New Drug Approvals in 2021
Novel Drug Approvals for 2021 - FDA
In 2021, CDER approved 50 new drugs, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics under ...
The FDA approved 50 novel drugs in 2021, including the first KRAS inhibitor for cancer and the first anti-amyloid antibody for Alzheimer's disease.
What are "Novel" Drugs? ... "Novel" drugs are new drugs never before approved or marketed in the U.S. See Drugs@FDA for information about all of ...
2021 drug approvals: In a year dominated by COVID, biopharma ...
The scoop: Ahead of its January 1 decision deadline at the FDA, Xeris Biopharma snagged a late December 2021 approval for Recorlev, a drug ...
Drugs approved in 2021 - C&EN - American Chemical Society
Adbry · Leqvio · Vyvgart · Tezspire · Cytalux · Livtencity · Voxzogo · Besremi ...
New Drugs Approved in 2021 - The American Journal of Medicine
In 2021, the US Food and Drug Administration (FDA) approved 50 novel drugs. Thirty-seven of the 50 (74%) novel drug approvals were reviewed and approved ...
The Pharmaceutical Industry in 2021. An Analysis of FDA Drug ...
In 2021, 50 drugs have been authorized, making it the fourth-best year after 2018 (59 drugs) and 1996 and 2020 (53 each). Regarding biologics, ...
New drug approvals for 2021: Synthesis and clinical applications
50 New drugs including 36 chemical entities and 14 biologics were approved by the U.S. Food and Drug Administration during 2021.
2021 in review: FDA approvals of new medicines - ScienceDirect.com
In total, 60 new molecular entities (NMEs) were approved by the FDA, the highest level achieved in the post-Prescription Drug User Fee (PDUFA) era and tied ...
10 Biggest Novel Drug Approvals of 2021 - BioSpace
In March, the FDA approved Genentech's Actemra (tocilizumab) for slowing the rate of decline in pulmonary function in adults with systemic ...
New drug approvals for 2021: Synthesis and clinical applications
50 New drugs including 36 chemical entities and 14 biologics were approved by the US Food and Drug Administration during 2021.
Novel Drugs Approved By FDA in 2021 - Biopharma PEG
During the whole year of 2021, the US FDA approved a total of 50 novel drugs. Judging from historical data, this figure ranks third in the past two decades.
New drug approvals held steady in 2021 - C&EN
Among the new approvals were 31 small molecules, accounting for 62% of the new drug pipeline. Notable new small-molecule drugs include a long- ...
New Drug Approvals in 2021: The Numbers and Trends
In 2020, 75% or 40 of the 53 NMEs were small molecules. In 2019, 79% of NME approvals were small molecules; in 2018, it was 71% and 74% in 2017.
New FDA Drug Approvals for 2024 - Drugs.com
New Drug Approvals ; Revuforj (revumenib) Tablets · Syndax Pharmaceuticals, Inc. · November 15, 2024 ; Kebilidi (eladocagene exuparvovec-tneq) Suspension for ...
2021 FDA approvals - Pharma Excipients
The FDA approved 50 novel drugs in 2021, including the first KRAS inhibitor for cancer and the first anti-amyloid antibody for Alzheimer's disease.
New Drugs Approved in 2021 - The American Journal of Medicine
Abstract. In 2021, the US Food and Drug Administration (FDA) approved 50 novel drugs. Thirty-seven of the 50 (74%) novel drug approvals were ...
FDA Approval of Drugs Not Meeting Pivotal Trial Primary End Points
In June 2021, the US Food and Drug Administration (FDA) granted accelerated approval to aducanumab for the treatment of Alzheimer disease ...
2021 FDA Approvals of Drugs for Cancer Treatment - The ASCO Post
The US Food and Drug Administration (FDA) granted approval to many novel drugs and new indications for older therapeutic agents used in oncology and hematology.
New Drug Approvals in China in 2021 - DIA Global Forum
In 2021, the NMPA CDE approved 29 Category 1 drugs, 27 of which were developed by local companies. This was a notable increase compared with 2020 (16 Category 1 ...