Drugs
FDA’s approval of new drugs is increasingly being supported by fewer clinical studies, while industry-sponsored research represents a much larger share of the evidence behind those approvals, according to a new analysis published in PLOS One. Researchers from Stanford University, Oregon State University, UCLA and other institutions looked
FDA Policy/General
FDA has cited Alar Pharmaceuticals over promotional materials for its investigational ketamine drug, ALA-3000, because they improperly portrayed the unapproved drug as safe and effective for treatment-resistant depression. A just-posted 8/21 untitled letter from CDER Office of Prescription Drug Promotion (OPDP) says the materials were on
Biologics
FDA has approved updated Covid-19 vaccines from Moderna, Pfizer-BioNTech and Novavax/Sanofi for the upcoming vaccination season. The vaccines are formulated to better match the XFG variant currently in circulation. The updated vaccines include Moderna's Spikevax and mNEXSPIKE, Pfizer-BioNTech's Comirnaty and Novavax-Sanofi&
Drugs
FDA has approved Eli Lilly’s Mounjaro (tirzepatide) for lowering the risk of major adverse cardiovascular (CV) events (MACE), including CV death, non-fatal heart attack, or non-fatal stroke in adults with Type 2 diabetes who are at high risk for such events. The dual GIP and GLP-1
Devices
FDA has issued an Early Alert after becoming aware that Boston Scientific sent a letter to customers recommending all Imager II Angiographic Catheters be removed from where they are used or sold because of a manufacturing issue affecting the catheter tip. The devices are used to create images of specific
Drugs
A new report from Senate HELP chair Bill Cassidy (R-LA) is criticizing FDA for allowing the abortion drug mifepristone’s Risk Evaluation and Mitigation Strategy (REMS) to remain in place without requiring sponsors to conduct meaningful oversight of prescribing patterns. The report, released following a committee investigation, examined the
FDA Policy/General
FDA’s intensified scrutiny of drug advertising is extending beyond direct-to-consumer (DTC) television and radio spots, with lawyers alerting companies to prepare for closer examination of promotional claims, supporting data, social-media content and the use of artificial intelligence. The agency’s is approaching the one-year anniversary
Devices
A MasterControl analysis of the first months of medical device inspections under the new FDA Quality Management System Regulation (QMSR) found that agency investigators are “uncovering interconnected problems that span a company’s entire quality system.” A MasterControl statement says the investigators are increasingly finding that complaint-handling deficiencies, corrective
Drugs
Three Akin Gump attorneys say the PDUFA 8 commitment letter released by FDA earlier this month details performance goals and procedures across six areas of focus: (1) ensuring the effectiveness of the human drug review program; (2) continued enhancement of user fee resource management; (3) transparency in FDA hiring and
Drugs
So far, every court that has been presented with a Loper Bright argument against preemption in a product liability case has rejected it, according to attorney James Beck (Reed Smith). Writing in a Drug & Device Law online post, Beck says the courts have recognized that Loper Bright (1) only
Drugs
The U.S. Court of Appeals for the Fifth Circuit has upheld FDA’s decision to remove tirzepatide from the agency’s drug shortage list, a ruling that limits the ability of pharmacies and compounding facilities to produce versions of the popular drugs. The case involved Eli Lilly’s Mounjaro
Drugs
The Biotechnology Innovation Organization (BIO) says it agrees with FDA that it is critical to shorten the time it takes from drug identification to first-in-human study. In a comment letter, BIO says the agency’s proposed pilot for an expedited Investigational New Drug (IND) “presents a timely opportunity
Drugs
Rep. Lauren Boebert (R-CO) has introduced the Advancing Botanical Drug Development Act of 2026, which she says would expand treatment options for chronic, complex and age-related diseases while maintaining existing FDA safety and efficacy requirements. In a statement, Boebert says her legislation “would address the barriers to late-
Drugs
FDA has approved Revolution Medicines’ Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer — providing a new treatment option to patients with advanced pancreatic cancer 6.5 months ahead of the user fee review action target date. The once-a-day tablet “targets multiple forms of
Drugs
Celcuity has submitted a supplemental NDA for Revtorpyk (gedatolisib) for treating patients with hormone receptor positive, human epidermal growth factor receptor 2 negative (HER2-), locally advanced or metastatic breast cancer (ABC) with a PIK3CA mutation, following progression on or after treatment with at least one line of endocrine therapy. Last
Drugs
One of the key takeaways from a 4/23 meeting convened by FDA and the Duke Margolis Institute for Health Policy to discuss increasing access to nonprescription drugs was the recognition that additional efforts may be necessary to capture information on nonprescription drug use in electronic health records or via
Devices
FDA says the Boston Scientific 7/9 recall of its ENROUTE Transcarotid Neuroprotection System is Class 1. An agency notice says the company notified customers that the affected devices should be removed from where they are used or sold. The ENROUTE Transcarotid System reportedly is designed to transport emboli away
FDA Policy/General
HHS is planning to name an FDA deputy commissioner for technology and a deputy commissioner for drugs, according to a CNBC report. The network says some anonymous sources in the Trump administration see the new appointments as a way to exert greater influence over the agency. Both of the new
Drugs
Two physicians affiliated with Stanford University’s medical school are urging FDA to approve carbetocin for preventing postpartum hemorrhage, arguing that the drug could provide a longer-lasting alternative to currently available uterotonic medications. In an 8/25 citizen petition, Kenneth Nguyen and Pervez Sultan asked FDA to approve carbetocin
Devices
CDRH is issuing an early alert to notify the public about an Abiomed action recommending that all Automated Impella Controllers (AIC) be removed from where they are used or sold. The removal is due to “purge cassette recognition issues resulting from failures of the purge flag component within the purge
Drugs
The American Society of Clinical Oncology/Association for Clinical Oncology (ASCO) says its members have reported critical supply disruptions of ifosfamide, leaving some practices with less than a few weeks of inventory. An ASCO statement says that with no direct substitute for this essential chemotherapy agent, practices are urged to
Devices
FDA has granted Abbott Diabetes Care a de novo authorization for the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged two years and older living with diabetes. The agency says the device is the first wearable in the U.S. to continuously monitor both ketones