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RSS FeedPosted by Michael Wonder on 23 Apr 2024
Abeona Therapeutics provides regulatory update on Pz-cel
22 April 2024 - Abeona Therapeutics today announced a regulatory update for prademagene zamikeracel (pz-cel). ...
Posted by Michael Wonder on 23 Apr 2024
Acadia Pharmaceuticals announces trofinetide new drug submission for treatment of Rett syndrome has been accepted for filing and priority review by Health Canada
22 April 2024 - Acadia Pharmaceuticals today announced that Health Canada has accepted its new drug submission for trofinetide for the ...
Posted by Michael Wonder on 16 Apr 2024
GSK’s 5 in 1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA
16 April 2024 - Submission based on results from pivotal Phase III trial showing all primary outcomes met. ...
Posted by Michael Wonder on 16 Apr 2024
Norgine submits marketing authorisation application via Project Orbis for eflornithine (difluoromethylornithine) in high-risk neuroblastoma
15 April 2024 - Norgine today announced its first marketing authorisation application submissions on 10 April 2024, seeking approval for eflornithine ...
Posted by Michael Wonder on 10 Apr 2024
AB Science announces that Health Canada has granted eligibility for reconsideration request for masitinib in ALS
3 April 2024 - AB Science today announced that Health Canada has granted eligibility for reconsideration request for masitinib in ...
Posted by Michael Wonder on 10 Apr 2024
FDA accepts filing of new drug application for nalmefene auto-injector for the treatment of known or suspected opioid overdose
8 April 2024 - Purdue Pharma announced today that FDA has accepted for filing the company’s new drug application for the ...
Posted by Michael Wonder on 10 Apr 2024
Lundbeck and Otsuka submit sNDA for FDA review of brexpiprazole and sertraline combination as potential treatment for PTSD
9 April 2024 - Lundbeck and Otsuka have submitted a supplemental new drug application for US FDA review of brexpiprazole ...
Posted by Michael Wonder on 09 Apr 2024
Shorla Oncology announces FDA filing acceptance of new drug application to treat certain forms of leukaemia and other cancers
8 April 2024 - Second FDA acceptance for an NDA filing by Shorla Oncology announced in 2024. ...
Posted by Michael Wonder on 09 Apr 2024
Supernus provides regulatory update for SPN-830
8 April 2024 - Supernus Pharmaceuticals today announced a regulatory update for SPN-830. ...
Posted by Michael Wonder on 08 Apr 2024
Stealth BioTherapeutics announces FDA acceptance of new drug application for elamipretide for the treatment of Barth syndrome
8 April 2024 - If approved, elamipretide would become the first approved therapy for Barth syndrome. ...
Posted by Michael Wonder on 08 Apr 2024
ARS Pharmaceuticals submits response to FDA complete response letter for neffy (epinephrine nasal spray)
3 April 2024 - Submission of complete response letter response triggers up to six month review period by the FDA. ...
Posted by Michael Wonder on 04 Apr 2024
FDA accepts supplemental biologics license applications for Bimzelx (bimekizumab-bkzx) for moderate to severe hidradenitis suppurativa and additional 2 mL device presentations
4 April 2024 - Application in moderate to severe hidradenitis suppurativa based on results from two Phase 3 studies where ...
Posted by Michael Wonder on 04 Apr 2024
Rocket Pharmaceuticals announces EMA acceptance of RP-L102 marketing authorisation application for the treatment of Fanconi anaemia
2 April 2024 - Positive, previously disclosed results from the global Phase 1/2 trial demonstrated genetic and phenotypic correction combined ...
Posted by Michael Wonder on 03 Apr 2024
Zanidatamab biologics license application for previously treated HER2 positive metastatic biliary tract cancer completed
2 April 2024 - Zymeworks is pleased to announce, along with our partners Jazz Pharmaceuticals, completion of the rolling submission of ...
Posted by Michael Wonder on 03 Apr 2024
Autolus Therapeutics announces acceptance of marketing authorisation application by the EMA for obecabtagene autoleucel for patients with relapsed/refractory adult B-cell acute lymphoblastic leukaemia
2 April 2024 - Submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in r/r B-ALL. ...