Blog
RSS FeedPosted by Michael Wonder on 20 Jun 2024
KalVista submits new drug application to FDA for sebetralstat as first oral on-demand treatment for hereditary angioedema
18 June 2024 - KalVista Pharmaceuticals today announced the submission of a new drug application for US FDA review of ...
Posted by Michael Wonder on 23 May 2024
COTA announces extended collaboration with FDA to advance the use of real world data in cancer research
22 May 2024 - Today, COTA announced an extension of its research collaboration with the US FDA Oncology Center of Excellence. ...
Posted by Michael Wonder on 20 May 2024
Overall survival benefits of cancer drugs initially approved by the US FDA on the basis of immature survival data: a retrospective analysis
13 May 2024 - New cancer drugs can be approved by the US FDA on the basis of surrogate endpoints while ...
Posted by Michael Wonder on 25 Apr 2024
US FDA accepts for priority review GSK’s application for an expanded indication of Jemperli (dostarlimab) plus chemotherapy to include all adult patients with primary advanced or recurrent endometrial cancer
24 April 2024 - 23 August 2024 assigned as Prescription Drug User Fee Act action date for FDA decision. ...
Posted by Michael Wonder on 29 Sep 2023
Merck receives priority review from FDA for new biologics license application for sotatercept, an activin signaling inhibitor to treat adults with pulmonary arterial hypertension
28 September 2023 - Application based on clinically meaningful results from the Phase 3 STELLAR trial. ...
Posted by Michael Wonder on 29 Jun 2023
US FDA approves BioMarin's Roctavian (valoctocogene roxaparvovec-rvox), the first and only gene therapy for adults with severe haemophilia A
29 June 2023 - Roctavian's approval was based on durability, efficacy and safety results from the largest and longest Phase 3 ...
Posted by Michael Wonder on 28 Jun 2023
FDA approves Bayer’s Ultravist (iopromide) injection for contrast-enhanced mammography
23 June 2023 - Ultravist-300, -370 is now the only contrast agent in the US indicated to visualise known or suspected ...
Posted by Michael Wonder on 20 Jun 2023
FDA launches pilot program to help reduce risks associated with using laboratory developed tests to identify cancer biomarkers
20 June 2023 - Pilot geared toward sponsors of certain oncology drug products used with certainin vitro diagnostic tests ...
Posted by Michael Wonder on 07 Jun 2023
Legend Biotech announces submission of supplemental application to the US FDA for expanded use of Carvykti (ciltacabtagene autoleucel)
6 June 2023 - The application is supported by the Phase 3 CARTITUDE-4 study, which showed significant improvement in primary endpoint ...
Posted by Michael Wonder on 18 Dec 2022
FDA approves first gene therapy for the treatment of high risk, non-muscle invasive bladder cancer
16 December 2022 - Today, the US FDA approved Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating adenoviral vector based gene therapy indicated for ...
Posted by Michael Wonder on 15 Sep 2022
Opsens announces FDA clearance for the SavvyWire for use in transcatheter aortic valve replacement procedures
15 September 2022 - OpSens today announced that it has received 510(k) regulatory clearance from the US FDA for the SavvyWire, ...
Posted by Michael Wonder on 24 May 2022
FDA accepts CSL Behring's biologics license application for etranacogene dezaparvovec for priority review
24 May 2022 - If approved, etranacogene dezaparvovec would be the first gene therapy option for people living with haemophilia B. ...
Posted by Michael Wonder on 06 Jul 2021
Athenex provides update from FDA Type A meeting regarding oral paclitaxel plus encequidar for the treatment of metastatic breast cancer
6 July 2021 - Athenex today announced that the Company held a Type A meeting with the U.S. FDA during the ...
Posted by Michael Wonder on 04 Jun 2021
FDA approves first treatment for patients with plasminogen deficiency, a rare genetic disorder
4 June 2021 - Today, the U.S. FDA approved Ryplazim (plasminogen, human-tmvh) for the treatment of patients with plasminogen deficiency type ...
Posted by Michael Wonder on 26 May 2021
Varian receives FDA breakthrough device designation for its cardiac radioablation system for treatment of refractory ventricular tachycardia
26 May 2021 - Varian's CRA system has been designated a "breakthrough device" by the FDA because of its potential to ...