Drugs
FDA has accepted for review a Grace Therapeutics NDA for GTx-104 (nimodipine for injection) for treating patients with aneurysmal subarachnoid hemorrhage (ASH). The company says the submission was supported by a comprehensive data package including positive data obtained from the company’s Phase 3 STRIVE-ON safety trial of
Biologics
FDA has approved supplemental BLAs from Moderna and Pfizer/BioNTech for their mRNA Covid-19 vaccines with 2025-2026 formulations that target the LP.8.1 variant of SARS-CoV-2, which is the dominant circulating strain of the disease. The agency also approved Novavax’s Nuvaxovid Covid vaccine for
Drugs
Regeneron Pharmaceuticals says it will seek FDA approval early next year for its investigational RNA-based therapy cemdisiran after announcing results from the Phase 3 NIMBLE trial where all primary and key secondary endpoints were met for treating generalized myasthenia gravis. Cemdisiran is described by the company as an siRNA
Drugs
Eli Lilly says it will soon seek FDA approval for its investigational obesity pill orforglipron following its 8/26 release of “positive topline results” from the Phase 3 ATTAIN-2 trial that evaluated the oral GLP-1 receptor agonist in obese or overweight adults with Type 2 diabetes. “In the
Devices
A 3/4-4/16 FDA inspection at the LeMaitre Vascular facility in North Brunswick, NJ, found Quality System Regulation violations in the firm’s manufacturing of Artegraft Collagen Vascular Grafts. An 8/11 Warning Letter says the specific Quality System violations were: * failure to establish and maintain procedures to
Drugs
FDA has granted fast-track designation to Allarity Therapeutics’ stenoparib, an investigational treatment for patients with advanced ovarian cancer. A company statement describes stenoparib as an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. The company says it recently began patient enrollment under a
Biologics
FDA has extended by three months its review of an Axogen BLA for Avance Nerve Graft after the agency determined that information submitted by the company in response to an agency request was deemed a major amendment. The information submitted included substantial new manufacturing and facility data not previously reviewed
Devices
A 3/31-4/23 FDA inspection at the Miach Orthopaedics facility in Westborough, MA, identified 11 Quality System and Medical Device Reporting regulation violations in the firm’s manufacturing of the Bridge-Enhanced ACL Restoration implant intended to treat anterior cruciate ligament injuries. An 8/19 Warning Letter says
Drugs
The Biotechnology Innovation Organization (BIO) says its priorities for when Congress returns in September are reauthorization of the FDA Pediatric Priority Review Voucher (PPRV) program and the Small Business Innovation Research/ Small Business Technology Transfer (SBIR/STTR) seed-funding program. An online statement says patients and innovators have been relying
Drugs
A 1/15-1/24 inspection by the FDA Office of Bioresearch Monitoring Inspectorate Foreign Inspection Cadre at Jiangsu Kerbio Medical Technology Group Co. in Jiangsu Sheng, China, found serious violations of good laboratory practice for nonclinical laboratory studies regulations. A just-released 7/11 Warning Letter says the specific
Devices
FDA has granted Santersus a breakthrough device designation for its NucleoCapture blood purification system for patients with severe, treatment-resistant systemic lupus erythematosus. This is the second time the device has earned the designation, following earlier recognition for treating sepsis. NucleoCapture is described as an extracorporeal apheresis column designed to
Biologics
Inovio Pharmaceuticals says it has started a rolling BLA submission for INO-3107, an experimental DNA medicine for recurrent respiratory papillomatosis (RRP), with the goal of securing FDA approval by the end of the year. The company expects to complete the filing in the coming months and plans to request
Devices
FDA has granted Quest Diagnostics a breakthrough device designation for its Haystack MRD test, a liquid biopsy designed to detect minimal residual disease (MRD) in patients with Stage II colorectal cancer after curative surgery. Quest says it introduced a laboratory-developed version of Haystack MRD in late 2024 and has
Devices
FDA is cautioning health care providers and facilities about the safe use of hyperbaric oxygen therapy (HBOT) devices following reports of serious injuries and deaths tied to their use. In a recent safety communication, the agency urges providers to strictly follow manufacturers’ instructions and to reinforce fire prevention measures when
Drugs
FDA has expanded the approved use of Amgen’s cholesterol-lowering drug Repatha (evolocumab) to include adults at increased risk of major adverse cardiovascular events due to uncontrolled low-density lipoprotein cholesterol (LDL-C), even if they have not been diagnosed with cardiovascular disease. The change removes a key limitation
Biologics
Argenx says it will file a supplemental BLA for Vyvgart (efgartigimod alfa-fcab) to expand its label to include adults with acetylcholine receptor antibody (AChR-Ab) seronegative generalized myasthenia gravis (gMG) after reporting positive topline results from a Phase 3 trial of patients in this patient population. The company says
Drugs
CBER has suspended Valneva Austria’s BLA for Ixchiq (chikungunya vaccine, live) due to serious safety concerns related to the vaccine, which appears to be causing chikungunya-like illness in vaccine recipients. The vaccine was granted accelerated approval in 2023 for the preventing disease caused by the chikungunya virus (CHIKV)
FDA Policy/General
An FDA-conducted clinical trial has found that daily use of cannabidiol (CBD) at levels similar to those reported by consumers can cause elevated liver enzymes in otherwise healthy adults, raising fresh safety questions about the popular products. The study by CDER scientists is the first randomized, placebo-controlled trial
Biologics
FDA has accepted for priority review a Gamida Cell supplemental BLA for omidubicel and its use in severe aplastic anemia, a rare and often life-threatening condition in which the bone marrow fails to produce sufficient blood cells. Hematopoietic stem cell transplants can be curative, but many patients lack a
Drugs
Vanda Pharmaceuticals has requested FDA commissioner Marty Makary to reconsider a recent agency decision upholding approvals of two generic versions of Hetlioz (tasimelteon), the company’s drug for non-24-hour sleep-wake disorder. The request follows a July ruling by recently retired CDER director Jacqueline Corrigan-Curay, who sided
Devices
AdvaMed and other device stakeholders are urging the Centers for Medicare & Medicaid Services (CMS) to overhaul how it covers new device technologies, warning that patients are waiting years too long for access to innovations approved and cleared by FDA. In a recent letter to CMS administrator Mehmet Oz, the
Drugs
Boston Scientific is recalling (Class 1) its Carotid Wallstent Monorail Endoprosthesis due to a manufacturing defect that created an inner lumen smaller than specifications, which causes resistance when withdrawing the stent delivery system. “Using the affected stent systems could cause serious harm, such as injury to the blood vessel, damage