The National Medical Products Administration (NMPA) in China plays a crucial role in regulating drug approval and ensuring the safety and efficacy of pharmaceutical products. In 2023, the NMPA authorized the approval of 82 novel therapeutic agents, including 48 chemical drugs, 22 biological drugs, ...
FDA's Office of New Drugs (OND) approved 55 new drugs in 2023, with a little over half of those drugs for rare diseases. It’s the second highest amount since 2013 -- with 59 approvals in 2018 as the peak -- and is up from 37 new drugs in 2022. The 2023 OND Annual Report ...
first-in-class, and next-in-class drugs with all drugs (included cellular and gene therapies) approved in 2023 taken as 100%. Where available, the International Nonproprietary Name stems in drug names have been highlighted by underlining based on the WHO...
Breakthrough Therapy, when a drug shows significant improvement over available therapies based on a clinically significant endpoint; in this case, FDA commits rolling review process and guidance, enabling faster development of the product. In total, 70 novel drugs were approved in 2023 either by the...
BEIJING, July 5 (Xinhua) -- China approved the market launch of 24 innovative drugs in the first half of 2023, as the country implements a reform of the review and approval mechanisms for medical products, the National Medical Products Administration (NMPA) said Wednesday. ...
The FDA has approved fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) for unresectable or metastatic, HR-positive breast cancer with HER2-low or HER2-ultralow expression (IHC 1+ or 2+/ISH-, or IHC 0 with membrane staining, respectively), as determined by an FDA-approved test, in patie...
The purpose of this review is to provide an overview of the clinical uses and production techniques of 29 newly FDA-approved NCEs in 2023. Our intention is to offer a comprehensive understanding of the synthetic approaches employed in the creation of these drug molecules, with the aim of ...
2023new drugsFDAThe past year was a return to form for approvals of new drugs by the US Food and Drug Administration. There were 55 new molecular entities that cleared the FDA's hurdles in 2023. That number is up dramatically from the 37 the agency approved in 2022 and similar to the ...
Mounjaro, Relyvrio, and More: 9 New Drugs Approved in 2022 That You Should Know AboutWritten by Alyssa Billingsley, PharmD | Reviewed by Christina Aungst, PharmDPublished on March 7, 2023 print_outlinedemail_outlinedKey takeaways: In 2022, the FDA approved 37 novel (new) drugs. Over half...
The U. S. Food and Drug Administration( FDA) approved a 10-year high of 45 new molecular entities( NMEs) in 2015,including 33 new drug applications( NDAs) and 12 new biological applications( BLAs). Among these approvals,16 first-in-class drugs confirmed the creativity and 15 related thera...