RedHill Biopharma Ltd. (RDHL) announced the FDA has granted rare pediatric disease designation to opaganib for treatment of neuroblastoma. The rare pediatric disease designation to opaganib provides for a Priority Review Voucher, subject to certain conditions. Opaganib has received Orphan Drug designation...
Pfizer, Inc. (PFE) announced Monday that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for HYMPAVZI (marstacimab-hncq) to include the treatment of patients with hemophilia A or B 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without...
Alvotech (ALVO), a biotechnology company, on Thursday said it has resubmitted Biologics License Applications (BLAs) to the U.S. Food and Drug Administration (FDA) for AVT05, a proposed biosimilar to Simponi and Simponi Aria, and AVT06, a proposed biosimilar to Eylea. The resubmissions follow the company's...
Pharming Group N.V. (PHAR) on Thursday said the U.S. Food and Drug Administration has accepted its resubmitted supplemental New Drug Application (sNDA) for Joenja to treat children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency. The...
Waters Corporation (WAT) on Wednesday said the BD BACTEC FXI Culture System has received U.S. Food and Drug Administration 510(k) clearance. The BD BACTEC FXI Culture System is a next-generation, fully automated blood culture system designed to improve the speed, consistency, and accuracy of bloodstream...
Lupin (500257, LUPIN) and its alliance partner Natco Pharma announced the approval from the FDA for Natco's Abbreviated New Drug Application for Eribulin Mesylate Injection, 1 mg/2 mL Single-Dose Vials. Eribulin Mesylate Injection is indicated for the treatment of adults with metastatic breast cancer...
Cingulate Inc. (CING) on Tuesday said the U.S. Food and Drug Administration has issued a Complete Response Letter for its New Drug Application seeking approval of CTx-1301 for the treatment of Attention Deficit/ Hyperactivity Disorder (ADHD). The company said the FDA's response identified specific...
Pasithea Therapeutics Corp. (KTTA) on Tuesday said the U.S. Food and Drug Administration has granted Orphan Drug Designation to its lead candidate, PAS-004, for the treatment of Amyotrophic Lateral Sclerosis (ALS), a progressive neurodegenerative disease that affects motor neurons. The company said...
Roche (RHHBY, RO.SW, ROG.SW) announced the FDA has accepted the company's New Drug Application under Priority Review for giredestrant, an investigational oral selective oestrogen receptor degrader, as an adjuvant treatment for adults with oestrogen receptor-positive, human epidermal growth factor receptor...
Vertex Pharmaceuticals Incorporated (VRTX) announced the FDA has accepted its Biologics License Application submission for povetacicept, an investigational engineered fusion protein and dual inhibitor of the BAFF and APRIL cytokines, in adults with immunoglobulin A nephropathy. The FDA has assigned a...
June's FDA calendar offers plenty for investors to keep a close eye on. Among the key names are Spero Therapeutics, awaiting an FDA decision on its antibiotic for complicated urinary tract infections; Kiniksa Pharma, seeking approval for a technology transfer of the manufacturing process for Arcalyst drug substance; and Merck, pursuing the first FDA approval for its WELIREG - KEYTRUDA combination.
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.