Approvals
Novo Nordisk’s oral-semaglutide for type 2 diabetes snagged approval from the U.S. Food and Drug Administration late Friday, marking it as the first such treatment to be approved in pill form.
Merck had the unusual case of having its checkpoint inhibitor Keytruda (pembrolizumab) approved simultaneously in three countries for advanced endometrial carcinoma.
The U.S. Food and Drug Administration approved Keytruda in combination with Eisai’s Lenvima for the treatment of patients with advanced endometrial carcinoma.
Erleada is an androgen receptor inhibitor approved for non-metastatic castration-resistant prostate cancer.
Nucala is the only targeted biologic to be approved for the condition in the six to 11-year age group in the United States, the company said.
The approval marks the first commercial product for Xeris.
The U.S. Food and Drug Administration (FDA) gave the thumbs-up to Boehringer Ingelheim’s Ofev (nintedanib) for systemic sclerosis-associated interstitial lung disease (SSc-ILD).
The U.S. Food and Drug Administration (FDA) gave tentative approval to Mylan’s pemetrexed, a generic version of Eli Lilly’s $2 billion lung cancer drug, Alimta.
CrystalGenomics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CG-745, a clinical stage histone deacetylase (HDAC) inhibitor being developed for several hematologic malignancies and solid tumors, for the treatment of patients with pancreatic cancer.
Oncoceutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for ONC206, allowing the first-in-human trial of the compound. ONC206 is the first of the family of drug candidates, which we call “imipridones”, that possess the same core chemical structure as ONC201.
PRESS RELEASES