Blog
RSS FeedPosted 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 04 Nov 2022
Apellis announces plans to submit 24 month Phase 3 data to the FDA for pegcetacoplan NDA for geographic atrophy
3 November 2022 - Submission will be a major amendment to the new drug application, extending the review period by ...
Posted by Michael Wonder on 28 Oct 2022
US FDA defers action on filing for AT-GAA in late-onset Pompe disease
28 October 2022 - FDA issues deferred action letter on AT-GAA regulatory filing due to the inability to conduct required manufacturing ...
Posted by Michael Wonder on 26 Oct 2022
US FDA delays panel meet on Perrigo's OTC birth control pill
26 October 2022 - The US FDA has delayed a meeting of its advisory panel to discuss Perrigo's over the ...
Posted by Michael Wonder on 25 Oct 2022
IntelGenx receives FDA GDUFA date for Xiromed partnered development candidate, buprenorphine buccal film
25 October 2022 - IntelGenx today announced that its previously undisclosed development candidate, buprenorphine buccal film, for which an abbreviated ...
Posted by Michael Wonder on 25 Oct 2022
Hugel Aesthetics receives FDA acceptance of BLA resubmission for letibotulinumtoxinA for injection for glabellar lines
25 October 2022 - PDUFA goal date set for 6 April 2023. ...
Posted by Michael Wonder on 17 Oct 2022
Biogen announces FDA’s 3 month extension of review period for the new drug application for tofersen
17 October 2022 - The new Prescription Drug User Fee Act action date set by the FDA is 25 April ...
Posted by Michael Wonder on 04 Oct 2022
Split Real Time Application Review (STAR)
3 October 2022 - Under the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter, the FDA is creating the Split ...