SANTA MONICA, Calif. – Kite, a Gilead Company (Nasdaq: GILD), announced the U.S. Food and Drug Administration (FDA) has granted approval for Tecartus® (brexucabtagene autoleucel) for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Following FDA Breakthrough Therapy Designation...
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FOSTER CITY, Calif. – Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leader in rare liver disease, announced that the U.S. Food and Drug Administration (FDA) has approved LIVMARLI™ (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) one year of age and older. LIVMARLI, a...
VANCOUVER, Canada – BirchBioMed Inc., a leading clinical stage biopharmaceutical company, expert in the development of products for scarring and other fibrosis-related disorders and autoimmune therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to FS2 (kynurenic acid) for the investigational treatment of idiopathic pulmonary...
MADRID, Spain — Amadix, a Spanish biotech company, announced today that PreveCol®, its colorectal cancer screening blood test, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). With this milestone, Amadix becomes the first European company to announce this recognition for early detection of colorectal cancer....
CAMBRIDGE, Mass. & BEIJING – BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that BRUKINSA® (zanubrutinib) has received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory...
CAMBRIDGE, Mass. & BEIJING – BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that BRUKINSA® (zanubrutinib) has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). “We...
PARIS, FRANCE, 13 JANUARY 2026 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for IPN60340 in combination with venetoclax and azacitidine (Ven-Aza) in first line unfit acute myeloid leukemia, an aggressive blood cancer affecting older adults. IPN60340...
HYOGO, Japan — JCR Pharmaceuticals Co., Ltd. Chairman and President Shin Ashida announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) to JR-441, an investigational drug for the treatment of mucopolysaccharidosis type IIIA (MPS IIIA, or Sanfilippo syndrome type A). JR-441 is a blood-brain barrier...
NEW YORK, NY — Paige, a leader in next-generation AI technology, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to Paige PanCancer Detect*, an AI-assisted diagnostic application intended to assist pathologists in the detection of foci that are suspicious for cancer across a...
EMERYVILLE, Calif. — Eureka Therapeutics, Inc., a clinical-stage biotechnology company advancing next-generation T-cell therapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to ECT204, a GPC3-targeting ARTEMIS® CAR T-cell therapy, for the treatment of patients with advanced hepatocellular carcinoma...