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RSS FeedPosted by Michael Wonder on 15 Feb 2024
Citius Pharmaceuticals resubmits the biologics license application of Lymphir (denileukin diftitox) for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma
13 February 2024 - FDA acceptance of the completed resubmission package and issuance of a Prescription Drug User Fee Act ...
Posted by Michael Wonder on 15 Feb 2024
Dermavant submits supplemental new drug application to FDA for Vtama (tapinarof) 1% cream for the treatment of atopic dermatitis in adults and children 2 years of age and older
14 February 2024 - sNDA is supported by positive data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials ...
Posted by Michael Wonder on 14 Feb 2024
Rocket Pharmaceuticals announces update on FDA review timeline of Kresladi (marnetegragene autotemcel) for the treatment of severe leukocyte adhesion deficiency-I
13 February 2024 - New Prescription Drug User Fee Act date of 30 June 2024. ...
Posted by Michael Wonder on 14 Feb 2024
Galderma announces regulatory filing acceptance for nemolizumab in prurigo nodularis and atopic dermatitis in the US and EU
14 February 2024 - Nemolizumab was granted US FDA priority review for prurigo nodularis. ...
Posted by Michael Wonder on 14 Feb 2024
US FDA accepts for priority review Bristol Myers Squibb’s application for Augtyro (repotrectinib) for the treatment of patients with NTRK positive locally advanced or metastatic solid tumours
14 February 2024 - The US FDA assigned a target action date of 15 June 2024. ...
Posted by Michael Wonder on 12 Feb 2024
CymaBay announces FDA acceptance of NDA and priority review for seladelpar for the treatment of primary biliary cholangitis
12 February 2024 - FDA has granted priority review with a target PDUFA date of 14 August 2024. ...
Posted by Michael Wonder on 12 Feb 2024
FDA accepts Xspray Pharma’s NDA resubmission for Dasynoc
12 February 2024 - The US FDA has accepted the resubmission of Xspray Pharma’s new drug application for Dasynoc, following ...
Posted by Michael Wonder on 12 Feb 2024
FDA approves Takeda’s Eohilia (budesonide oral suspension), the first and only oral treatment in the US for eosinophilic oesophagitis
12 February 2024 - 12 weeks of treatment with Eohilia may address significant unmet needs of patients 11 years of age ...
Posted by Michael Wonder on 10 Feb 2024
Human acellular vessel biologics license application granted priority review by US FDA for the treatment of vascular trauma
9 February 2024 - PDUFA date set for 10 August 2024. ...
Posted by Michael Wonder on 10 Feb 2024
Lykos Therapeutics announces FDA acceptance and priority review of new drug application for MDMA assisted therapy for PTSD
9 February 2024 - PDUFA date is 11 August 2024. ...
Posted by Michael Wonder on 09 Feb 2024
Amneal announces complete response resubmission for IPX203 new drug application
8 February 2024 - Amneal Pharmaceuticals today announced that it has provided a complete response resubmission to the US FDA ...
Posted by Michael Wonder on 07 Feb 2024
Bristol Myers Squibb announces acceptance of US and EU regulatory filings for neo-adjuvant Opdivo (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo in resectable non-small cell lung cancer
7 February 2024 - Applications based on results from CheckMate-77T, the company’s second positive Phase 3 randomised trial with an immunotherapy-based ...
Posted by Michael Wonder on 07 Feb 2024
GSK’s RSV vaccine, Arexvy, accepted under priority review in US for the prevention of RSV disease in adults aged 50-59 at increased risk
6 February 2024 - Application supported by positive results of a Phase 3 trial showing immune response and acceptable tolerability profile ...
Posted by Michael Wonder on 06 Feb 2024
BridgeBio Pharma announces US FDA acceptance of new drug application for acoramidis for the treatment of patients with transthyretin amyloid cardiomyopathy
5 February 2024 - Accepted with Prescription Drug User Fee Act action date of 29 November 2024; the FDA not currently ...
Posted by Michael Wonder on 02 Feb 2024
Linvoseltamab receives EMA filing acceptance for treatment of relapsed/refractory multiple myeloma
2 February 2024 - Regeneron Pharmaceuticals today announced that the EMA has accepted for review the marketing authorisation application for linvoseltamab ...