Relay Therapeutics' zovegalisib receives FDA Breakthrough Therapy designation for PIK3CA-mutant HR+/HER2- advanced breast cancer, sending pre-market shares up over 3%.
Daiichi Sankyo Company Limited (DSKYF) and AstraZeneca's (AZN) supplemental Biologics License Application (sBLA) for Datroway has been granted Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of adults with metastatic triple-negative breast cancer (TNBC) who are not candidates...
AstraZeneca PLC (AZN) on Tuesday said the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics License Application (BLA) for Saphnelo for subcutaneous administration in adults with systemic lupus erythematosus (SLE). The company said it has since...
ARS Pharmaceuticals, Inc. (SPRY) said Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion supporting expanded marketing authorization for EURneffy to include a 1 mg nasal adrenaline spray. EURneffy 1 mg is proposed for the...
Exelixis, Inc. (EXEL) announced that its New Drug Application for zanzalintinib, in combination with atezolizumab, has been accepted for review in the U.S. for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and...
TuHURA Biosciences, Inc. (HURA) announced on Monday that the U.S. Food and Drug Administration has granted Orphan Drug Designation to its investigational therapy IFx-2.0 for the treatment of stage IIB to stage IV cutaneous melanoma. The designation was based on results from a Phase 1 study, which...
Aquestive Therapeutics (AQST) has received a Complete Response Letter from the FDA for the New Drug Application seeking approval of Anaphylm Sublingual Film for the treatment of Type I allergic reactions, including anaphylaxis, in patients weighing 30kg or more. In the CRL, which focuses on administration...
AstraZeneca PLC (AZN) on Monday said that its cancer immunotherapy Imfinzi, in combination with standard-of-care FLOT chemotherapy, has been recommended for approval by the Committee for Medicinal Products for Human Use (CHMP) in the European Union for the treatment of adults with resectable, early-stage...
Johnson & Johnson (JNJ) announced Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an indication extension for AKEEGA (niraparib and abiraterone acetate dual action tablet). The recommendation is for niraparib and abiraterone...
REGENXBIO (RGNX) announced that the FDA placed a clinical hold on its investigational gene therapy, RGX-111, for the treatment of MPS I, also known as Hurler syndrome, following preliminary analysis of a single case of neoplasm in a participant treated in its Phase I/II study. The FDA also placed a clinical...
Biogen, Inc. (BIIB) announced Wednesday that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for litifilimab (BIIB059) for the treatment of cutaneous lupus erythematosus (CLE). Litifilimab is a first in-class, humanized IgG1 monoclonal antibody (mAb) targeting...
Drug major Johnson & Johnson (JNJ) announced Tuesday that DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) -based quadruplet regimen has received the U.S. Food and Drug Administration approval to treat adult patients with newly diagnosed multiple myeloma or NDMM, who are ineligible for autologous...
Intellia Therapeutics (NTLA) announced that the FDA has removed the clinical hold on the Investigational New Drug application for the MAGNITUDE-2 Phase 3 clinical trial of nexiguran ziclumeran, or nex-z, for patients with hereditary transthyretin amyloidosis with polyneuropathy. The clinical holds on...
MannKind (MNKD) announced that the FDA has approved an update to the Prescribing Information for Afrezza Inhalation Powder, revising recommendations for the starting mealtime dosage when patients switch from subcutaneous mealtime insulin regimens. The updated labeling was supported by modeling data and...
BioArctic AB (BRCTF) announced on Monday that its partner Eisai (ESALY) has received Priority Review from the U.S. Food and Drug Administration (FDA) for the supplemental Biologics License Application (sBLA) for the Leqembi Iqlik subcutaneous autoinjector. The Prescription Drug User Fee Act (PDUFA)...
January 30, 2026 15:51 ET The Federal Reserve policy decision was the main event in the final week of January, which saw a heavy flow of economics news. Several data reflecting the trends in the U.S. economy were also released during the week. The interest rate decision from Canada also was in focus. In Europe, economic sentiment data gained attention. The policy decision from Singapore was the highlight in Asia.