investigational oral Factor XIa inhibitor designed to reduce the risk of recurrent stroke in patients who have experienced a non-cardioembolic ischemic stroke or transient ischemic attack. The submission is based on data from the Phase 3
Drugs
The U.S. Supreme Court has declined to hear a series of pharmaceutical industry challenges to the federal government’s Medicare drug price negotiation program, preserving a key element of the Inflation Reduction Act and handing a setback to major drugmakers seeking to block the initiative. The justices, without comment,
Biologics
FDA is facing renewed scrutiny of an internal FDA analysis of pediatric deaths reported after Covid-19 vaccination, following the release of documents by Senator Ron Johnson (R-WI) that he says show federal health officials failed to fully disclose vaccine safety concerns. The controversy centers on a 12/2025
Drugs
FDA has granted Bayer a priority review for its supplemental NDA for Hyrnuo (sevabertinib) as a first-line treatment for patients with HER2-mutant non-small cell lung cancer. The filing seeks approval for sevabertinib in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose
FDA Policy/General
Rare disease advocates issued an open letter Monday urging president Trump and Congress to push FDA to accelerate approvals for treatments targeting fatal genetic disorders, arguing that regulatory delays are costing patients valuable time. The letter, signed by advocates representing families affected by Duchenne muscular dystrophy, Huntington’s disease and
Drugs
Regeneron Pharmaceuticals says its Phase 3 trial evaluating the experimental immunotherapy combination of fianlimab and cemiplimab in advanced melanoma failed to meet its primary endpoint of statistically significant improvement in progression-free survival compared with pembrolizumab (Merck’s Keytruda) monotherapy. The study tested two dose levels of the LAG-3
Drugs
Merck is reporting that its Phase 3 TroFuse-005 trial evaluating the investigational antibody-drug conjugate sacituzumab tirumotecan (Sac-TMT) met its primary endpoints of overall survival and progression-free survival in certain patients with advanced or recurrent endometrial cancer. The company says sac-TMT became the first TROP2-directed
Drugs
An FDA guidance issued last year is reshaping how pharmaceutical and medical device companies can communicate scientific information about off-label uses of approved products, while also creating new compliance challenges for industry, according to a legal analysis by Suzanne Levy Friedman (Honigman partner) posted in Life Science Leader. The
FDA Policy/General
The sudden departure of former FDA commissioner Marty Makary is unlikely to result in major changes to the agency’s approach toward direct-to-consumer (DTC) pharmaceutical advertising, according to comments from industry consultant Bob Ehrlich, CEO of DTC Perspectives. In a newsletter post distributed 5/18, Ehrlich says he
FDA Policy/General
Two prominent drug-policy scholars sharply criticized former FDA commissioner Marty Makary in a commentary published Monday, arguing that his tenure weakened the agency and undermined longstanding scientific and regulatory norms at the agency. In an article published by Health Affairs, Aaron Kesselheim and Jerry Avorn said Makary’s resignation
FDA Policy/General
FDA has replaced the acting leaders of CDER and CBER following the resignation of former commissioner Marty Makary, deepening a period of leadership instability that industry observers say could complicate regulatory decision-making for pharmaceutical companies. Tracy Beth Hoeg, who had been serving as CDER acting director, said on social
Drugs
FDA has approved AstraZeneca’s Baxfendy (baxdrostat), making it the first aldosterone synthase inhibitor in the U.S. for adults with hypertension whose blood pressure remains uncontrolled despite treatment with other medicines. The approval marks the first new mechanism for treating hypertension in roughly two decades and targets patients whose