[6] Alnylam Announces U.S. Food and Drug Administration Acceptance of New Drug Application for Investigational Vutrisiran for the Treatment of the Polyneuropathy of Hereditary ATTR Amyloidosis. Retrieved March 28, 2022 from, https:// investors.alnylam.com/press-release?id=25811 [7] Fourth Quarter...
WASHINGTON, Aug. 10 (Xinhua) -- The United States Food and Drug Administration (FDA) approved on Friday for the first time a new class of drugs called small interfering RNA treatment. The agency gave a green light to Onpattro infusion for the treatment of peripheral nerve disease caused by...
[6] Alnylam Announces U.S. Food and Drug Administration Acceptance of New Drug Application for Investigational Vutrisiran for the Treatment of the Polyneuropathy of Hereditary ATTR Amyloidosis. Retrieved March 28, 2022 from,https://investors.alnylam.com/press-release?id=25811 [7] Fourth Quarter an...
Approved for the treatment of heart disease caused by transthyretin-mediated amyloidosis (ATTR-CM) in adult patients. Company Name: Pfizer, Inc. PIQRAY® Active Ingredient: alpelisib Approved for the treatment of postmenopausal women, and men, with hormone receptor-positive, human epidermal growth ...
In April, the FDA’s schedule remains busy,with a potential of four drugs to be approved within the month. (By WuXi AppTec content team.Click the image to view at full size) 1. Drug: mavacamten Company: Bristol Myers Squibb
FDA. FDA grants accelerated approval to Darzalex Faspro for newly diagnosed light chain amyloidosis. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-darzalex-faspro-newly-diagnosed-light-chain-amyloidosis (2021). FDA. FDA approves crizotinib for ALK-positive...
Pharmacokinetics of Patisiran, the First Approved RNA Interference Therapyin Patients With HereditaryTransthyretin-Mediated Amyloidosis ◾分子结构 FDA label Patisiran 2018 2 Patisiran 主要药效学 ◾体外和体内试验 FDA review of Patisiran. 2018 3 Patisiran 次要药效学 ...
10. Vyndaqel tafamidis meglumine 5/3/2019 To treat heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults 9. Skyrizi risankizumab-rzaa 4/23/2019 To treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy...
See Drugs@FDA for information about all of CDER’s approved drugs and biological products. Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that FDA had not previously approved, either as a single ...
2023,CDER also approved many therapies for rare cancers or tumors,including:Mantle cell lymphoma,an aggressive form of non-Hodgkins lymphoma.Nasopharyngeal carcinoma,a rare head and neck cancer.Large B-cell lymphoma.Desmoid tumors,noncancerous growths in the connective tissue.*Not all drugs for ra...