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...
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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...
Sarasota, Florida — BIOM Pharmaceutical Corporation is thrilled to announce that Bi104, its innovative drug product, has been granted orphan-drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of Angelman syndrome (AS). Angelman Syndrome (AS) is a rare neurodevelopmental disorder characterized by developmental delay, intellectual disability,...
BOSTON, Mass. — Dewpoint Therapeutics, the leader in condensate biology, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to DPTX3186, its first-in-class condensate modulator for the treatment of gastric cancer. The designation follows the recent opening of Dewpoint’s Investigational New Drug (IND)...