Drugs
FDA has approved a Boehringer Ingelheim NDA for Jascayd (nerandomilast) tablets for treating idiopathic pulmonary fibrosis (IPF). The oral phosphodiesterase 4B (PDE4B) inhibitor was approved based on results from two randomized, double-blind, placebo-controlled trials showing that Jascayd significantly slowed lung function decline compared with placebo, according to an
Drugs
In a Food & Drug Law Institute review of Warning Letters (WLs) issued by FDA since 1/9/2020, a Hyman, Phelps & McNamara attorney and a regulatory expert say Tuesdays are the most common day for a WL to appear on the FDA Web site. The analysis found that
Drugs
A 3/19-3/25 FDA inspection at the Creative Essences drug manufacturing facility in Santa Fe Springs, CA, found multiple violations, including significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/25 Warning Letter says the specific violations were: * failure to thoroughly investigate any
Drugs
Six months after being forced to resign, former CBER director Peter Marks has landed at Lilly Research Laboratories to oversee molecule discovery and infectious disease programs, according to news reports. Marks’ forced resignation in early April marked the beginning of an upheaval at the Center that saw numerous staff leave
Drugs
FDA has lifted a clinical hold on Neurizon Therapeutics on its lead experimental treatment for amyotrophic lateral sclerosis (ALS), clearing the way for Phase 2/3 development of NUZ-001 as part of the HEALEY ALS Platform Trial, which is expected to begin later this quarter. “Supported by our compelling
Drugs
FDA has accepted for priority review an Orca Bio BLA for Orca-T, an investigational allogeneic T-cell immunotherapy for patients with acute myeloid leukemia, acute lymphoblastic leukemia, and myelodysplastic syndromes. The agency has set 4/6/2026 as the user fee review action target date. If approved, Orca-T
Drugs
FDA has issued Dr. Reddy's Laboratories a five-item Form FDA-483 after inspecting the firm’s drug substance and drug product manufacturing facility last month in Telangana, India. According to the FDA-483, the agency cited the following: * The quality unit has not established adequate procedural controls
Drugs
AstraZeneca and Daiichi Sankyo say new data show that their antibody-drug conjugate Datroway (datopotamab deruxtecan) significantly improved survival outcomes for patients with metastatic triple-negative breast cancer who are not eligible for immunotherapy. Results from the Phase 3 TROPION-Breast02 trial also showed the therapy met its second co-
Drugs
Abivax is announcing new Phase 3 data showing that its lead drug candidate, obefazimod, achieved clinically meaningful improvements across all efficacy endpoints in patients with moderately to severely active ulcerative colitis — including those who had previously failed multiple advanced therapies. The results, presented at the United European Gastroenterology Meeting in
Drugs
FDA has approved an Arcutis Biotherapeutics supplemental NDA for Zoryve (roflumilast) cream 0.05% for treating mild to moderate atopic dermatitis in children ages 2 to 5, expanding access to the company’s once-daily, steroid-free topical therapy. “In clinical trials, Zoryve cream 0.05% rapidly improved eczema severity,
Drugs
FDA has unveiled a new pilot program to prioritize the review of certain generic drug ANDAs in an effort to boost domestic pharmaceutical manufacturing and testing. The initiative will give faster review timelines to generic drugmakers that conduct bioequivalence testing in the United States and manufacture products domestically using U.
Drugs
FDA commissioner Marty Makary says he wants to speed up the nation’s drug approval process without compromising safety, describing his plans to “modernize” the agency in a wide-ranging interview with CNN’s Sanjay Gupta. Speaking in Atlanta last week during a CEO listening tour, Makary told Gupta that
Drugs
A new Brookings Institution commentary is raising concerns about FDA’s new Commissioner’s National Priority Voucher (CNPV) pilot program, arguing that its core incentive of accelerated drug reviews may fall short of advancing broader public health goals like onshoring drug production and improving affordability. Launched in June, the CNPV
Drugs
FDA is facing mixed reactions after approving the second generic copy of the abortifacient drug mifepristone 10/2. The manufacturer, Evita Solutions, becomes the second company authorized to market a generic version of the drug, joining GenBioPro, whose generic version was approved in 2019. The approval comes at a time
Drugs
Amgen says the landmark Phase 3 VESALIUS-CV trial met its primary endpoints, demonstrating that Repatha (evolocumab) significantly reduced the risk of major adverse cardiovascular events in individuals without a prior history of heart attack or stroke. A company statement says the study involved over 12,000 high-risk patients.
Drugs
FDA has released a four-item Form FDA 483 that was issued to Laboratorios Grifols after a 7/2024 inspection of the firm’s drug manufacturing facility in Barcelona, Spain. For example, the agency cited the firm for failing to establish written procedures for production and process controls, and for
Drugs
FDA has approved Jazz Pharmaceuticals’ Zepzelca (lurbinectedin) in combination with atezolizumab (Genentech’s Tecentriq) or atezolizumab and hyaluronidase-tqjs (Genentech’s Tecentriq Hybreza) for the maintenance treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). The approval covers patients whose disease has not progressed following initial treatment
Drugs
FDA commissioner Martin Makary says changes easing the Boxed Warning on hormone replacement therapies should be announced soon. “We are in serious discussion now about what to do about the black box warning, and I think you’ll hear something on it very soon,” Makary said on a CNN podcast.
Drugs
FDA has granted Bristol Myers Squibb fast-track status for its investigational Alzheimer’s therapy BMS-986446. The anti-microtubule binding region tau (anti-MTBR-tau) antibody is currently in Phase 2 testing for patients with early disease. The company says BMS-986446 is designed to target fragments of tau
Drugs
FDA has issued a report, “An Assessment in Support of the Sentinel System (2022 to 2024),” highlighting the Sentinel System’s activities and achievements in the study period. The report fulfills one of the commitments in the Prescription Drug User Fee Act VII reauthorization letter to maintain Sentinel initiative capabilities
Drugs
FDA and Vanda Pharmaceuticals have agreed to a framework for resolving their ongoing disputes about the company’s sleep-wake cycle drug Hetlioz (tasimelteon) and its gastroparesis drug tradipitant. A Vanda statement lists these features of the agreement: * FDA will conduct an expedited re-review of the partial clinical hold
Drugs
FDA has issued 17 new and 64 revised product-specific guidances (PSGs) with recommendations for developing generic drugs and generating evidence to support ANDA approvals. The PSGs contain: * 48 PSGs for products with no approved ANDAs, including 25 complex products; * 39 PSGs for complex products (six new and 33 revised