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RSS FeedPosted by Michael Wonder on 20 Feb 2024
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus chemotherapy as treatment for primary advanced or recurrent endometrial carcinoma
20 February 2024 - Acceptance based on results from the pivotal Phase 3 NRG-GY018 trial. ...
Posted by Michael Wonder on 20 Feb 2024
US FDA accepts supplemental new drug application for Krazati (adagrasib) in combination with cetuximab as a targeted treatment option for patients with previously treated KRAS G12C mutated locally advanced or metastatic colorectal cancer for priority review
20 February 2024 - BMS today announced that the US FDA has accepted for priority review the supplemental new drug ...
Posted by Michael Wonder on 19 Feb 2024
VivaGel BV US FDA appeal outcome
19 February 2024 - Starpharma today announces that it has completed the formal dispute resolution process with the US FDA in ...
Posted by Michael Wonder on 19 Feb 2024
Datopotamab deruxtecan biologics license application accepted in the US for patients with previously treated advanced non-squamous non-small cell lung cancer
19 February 2024 - Application based on results from the TROPION-Lung01 Phase 3 trial. ...
Posted by Michael Wonder on 18 Feb 2024
Sarepta Therapeutics announces US FDA acceptance of an efficacy supplement to expand the Elevidys indication
16 February 2024 - Priority review granted, with a review goal date of 21 June 2024. ...
Posted 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. ...