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 assist 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
FDA has approved a PTC Therapeutics NDA for Sephience (sepiapterin), indicated for treating adult and pediatric patients with phenylketonuria (PKU), a rare inherited metabolic disorder. “The approval includes broad labeling for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients one month of age and older with sepiapterin-responsive
FDA Policy/General
FDA has posted the following user fee rates for fiscal year 2026 (effective 10/1). They are: * Prescription drugs and biologics: $4.682 million for an application requiring clinical data. This is an 8.6% increase in the current fee. The annual program fee is $442,213, which is a
Drugs
Recognify Life Sciences says its Phase 2b trial of inidascamine, a drug candidate for treating cognitive impairment associated with schizophrenia (CIAS), did not meet its primary efficacy endpoint, though it did show encouraging signals of cognitive benefit and reaffirmed the drug's strong safety profile. The six-week, placebo-
Drugs
Under mounting criticism of FDA commissioner Marty Makary bypassing the agency’s advisory committee processes to address health issues under an “expert panel” process, the agency 7/28 announced an open docket to collect public input on a 7/17 panel that addressed warnings associated with hormone replacement therapies (HRT)
Drugs
FDA has issued a revised draft guidance entitled Small Volume Parenteral (SVP) Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations. The document reiterates the agency’s position on the importance of minimizing aluminum contamination and provides the rationale for setting an aluminum limit for
Biologics
FDA is investigating another death of a young boy who received Sarepta Therapeutics’ gene therapy Elevidys for Duchenne muscular dystrophy. The death of the eight-year-old occurred on 6/7. The company recently complied with an FDA request to suspend the product’s distribution as it investigates ongoing safety
Drugs
Roche is reporting new data on its Alzheimer’s therapy trontinemab and its plans to begin two Phase 3 clinical trials by the end of the year. Trontinemab, delivered via Roche’s proprietary Brainshuttle technology, continues to show promising results in an ongoing Phase 1b/2a study, according to the
FDA Policy/General
U.S. Representative Richard Hudson (R-NC) is leading a group of bipartisan House lawmakers in sending a letter to FDA commissioner Marty Makary urging the agency to take immediate action against the rising threat of illegal, counterfeit anti-obesity medications entering the U.S. The counterfeit products, which include
Biologics
FDA is backpedaling its enforcement stance against Sarepta Therapeutics and Duchenne muscular dystrophy (DMD)gene therapy Elevidys after determining the latest death (see story) reported after a patient was administered the product was unrelated. “The U.S. Food and Drug Administration is recommending the removal of the voluntary hold for
Devices
FDA has cleared a Stereotaxis 510(k) for its MAGiC Sweep catheter, which it describes as the world’s first robotically navigated high-density electrophysiology (EP) mapping catheter for diagnosing and treating complex arrhythmia patients. “High density mapping has transformed the EP field, enhancing cardiac ablation procedures by enabling more
FDA Policy/General
FDA commissioner Marty Makary has defended CBER director Vinay Prasad from an online attack by far-right influencer and Trump confidant Laura Loomer in which she called for his removal for being too left-wing. In an interview with Politico, Makary said Prasad does not have a “political bone” in
Drugs
FDA has extended by three months its review of a Bayer NDA for elinzanetant, a neurokinin 1 and neurokinin 3 receptor antagonist for treating moderate to severe vasomotor symptoms (hot flashes) due to menopause. The agency told the company that additional time is needed for a full review of the
Drugs
FDA and American Society of Clinical Oncology (ASCO) researchers are urging drug makers to abandon outdated drug dosing strategies that are potentially putting cancer patients at risk. Their just-posted article in the Journal of Clinical Oncology lays out a new scientific framework aimed at ensuring patients receive cancer treatments
Drugs
Edwards Lifesciences has recalled (Class 1) its OptiSite Arterial Perfusion Cannula and Peripheral Femoral Arterial Cannula after receiving reports in which a 3mm to 4mm section of wire, from the wire-reinforcement coil at the cannula tip, was found to be exposed (released from the cannula body). “Since some Femoral
Drugs
FDA has issued an alert based on its ongoing investigation into the root causes of benzene contamination, calling on drug makers to evaluate their manufacturing processes, particularly where ingredients derived from hydrocarbons are used. The agency identified several components of concern, including carbomers (thickening agents), isobutane (a spray propellant), and
Devices
Ethicon Endo-Surgery is recalling (Class 1 device correction) its Echelon Flex Powered Vascular Stapler to correct the product’s inadvertent lockout during surgical procedures. The device will momentarily activate but will not cut or staple tissue, a recall notice says. “Additional steps will be required to open it and
Devices
Medline Industries is recalling (Class 1 device correction) certain lots of its Craniotomy Kits containing recalled Codman Disposable Perforators 14mm. Integra LifeSciences has recalled the perforators due to an inadequate weld that may cause the perforator to come apart before, during or after use in a craniotomy procedure, a recall
Drugs
FDA will give priority review to Sprout Pharmaceuticals’ sNDA for an expanded indication for its Addyi (flibanserin) to treat low sexual desire in post-menopausal women. A company statement says Addyi is currently the only FDA-approved pill to treat low sexual desire in women. Sprout says Addyi works on
Biologics
FDA reportedly will require additional safety data from Sarepta Therapeutics before the agency considers supporting the continued use of the company’s Duchenne muscular dystrophy (DMD) gene therapy Elevidys (delandistrogene moxeparvovec-rokl) following three recent patient deaths — two associated with Elevidys and the other associated with an experimental gene therapy
Drugs
Abivax is announcing favorable topline results from two pivotal Phase 3 induction trials of its investigational oral therapy obefazimod (ABX464) in moderately to severely active ulcerative colitis (UC) patients. Both trials met their primary endpoint, demonstrating statistically significant rates of clinical remission at eight weeks with the once-daily 50
FDA Policy/General
Rep. Nikema Williams (D-GA) and three other legislators have introduced the Plain Prescription Prices Act that would require direct-to-consumer TV ads for prescription drugs to include a statement of the drug’s list price. In a statement, Williams says the legislation “will empower consumers to hold drug