Drugs
FDA says Sandoz recalled one lot of Cefazolin for Injection, USP, 1 gram vial, following a customer complaint indicating that four penicillin G potassium for injection, USP, 20 million units labeled vials were incorrectly included in a carton of Cefazolin for Injection. An agency notice says there is a reasonable
Drugs
FDA has published a draft guidance, Myelodysplastic Syndromes: Development of Drug and Biological Products for Treatment, to assist sponsors in the clinical development of products to treat the syndromes. The document contains the agency’s current thinking about the overall development program and clinical trial designs for the development of
Drugs
A 6/3-6/11/2024 FDA bioresearch monitoring inspection at a clinical site maintained by Dr. Peter Michael in Hialeah, FL, found that Michael did not adhere to the law and regulations governing the conduct of clinical investigations and protecting human subjects in two studies. A just-released 6/
Drugs
FDA has given accelerated approval to Regeneron’s Lynozyfic (linvoseltamab-gcpt), a bispecific B-cell maturation antigen-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-
Drugs
A 12/13-12/20/2024 FDA inspection at the Healwell Homeo Private Limited drug manufacturing facility in Ahmedabad, Gujarat, India, found the firm’s homeopathic and over-the-counter drug products were adulterated in that they were prepared, packed, or held under insanitary conditions so they may have become
Drugs
FDA says its review of a Web site maintained by www.buynetmeds.com determined that it is selling misbranded and unapproved new drugs. A just-released 6/12 Warning Letter says the agency observed that the site introduces into interstate commerce unapproved and misbranded opioid drug products. The letter also
Drugs
FDA says it is revising the labeling of all extended-release stimulants intended to treat attention-deficit/hyperactivity disorder (ADHD), including certain formulations of amphetamine and methylphenidate, to warn about the risk of weight loss and other adverse reactions in patients younger than age six taking the medications. An agency
Drugs
FDA has issued a draft guidance entitled Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations. The document is intended to clarify key factors in calculating the aluminum content to ensure that the total aluminum exposure (TAE) from parenteral nutrition (PN) does
Drugs
A new FDA report breaks down the demographic representation of clinical trials supporting the approval of 50 novel drug therapies approved in 2024, which involved 31,000 clinical trial participants. The report, which is intended to provide insight into persistent disparities and areas of progress in clinical research, is part
Drugs
In a move to reduce burdens on healthcare providers and improve patient access, FDA is removing risk evaluation and mitigation strategies (REMS) requirements for all currently approved BCMA- and CD19-directed autologous CAR T cell therapies, explaining that the programs are no longer necessary to ensure patient safety. The action
Drugs
UCB is announcing positive data from a Phase 3 clinical trial evaluating fenfluramine as an adjunctive treatment for CDKL5 Deficiency Disorder (CDD). The trial met both its primary and key secondary endpoints in patients with the rare and severe form of epilepsy, according to the company. The primary outcome was
Drugs
The U.S. Court of Appeals for the D.C. Circuit has upheld a lower court’s decision for FDA that a “clinically superior drug is not the same as a drug that is otherwise the same.” The appeals court reaffirmed that FDA acted correctly in determining that Avadel CNS
Drugs
Achieve Life Sciences has submitted an NDA for cytisinicline for treating nicotine dependence as part of smoking cessation in adults. The submission is based on data from two placebo-controlled Phase 3 trials, ORCA-2 and ORCA-3. “In both studies, cytisinicline administered for either six or 12 weeks, alongside
Drugs
FDA has issued safety-related labeling updates for two bile acid transport inhibitors — Mirum Pharmaceuticals’ Livmarli (maralixibat) and Ipsen Biopharmaceuticals’ Bylvay (odevixibat) — to emphasize increased risks of liver injury and bleeding associated with their use. The changes are based on new data from expanded clinical trials and postmarketing experience, an
Drugs
FDA has published a guidance, Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial Diseases—Questions and Answers, to help sponsors in the clinical development of new antibacterial drugs to treat serious bacterial diseases, particularly those caused by antimicrobial drug-resistant organisms, in patients
Drugs
Altimmune is announcing mixed topline results today from its Phase 2b IMPACT trial evaluating pemvidutide in patients with metabolic dysfunction-associated steatohepatitis (MASH), a progressive liver disease. The study showed that pemvidutide led to significant improvements in disease resolution and weight loss, with promising signals of anti-fibrotic activity, according
Drugs
FDA has published a guidance, Conducting Remote Regulatory Assessments—Questions and Answers, to help enhance the industry’s understanding of such assessments, thus facilitating the process for FDA conducting the assessments. The document says the term Remote Regulatory Assessment (RRA) is used to describe a category of activities for which
Drugs
FDA has granted regenerative medicine advanced therapy designation for enGene Holdings’ detalimogene voraplasmid, the company’s lead investigational therapy to treat high-risk, Bacillus Calmette-Guérin-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ. A company statement describes detalimogene as a novel non-viral gene-based immunotherapy for
Drugs
Viatris says it will submit an NDA later this year for its MR-141 (phentolamine ophthalmic solution 0.75%) for treating presbyopia based on just-released data from the Phase 3 VEGA-3 trial. Presbyopia is a progressive vision condition affecting older adults that reduces their ability to focus on
Drugs
A 3/4-3/6 FDA inspection at the Sterling Distributors wholesale distribution facility in Coral Springs, FL, found significant violations of Drug Supply Chain Security Act (DSCSA) requirements. A 6/5 Warning Letter says the specific violations were: * engaging in wholesale distribution of prescription drugs without being appropriately licensed;
Drugs
FDA has released a final guidance entitled “Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment.” The document provides FDA’s current recommendations regarding the development of drugs to support an indication for the treatment of early Lyme disease as manifested by erythema migrans (EM). The guidance
Drugs
FDA has approved an updated label for Eli Lilly’s Amyvid (florbetapir F 18 injection) for brain imaging to estimate amyloid plaque density in patients with cognitive impairment being evaluated for Alzheimer’s disease and other causes of cognitive decline. The label update includes: * Revising how Amyvid can be used