HENDERSON, Nev. – Spectrum Pharmaceuticals, a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for poziotinib for the treatment of non-small cell lung cancer (NSCLC) in previously treated patients with HER2 exon 20 mutations....
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SEATTLE, Wash. — Umoja Biopharma, the clinical-stage leader of in vivo cell therapies that aim to realize the full reach and promise of CAR T cells, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to UB-VV111 for the treatment of relapsed/refractory Large B-cell Lymphoma...
Calgary, Alberta — Zenith Epigenetics Ltd. (“Zenith” or the “Company”) is pleased to announce the designation of ZEN-3694 as a Fast Track product by the U.S. Food and Drug Administration (“FDA”). FDA officials concluded that ZEN-3694, in combination with abemaciclib, meets the criteria for Fast Track designation for the treatment...
THOUSAND OAKS, Calif.–– Amgen (NASDAQ: AMGN) announced today that the U.S. Food and Drug Administration (FDA) has granted full approval to IMDELLTRA® (tarlatamab-dlle) for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The decision to convert IMDELLTRA’s prior...
SAN DIEGO, Calif. and TOYKO, Japan — Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151) today announced the U.S. Food and Drug Administration (FDA) has granted full approval of KOMZIFTI™ (ziftomenib) for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible...
Ridgefield, Conn. — Boehringer Ingelheim today announced HERNEXEOS® (zongertinib tablets) has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for first-line treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations. “Exploring accelerated...
ISTURISA® is a cortisol synthesis inhibitor that blocks the enzyme 11β-hydroxylase to help normalize hypercortisolemia in Cushing’s syndrome, a rare endocrine condition that can have significant impact on patients and their families The expanded indication is supported by an extensive clinical development program Milan, Italy and Bridgewater, NJ, – Today...
Tokyo, Japan – The FDA on Tuesday approved the use of Takeda’s HyQvia (immune globulin infusion 10% with recombinant human hyaluronidase) as a treatment for chronic inflammatory demyelinating polyneuropathy. With the label expansion, HyQvia can now be given as a maintenance therapy to prevent the relapse of neuromuscular disability and...
DAVIS, Calif. — Infinant Health, a privately-held company focused on changing the trajectory of human health – one baby at a time – announced today that the U.S. Food and Drug Administration (FDA) has granted both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) to its investigational drug...
ROCKVILLE, Md. — NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted NT-I7 (efineptakin alfa) (rhIL-7-hyFc) Orphan Drug Designation (ODD) for the treatment of pancreatic cancer. Pancreatic cancer is an aggressive tumor-type associated with extremely poor prognosis. It is the...