USFDA

Cara Therapeutics and Vifor Pharma announced that the U.S. Food and Drug Administration has approved KORSUVA (difelikefalin) for injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis . KORSUVA injection is a first-in-class kappa opioid receptor (KOR) agonist that targets the body’s peripheral nervous system.

CAMBRIDGE, Mass., Aug. 17, 2021 (GLOBE NEWSWIRE)  Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism developing and delivering innovative treatments for genetically defined diseases announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for mitapivat for the treatment of adults with pyruvate kinase (PK) deficiency.

Moderna, Inc a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the emergency use authorization for the Moderna COVID-19 vaccine (mRNA-1273) to include a third dose for immunocompromised individuals 18 years of age or older in the United States who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

The U.S. Food and Drug Administration approved a new indication for Xywav for idiopathic hypersomnia in adults. IH is an uncommon chronic sleep disorder that causes people to be excessively sleepy during the day even after a good night's sleep. Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution is already approved for the treatment of cataplexy or excessive daytime sleepiness in patients seven years or older with narcolepsy.

Basel, 29 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for faricimab for the treatment of neovascular or wet age-related macular degeneration (nAMD) and diabetic macular edema (DME). The FDA has also accepted the company’s submission for diabetic retinopathy.

Saniona a clinical stage biopharmaceutical company focused on rare diseases announced that the U.S. Food and Drug Administration has granted orphan drug designation to Tesomet for the treatment of hypothalamic obesity. Tesomet is the first and only investigational treatment for HO to receive orphan drug designation. Saniona is preparing to initiate two Phase 2b studies of Tesomet in the second half of this year, one in HO and the other in Prader-Willi syndrome, for which Tesomet has already received orphan drug status.

Zydus Cadila has received tentative approval from the USFDA to market Ibrutinib Tablets, in the strengths of 140 mg, 280 mg, 420 mg and 560 mg. Ibrutinib belongs to a class of drugs known as kinase inhibitors and is used to treat certain cancers, such as mantle cell lymphoma or marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, and Waldenstrom's macroglobulinemia.