Drugs
Two Republican senators have introduced legislation that would establish a distinct regulatory framework for homeopathic medicines at FDA, a move supporters say would preserve consumer access to alternative therapies while critics are likely to scrutinize provisions that exempt such products from traditional drug approval requirements. Senators Mike Lee (R-UT)
Drugs
Eli Lilly is reporting detailed Phase 3 results Monday showing its oral GLP-1 receptor agonist Foundayo (orforglipron) outperformed Novo Nordisk's oral semaglutide on blood sugar control and weight loss in what the company described as the first head-to-head late-stage trial comparing two oral GLP-
Drugs
FDA has placed a clinical hold on the Quantum BioPharma IND for Lucid-21-302, the company’s drug candidate to treat multiple sclerosis. According to a Quantum statement, the hold is pending submission of additional information requested by FDA. Quantum says it is reviewing FDA’s comments and will
Drugs
Eight Mintz attorneys say a recent unanimous Supreme Court decision makes clear that “skinny label” generic drug manufacturers do not induce patent infringement by simply complying with industry practice and equating the generic drug to the reference drug. In Hikma Pharmaceuticals USA v. Amarin Pharma, the court held that Amarin,
Drugs
FDA officials are seeking to bolster confidence in generic medicines, highlighting the agency's oversight of drug manufacturing, inspection programs and post-market surveillance while promoting new efforts to expand domestic pharmaceutical production. In a joint FDA Voices commentary, CDER Office of Generic Drugs director Iilun Murphy and CDER
Drugs
FDA is launching a new effort to aggregate clinical trial data on kidney safety biomarkers, seeking pharmaceutical industry participation in a pilot program that could ultimately broaden the agency's use of novel a "biomarker incubator," a regulatory science initiative designed to collect and analyze biomarker data
Drugs
FDA has approved an expanded indication for Pfizer's hemophilia treatment Hympavzi (marstacimab-hncq), allowing its use in additional patient populations that have historically faced limited treatment options, according to the company. The approval extends use of the once-weekly injectable therapy to patients aged 12 years and older
Drugs
FDA has issued a draft guidance outlining post-approval responsibilities facing manufacturers of generic drugs, highlighting requirements ranging from adverse event reporting and drug shortage notifications to labeling updates, promotional material submissions and compliance with Risk Evaluation and Mitigation Strategies (REMS). A major portion of the guidance focuses on pharmacovigilance
Drugs
FDA has issued Xspray Pharma a complete response letter for the company's NDA for Nilopki, an improved formulation of nilotinib designed to compete with Novartis' chronic myeloid leukemia (CML) therapy Tasigna. FDA told the company that it is unable to approve the application in its current form,
Drugs
With radiopharmaceutical therapies projected to expand greatly, some manufacturers are raising issues about inconsistent FDA actions through the Radiopharmaceutical Manufacturers and Therapeutic Alliance (RMTA), a trade group that evolved this year from the Medical Imaging Technology Alliance’s PET Working Group. An online AuntMinnie.com post says uneven FDA inspections
Drugs
The U.S. Supreme Court has ruled in favor of Hikma Pharmaceuticals in a closely watched patent dispute involving a generic version of Amarin Pharma's blockbuster cardiovascular drug Vascepa, finding that Amarin failed to adequately plead a claim of patent infringement through active inducement. In a decision reversing
Drugs
A Friends of Cancer Research white paper makes the case for improving FDA’s Biomarker Qualification Program (BQP) and suggests three ways the program could be strengthened. “More than a decade after its establishment,” the paper says, “the BQP has not consistently functioned as a predictable or broadly used pathway
Drugs
U.S. House lawmakers have unveiled bipartisan legislation aimed at expanding federal scrutiny of U.S. investments in China's biotechnology sector, arguing that American capital and expertise are accelerating the growth of a strategic industry that could undermine U.S. economic and national security interests. Reps. John Moolenaar
FDA Policy/General
Former Oncology Center of Excellence and short-time CDER director Richard Pazdur says it’s time to restructure the agency’s organization into various new Centers. As reported by MedCity News, Pazdur appeared on a STAT panel during but apart from the recent annual meeting of the American Society of
Drugs
In an effort to win back a constituency that has become disenchanted with FDA, acting commissioner Kyle Diamantas met on 6/3 with representatives from several advocacy groups that support people with rare diseases. Reuters reports that although Diamantas heads the agency’s food program and lacks the background traditionally
Drugs
A Senate Special Committee on Aging 6/3 hearing took testimony that older Americans are at risk of death by poisoning due to faulty drug supply chains. A Legis1 online report says an earlier committee hearing looked at foreign generic drug quality and drug labeling transparency. “Witnesses brought personal and
Drugs
FDA says a 3/17-3/21/2025 Bioresearch Monitoring Program inspection at HealthPartners Neuroscience Center Research and Innovation in St. Paul, MN, determined that the facility did not adhere to the applicable statutory requirements and applicable regulations governing the conduct of nonclinical laboratory studies. A 5/19 Warning Letter
Drugs
Two Morgan Lewis attorneys say that while a new FDA draft guidance on three-year new clinical investigation exclusivity “does not break much new ground, it nonetheless serves as a helpful resource for applicants of NDAs seeking the exclusivity as well as applicants of follow-on applications potentially impacted by
Drugs
FDA says CDER has accepted the first letter of intent for an in silico drug development tool (DDT) into the Innovative Science and Technology Approaches for New Drugs (ISTAND) DDT qualification program. Accepting the letter of intent is the first of three steps the DDT must pass to be qualified
Drugs
FDA has accepted for priority review a Roche NDA for giredestrant, an investigational oral endocrine therapy that could become the first selective estrogen receptor degrader (SERD) approved for use in patients with early-stage estrogen receptor-positive breast cancer. The filing seeks approval of giredestrant as an adjuvant treatment for
Drugs
FDA has issued Cingulate a complete response letter (CRL) on the company's NDA for CTx-1301, an investigational treatment for attention-deficit/hyperactivity disorder. The agency’s concerns were limited to requests for additional chemistry, manufacturing and controls (CMC) information, according to the company, noting that the letter
Drugs
A 10/6-10/14/2025 FDA inspection at the Medline drug manufacturing facility in Waukegan, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs that were similar to violations found previously in other company units. A 5/28 Warning Letter says the two violations