Blog
RSS FeedPosted by Michael Wonder on 17 Feb 2023
Pharming provides update on EMA regulatory review of leniolisib for APDS in Europe
16 February 2023 - EMA marketing authorisation application for leniolisib changed to standard review timetable. ...
Posted by Michael Wonder on 13 Feb 2023
Like Medicare, the PBS urgently needs overhauling – for all our sakes
10 February 2023 - Trent Zimmerman says it would be a mistake for Australia to narrow its health reform agenda ...
Posted by Michael Wonder on 08 Feb 2023
Speeding up access to new medicines in Scotland: abbreviated process
8 February 2023 - A process brought in to streamline decision-making around access to new medicines in NHSScotland during the ...
Posted by Michael Wonder on 30 Jan 2023
argenx receives notification of PDUFA date extension for SC efgartigimod
27 January 2023 - argenx today announced that the US FDA has extended the review of the biologics license application ...
Posted by Michael Wonder on 26 Jan 2023
Draft methods (version 7.0): IQWiG is extending the comment period
26 January 2023 - The new deadline is 28 February 2023. ...
Posted by Michael Wonder on 09 Jan 2023
Krystal Biotech announces FDA’s 3 month extension of BLA PDUFA date and regulatory update for B-VEC to treat patients with dystrophic epidermolysis bullosa
9 January 2023 - Krystal Biotech today announced that on 5 January 2023, the US FDA notified the Company that ...
Posted by Michael Wonder on 22 Dec 2022
Update on US regulatory status of AVT02, Alvotech’s proposed high concentration, interchangeable biosimilar to Humira
22 December 2022 - US FDA has confirmed that the goal date for an approval decision on Alvotech’s license application for ...
Posted by Michael Wonder on 22 Dec 2022
US FDA extends review of Pfizer’s new drug application for Paxlovid
20 December 2022 - Pfizer oral treatment remains available to eligible US patients under emergency use authorisation as a critical ...
Posted by Michael Wonder on 15 Dec 2022
Update on US regulatory priority review of Lynparza in combination with abiraterone in metastatic castration-resistant prostate cancer
15 December 2022 - AstraZeneca and MSD today announced that the US FDA has informed AstraZeneca that it will extend ...
Posted by Michael Wonder on 22 Nov 2022
IntelGenx receives FDA PDUFA date for Rizafilm
22 November 2022 - IntelGenx today announced that the US FDA has accepted for review its Class 2 response to the ...
Posted by Michael Wonder on 22 Nov 2022
Gamida Cell provides regulatory update on omidubicel
21 November 2022 - Recent company submission in response to FDA request extends PDUFA date by three months. ...
Posted by Michael Wonder on 19 Nov 2022
Iovance Biotherapeutics provides update on biologics license application submission for lifileucel in advanced melanoma
18 November 2022 - BLA submission on-going with US FDA. ...
Posted by Michael Wonder on 19 Nov 2022
Apellis announces FDA acceptance of NDA amendment and new PDUFA date of 26 February 2023 for pegcetacoplan for geographic atrophy
18 November 2022 - Apellis Pharmaceuticals today announced that the US FDA has accepted Apellis’ unsolicited major amendment to the new ...
Posted by Michael Wonder on 08 Nov 2022
BioMarin announces incremental progress on biologics license application review for valoctocogene roxaparvovec AAV gene therapy for adults with severe haemophilia A program
7 November 2022 - FDA requests submission of upcoming 3 year data analysis from Phase 3 GENEr8-1 trial. ...
Posted by Michael Wonder on 06 Nov 2022
Kiwis with rare disorders want faster progress on 'life or death' health strategy
6 November 2022 - For Samantha Lenik, being diagnosed with Pompe disease after seven years of symptoms was a “double-edged ...