Blog
RSS FeedPosted by Michael Wonder on 11 Apr 2023
Abortion ruling could undermine the FDA’s drug approval authority
10 April 2023 - Legal scholars say the ruling by a Texas judge, if upheld, could spur disputes over many medications ...
Posted by Michael Wonder on 08 Apr 2023
Accord BioPharma announces US FDA acceptance of biologics license application for proposed biosimilar trastuzumab HLX02
5 April 2023 - The biosimilar for Herceptin seeks to treat several forms of HER2 cancer. ...
Posted by Michael Wonder on 08 Apr 2023
Federal judge stays FDA abortion pill approval, gives Biden administration time to appeal
7 April 2023 - A federal judge in Texas on Friday stayed the FDA’s approval of the abortion pill mifepristone, ...
Posted by Michael Wonder on 07 Apr 2023
Update on Imbruvica (ibrutinib) US accelerated approvals for mantle cell lymphoma and marginal zone lymphoma indications
6 April 2023 - AbbVie announced today the intent to voluntarily withdraw, in the US, accelerated Imbruvica (ibrutinib) approvals for ...
Posted by Michael Wonder on 07 Apr 2023
FDA Commissioner and Chief Scientist announce decision to withdraw approval of Makena
6 April 2023 - Today, the US FDA announced the final decision to withdraw approval of Makena—a drug that had been ...
Posted by Michael Wonder on 06 Apr 2023
Enanta Pharmaceuticals receives FDA fast track designation for EDP-323, its oral, L-protein inhibitor in development for the treatment of respiratory syncytial virus
6 April 2023 - Enanta Pharmaceuticals today announced that the US FDA has granted fast track designation for EDP-323, Enanta’s ...
Posted by Michael Wonder on 05 Apr 2023
Verismo Therapeutics secures fast track designation from the US FDA for SynKIR-110
5 April 2023 - SynKIR-110 addresses gaps in treatment options for those with malignant pleural mesothelioma, a rare and aggressive ...
Posted by Michael Wonder on 04 Apr 2023
FDA accepts Pfizer’s supplemental new drug applications for Braftovi + Mektovi
4 April 2023 - Supplemental new drug applications are supported by results from the PHAROS trial, evaluating the combination in ...
Posted by Michael Wonder on 04 Apr 2023
Shionogi receives US FDA fast track designation for ensitrelvir fumaric acid, an investigational oral anti-viral for COVID-19
4 April 2023 - Shionogi today announced that the US FDA has granted fast track designation for their investigational COVID-19 ...
Posted by Michael Wonder on 04 Apr 2023
FDA authorises Gohibic (vilobelimab) injection for the treatment of COVID-19
4 April 2023 - The FDA has issued an emergency use authorisation for the use of Gohibic (vilobelimab) injection for ...
Posted by Michael Wonder on 04 Apr 2023
HUTCHMED completes rolling submission of NDA to US FDA for fruquintinib for the treatment of refractory metastatic colorectal cancer
31 March 2023 - NDA supported by data from global Phase 3 FRESCO-2 study in the US, Europe, Japan and Australia ...
Posted by Michael Wonder on 03 Apr 2023
FDA grants accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial carcinoma
3 April 2023 - Today, the FDA granted accelerated approval to enfortumab vedotin-ejfv (Padcev, Astellas Pharma) with pembrolizumab (Keytruda, Merck) ...
Posted by Michael Wonder on 02 Apr 2023
Ensuring public trust in an empowered FDA
1 April 2023 - The FDA’s recent approval of lecanemab for Alzheimer’s disease has been clouded by controversy over other accelerated ...
Posted by Michael Wonder on 30 Mar 2023
Renovion receives FDA fast track designation for ARINA-1 for the prevention of BOS progression in lung transplant patients
30 March 2023 - Renovion announced today that the US FDA has granted fast track designation to ARINA-1 for the prevention ...
Posted by Michael Wonder on 30 Mar 2023
FDA converts to full approval indication for Keytruda (pembrolizumab) for certain adult and paediatric patients with advanced microsatellite instability-high or mismatch repair deficient solid tumours
29 March 2023 - Merck today announced that the US FDA has granted full approval to Keytruda, Merck’s anti-PD-1 therapy, for ...