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RSS FeedPosted 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 ...
Posted by Michael Wonder on 09 Aug 2022
Reata Pharmaceuticals announces three month extension of the review period for new drug application for omaveloxolone for the treatment of Friedreich’s ataxia
9 August 2022 - PDUFA date extended to 28 February 2023. ...
Posted by Michael Wonder on 01 Aug 2022
Scynexis announces U.S. FDA acceptance and priority review of the supplemental new drug application for Brexafemme (ibrexafungerp) for prevention of recurrent vaginal yeast infections
1 August 2022 - Submission has been granted priority review and given a target regulatory decision date of 30 November 2022. ...
Posted by Michael Wonder on 27 Jul 2022
FDA explains the ins and outs of real-time oncology review program in new guidance
26 July 2022 - Cancer drugs under development that show substantial promise over existing therapies and have simple study designs, as ...
Posted by Michael Wonder on 14 Jul 2022
BeiGene provides regulatory update on the U.S. biologics license application for PD-1 inhibitor tislelizumab in second-line oesophageal squamous cell carcinoma
14 July 2022 - Due to COVID travel restrictions, inspections could not be completed during review period. ...
Posted by Michael Wonder on 20 Jun 2022
FDA caught up on domestic pre-approval inspections, foreign inspections still a challenge
20 June 2022 - The US FDA eliminated its backlog of overdue domestic pre-approval inspections, yet such progress has been ...
Posted by Michael Wonder on 13 Jun 2022
BeiGene announces PDUFA goal date extension for U.S. sNDA for Brukinsa for the treatment of CLL/SLL
13 June 2022 - Following additional data submission to FDA demonstrating ORR superiority over ibrutinib as determined by IRC, PDUFA goal ...