Eisai Co. Ltd (ESALY.PK) and Biogen Inc. (BIIB) on Friday said the U.S. Food and Drug Administration has extended by three months the review of LEQEMBI IQLIK as a starting dose for the treatment of early Alzheimer's disease. The new Prescription Drug User Fee Act (PDUFA) action date is August 24,...
Armata Pharmaceuticals, Inc. (ARMP) on Thursday said the U.S. Food and Drug Administration has granted Fast Track designation to AP-SA02 for the adjunct treatment of complicated bacteremia caused by methicillin-sensitive and methicillin-resistant S. aureus. The company's shares were more than 9% up in pre-market trading.
Atossa Therapeutics, Inc. (ATOS) on Monday said the U.S. Food and Drug Administration has granted Rare Pediatric Disease designation to (Z)-endoxifen for the treatment of McCune-Albright Syndrome in females. McCune-Albright Syndrome is a rare genetic disorder caused by mutations in the GNAS gene,...
Axsome Therapeutics (AXSM) announced the FDA has approved AUVELITY for the treatment of agitation associated with dementia due to Alzheimer's disease. The FDA approval of AUVELITY is supported by a clinical program which included the Phase 3 ADVANCE-1 and ACCORD-2 studies. AUVELITY is a first-in-class...
AstraZeneca (AZN, AZN.L, ZEG.DE, AZN.ST) said the FDA's Oncologic Drugs Advisory Committee or ODAC has recognised a favourable benefit risk profile for AstraZeneca's Truqap in combination with abiraterone and androgen deprivation therapy for the treatment of patients with PTEN-deficient metastatic hormone-sensitive...
May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.