Drugs
FDA has approved an expanded indication for Teva and Medincell’s Uzedy (risperidone) to permit its use as monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of adults with Bipolar I disorder. The once-monthly extended-release injectable suspension for subcutaneous use was first approved in
Drugs
Tvardi Therapeutics is reporting that its experimental drug TTI-101 failed to show benefit in a Phase 2 clinical trial for idiopathic pulmonary fibrosis, a progressive and fatal lung disease. The company said the trial did not meet its endpoints and variability in the data limited interpretation of the results.
Drugs
FDA has extended by three months its review of a Denali Therapeutics BLA for tividenofusp alfa, a potential treatment for mucopolysaccharidosis Type II (MPS II), also known as Hunter syndrome. According to the company, the review action target date has been pushed back — from 1/5/2026 to 4/5
Drugs
FDA has approved an expanded indication for Medtronic’s Endurant II/IIs Stent Graft System, allowing its use in abdominal aortic aneurysm (AAA) patients with short, challenging neck anatomies when used with the company’s Heli-FX EndoAnchor System. The approval enables treatment of patients with aortic neck lengths as
Drugs
FDA has granted BeOne Medicines a breakthrough therapy designation for sonrotoclax and its use in treating adults with relapsed or refractory mantle cell lymphoma (MCL). The designation is based on positive data from a Phase 1-2 clinical study (BGB-11417-201) evaluating sonrotoclax in patients with MCL who had
Drugs
FDA has given an “Official Action Indicated (OAI)” classification to a recent inspection of a Novo Nordisk manufacturing facility in Bloomington, IN. The July inspection revealed significant GMP deficiencies. The serious compliance designation could delay the approval and production timelines for drug products, including those from partner companies, including Regeneron
Drugs
FDA has approved an updated indication for AbbVie’s Rinvoq (upadacitinib), expanding its use in treating adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). The label update allows physicians to prescribe Rinvoq prior to tumor necrosis factor (TNF) blocker therapy for patients who have
Drugs
FDA has approved new labeling for Janssen Biotech’s Carvykti (ciltacabtagene autoleucel, including a Boxed Warning highlighting the risk of immune effector cell-associated enterocolitis (IEC-EC), a potentially life-threatening gastrointestinal complication. The warning comes after the agency reviewed reports from clinical trials and postmarketing data documenting cases of
Drugs
FDA has granted Precision NeuroMed an orphan drug designation for IL13-PE38QQR (cintredekin besudotox), an investigational therapy targeting glioblastoma multiforme, an aggressive and often lethal form of brain cancer. The cytotoxic protein is engineered to attack cells expressing the IL-13 alpha-2 receptor — a marker commonly found on glioblastoma
Drugs
FDA says it is monitoring reports of contaminated children’s cough and cold medicines manufactured in India but confirmed that the affected products have not been shipped to the U.S. An agency notice says it is aware of an ongoing investigation in India into cough syrups contaminated with diethylene
Drugs
FDA has granted Adcendo a fast track designation for ADCE-D01, an investigational antibody-drug conjugate (ADC) being developed for treating soft tissue sarcoma (STS). The company says the first-in-class ADC is designed to target urokinase plasminogen activator receptor-associated protein (uPARAP) conjugated to the Topoisomerase I inhibitor
Drugs
Nearly three out of four drug candidates that received an FDA breakthrough therapy designation (BTD) over the past decade eventually gained approval, according to a new analysis from investment firm Jefferies reported by BioSpace. The report examined 599 breakthrough designations issued between 2013 and year-to-date 2025, finding that
Drugs
FDA released on 10/8 a new table supporting the use of new approach methodologies and reduction in animal use in drug testing. An agency notice says the table contains an inventory of drug development contexts for which CDER is open to a streamlined nonclinical program. The notice says streamlined
Drugs
FDA has released the form FDA-483 with eight observations from an 8/25-9/5 inspection at the Aurobindo Pharma drug manufacturing facility in Bachupally, Hyderabad, India. The inspection observations were: * procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed,
Drugs
The D.C. federal court has rejected a Novartis suit challenging FDA’s approval of MSN’s ANDA for a generic version of Entresto (sacubitril /valsartan) with a carve-out of a patent-protected use. Attorney Sara Koblitz (Hyman, Phelps & McNamara) says MSN carved out a modified dosing regimen
Drugs
Age Reversal Unity, an advocacy organization founded in 2024 to lobby FDA to reclassify aging as a disease rather than a natural process, is petitioning the agency to create a regulatory pathway for so-called enhanced drugs, which it defines as “substances intended to make humans enhanced and superhuman, including
Drugs
Vivace Therapeutics has received an FDA fast track designation for its lead cancer drug VT3989, a first-in-class TEAD autopalmitoylation inhibitor being developed for patients with unresectable malignant mesothelioma that has progressed following treatment with an immune checkpoint inhibitor and platinum-based chemotherapy. Vivace is currently evaluating VT3989 in
Drugs
A 4/28-5/2 FDA inspection at the Naturich Cosmetique drug manufacturing facility in Garland, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/25 Warning Letter says the specific violations were: * failure to establish adequate written procedures for production and process
Drugs
FDA has issued Xspray Pharma a complete response letter on its NDA for Dasynoc (dasatinib) and its use for treating chronic myeloid leukemia and acute lymphoblastic leukemia. The letter cited GMP deviations at the company’s contract manufacturer, according to an Xspray release. The GMP issues do not involve Xspray’
Drugs
A federal judge has handed Eli Lilly a partial win in a lawsuit challenging FDA’s refusal to classify retatrutide — the company’s investigational obesity therapy — as a biological product. The U.S. District Court for the Southern District of Indiana ruled that while the agency acted lawfully in concluding
Drugs
AstraZeneca says its investigational drug baxdrostat met the primary endpoint in the Phase 3 Bax24 trial, showing a statistically significant and clinically meaningful reduction in 24-hour ambulatory systolic blood pressure compared with placebo in patients with resistant hypertension. The 12-week study found that baxdrostat significantly lowered blood pressure
Drugs
Thirteen Republican members of the House are calling on HHS secretary Robert F. Kennedy, Jr., to consider laying off CDER director George Tidmarsh, Office of Generic Drugs director Kathleen Uhl, and other agency staffers responsible for the recent approval of a generic form of the medical abortion drug mifepristone. In