PLYMOUTH MEETING, PA. — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to pitolisant for the treatment of Prader-Willi syndrome (PWS). “The decision to grant Orphan Drug designation to pitolisant indicates that it could be a promising treatment option...
treatment News
Chicago, Ill. – Scientists at Harvard University and the University of Illinois Chicago have developed an antibiotic that could give medicine a new weapon to fight drug-resistant bacteria and the diseases they cause. The antibiotic, cresomycin, described in Science, effectively suppresses pathogenic bacteria that have become resistant to many commonly...
CAMBRIDGE, Mass. & BEIJING – BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that BRUKINSA® (zanubrutinib) has been approved by Health Canada for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). “BRUKINSA is a highly selective BTK inhibitor designed to provide a deep...
MISSISSAUGA, Canada – Health Canada has granted a Notice of Compliance (NOC) for IMFINZI® (durvalumab), as monotherapy, for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT), following a priority review of the submission.1 The approval of...
MISSISSAUGA, ON – Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that Health Canada has granted market authorization for Columvi® (glofitamab for injection) in combination with gemcitabine and oxaliplatin (GemOx) indicated for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma not otherwise (DLBCL NOS)...
DUBLIN – Jazz Pharmaceuticals plc (NASDAQ: JAZZ) today announced the Health Canada approval and availability of Vyxeos® (daunorubicin and cytarabine liposome for injection) for the treatment of adults with newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).[1] AML, a cancer of the bone marrow and the blood, progresses rapidly without treatment.[2]...
TORONTO, Canada — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialisation of novel therapies for rare and ultra-rare genetic diseases, today announced that Health Canada has extended the approval of Evkeeza® (evinacumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies...
BOSTON – Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced Health Canada has granted Marketing Authorization for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF) in people ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, the most common CF-causing mutation....
OTTAWA, Canada — Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced that Health Canada has granted a marketing authorization for ANDEMBRY® (garadacimab) for routine prevention of attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. ANDEMBRY is a monoclonal antibody designed to target activated FXII (FXIIa),...
NEWTOWN, Pa. — Helius Medical Technologies, Inc. (NASDAQ: HSDT) is expanding its presence at the 2024 American Physical Therapy Association (APTA) Combined Sections Meeting (CSM), that will be held February 15 through February 17 at the Boston Convention and Exposition Center: In addition to exhibiting its innovative Portable Neuromodulation Stimulator...