26 June 2024 - Today, the FDA granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab), a bispecific CD20 directed CD3 T-cell ...
13 June 2024 - Today, the FDA granted accelerated approval to repotrectinib (Augtyro, BMS) for adult and paediatric patients 12 ...
10 June 2024 - Approval based on positive Phase 3 ELATIVE trial data. ...
16 May 2024 - Today, the FDA granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen) for extensive stage small cell lung ...
15 May 2024 - Today, the FDA granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics) for adults with relapsed ...
7 May 2024 - In this cohort study of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did ...
23 April 2024 - Gene editing and therapy to replace missing or defective genes is one of the most exciting ...
24 April 2024 - The FDA’s accelerated approval program aims to speed “approval of drugs that treat serious conditions, and ...
1 December 2023 - Today, the FDA granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly) for adults with chronic lymphocytic ...
21 November 2023 - Most people probably assume that all prescription drugs on the US market have been proven effective in ...
9 September 2023 - Implementation of the accelerated approval program has been rocky in recent years. ...
14 August 2023 - Today, the FDA granted accelerated approval to elranatamab-bcmm (Elrexfio, Pfizer), a bispecific B-cell maturation antigen directed ...
10 August 2023 - On 9 August 2023, the FDA granted accelerated approval to talquetamab-tgvs (Talvey, Janssen Biotech) for adults with ...
15 May 2023 - Accelerated approvals have helped get promising therapies to market fast — but follow-up research to confirm that ...
3 April 2023 - Today, the FDA granted accelerated approval to enfortumab vedotin-ejfv (Padcev, Astellas Pharma) with pembrolizumab (Keytruda, Merck) ...