Drugs
FDA has approved Priovant Therapeutics’ Lisraya (brepocitinib) tablets for treating dermatomyositis in adults. “For too long, patients with dermatomyositis have faced a significant unmet need for effective treatments, often relying on therapies meant for other diseases,” FDA says in a release. “Dermatomyositis is a rare autoimmune disease in which the
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
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
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
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
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
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
Drugs
Washington State University College of Pharmacy and Pharmaceutical Sciences affiliate professor Sarfaraz Niazi is petitioning FDA to extend the product-level, evidence-scaled logic reflected in its therapeutic-equivalence and biosimilar programs into a unified reference-anchored framework for follow-on human drugs and biological products. The petition says the
Biologics
An 11/17-12/16/2025 FDA inspection at the R3 Medical Companies’ Bello Bio and Regen Suppliers units in Scottsdale, AZ, documented that Bello contract manufactures and labels several umbilical cord-derived products and Regen approves, labels, stores, and distributes the Bello products and an umbilical cord product contract
Drugs
Friends of Cancer Research says it recently published two manuscripts supporting the use of circulating tumor DNA (ctDNA) as an early endpoint for regulatory decision-making. In a media release (contains links to the articles), the advocacy group says the manuscripts “show that on-treatment reductions in ctDNA levels are
Drugs
The Sedgwick Recall Index covering the first half of 2026 shows that the number of medical device recalls fell from 487 to 462 (down 5.1%), while the number of units recalled increased 516.8% from 50.7 million units in the first half of 2025 to 313.07 million
Drugs
Florence Healthcare says the FDA Expedited IND Pilot Program, part of the government’s Operation TrialBlazer, “takes the right premise seriously: that the United States cannot regulate its way past a site infrastructure problem.” In its response to the agency’s Request for Information, Florence’s comments relate to: * the
Drugs
As Amgen continues its bid to prevent the withdrawal of Tavneos (avacopan) in the U.S., a new study using a U.S. rheumatology registry has found that while liver enzyme elevations were uncommon among patients treated with avacopan, it identified two cases of drug-induced liver injury (DILI), including
Drugs
House Select Committee on China chairman John Moolenaar (R-MI) and Rep. Ben Cline (R-VA) are urging FDA intensify safeguards on clinical trial data generated in China, citing concerns about transparency and potential underreporting of serious adverse events and patient deaths. In an 8/20 letter to acting FDA
Drugs
Scholar Rock said Friday that it has made further regulatory progress for apitegromab, its investigational treatment for spinal muscular atrophy (SMA), removing a troubled Catalent (part of Novo Nordisk) facility from its BLA resubmission. The facility removal was recommended by FDA after Scholar added a second U.S.-based fill-