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RSS FeedPosted by Michael Wonder on 09 May 2025
Itulatek approved for treatment of children and adolescents in Canada
8 May 2025 - ALK today announced that Health Canada has approved ALK’s regulatory filing for Itulatek (tree pollen sublingual allergy ...
Posted by Michael Wonder on 29 Apr 2025
Innorna announces FDA rare paediatric disease designation granted to IN013 for treatment of Wilson disease
25 February 2025 - Innorna is thrilled to announce that the US FDA has granted rare paediatric disease designation to ...
Posted by Michael Wonder on 17 Apr 2025
Neurelis announces FDA approval for immediate use seizure medication Valtoco (diazepam nasal spray) in age 2 to 5
16 April 2025 - Valtoco maintains orphan drug exclusivity for Valtoco to treat episodes of frequent seizures. ...
Posted by Michael Wonder on 08 Apr 2025
Teva announces FDA filing acceptance for Ajovy (fremanezumab) in paediatric episodic migraine prevention
7 April 2025 - If approved for an expanded paediatric indication, Ajovy would be the first calcitonin gene-related peptide antagonist for ...
Posted by Michael Wonder on 28 Mar 2025
Neurim Pharmaceuticals receives European marketing authorisation for paediatric prolonged-release melatonin (Slenyto) for the treatment of insomnia in children with ADHD
26 March 2025 - Neurim Pharmaceuticals announces that the European Commission has approved the extension of the indication to include ...
Posted by Michael Wonder on 12 Mar 2025
Atsena Therapeutics granted US FDA fast track designation for ATSN-201 gene therapy to treat X-linked retinoschisis
12 March 2025 - Marks third FDA designation for ATSN-201, which has also received rare paediatric disease designation and orphan drug ...
Posted by Michael Wonder on 12 Mar 2025
Sydnexis announces FDA acceptance of new drug application and PDUFA date for SYD-101 for the treatment of progression of paediatric myopia
11 March 2025 - Sydnexis today announced that the US FDA has accepted its new drug application for SYD-101 and ...
Posted by Michael Wonder on 08 Mar 2025
Acarizax approved in Canada for treatment of young children
7 March 2025 - ALK today announced that Health Canada has approved ALK’s Acarizax tablet for use in children, aged ...
Posted by Michael Wonder on 03 Mar 2025
Vertex receives CHMP positive opinion for expanded label for Kaftrio in combination with ivacaftor for people with cystic fibrosis to include rare mutations
28 February 2025 - If approved, approximately 4,000 people with cystic fibrosis in the European Union will be eligible for ...
Posted by Michael Wonder on 01 Mar 2025
Valneva receives EMA’s positive CHMP opinion for adolescent label extension for chikungunya vaccine Ixchiq
28 February 2025 - If granted, Ixchiq will become the first vaccine against the chikungunya virus available in the EU ...
Posted by Michael Wonder on 28 Feb 2025
FDA approves Odactra for the treatment of house dust mite allergy in young children
27 February 2025 - ALK today announced that the US FDA has approved ALK’s Odactra tablet for use in young children ...
Posted by Michael Wonder on 10 Jan 2025
ViGeneron announces FDA rare paediatric disease designation for VG901
8 January 2025 - ViGeneron today announced two important milestones for its novel gene therapy candidate VG901, to treat patients ...
Posted by Michael Wonder on 09 Jan 2025
Denali Therapeutics announces US FDA breakthrough therapy designation granted to tividenofusp alfa for the treatment of Hunter syndrome
8 January 2025 - Denali Therapeutics today announced that the US FDA has granted breakthrough therapy designation for tividenofusp alfa (DNL310) ...
Posted by Michael Wonder on 07 Jan 2025
Norgine submits marketing authorisation application to the EMA for eflornithine (difluoromethylornithine) in high risk neuroblastoma
6 January 2025 - Norgine today announced that it completed its marketing authorisation application filing to the EMA for eflornithine in ...
Posted by Michael Wonder on 26 Dec 2024
Rhythm Pharmaceuticals announces FDA approval of Imcivree (setmelanotide) for patients as young as 2 years old
20 December 2024 - Rhythm Pharmaceuticals today announced that the US FDA has approved an expanded indication for Imcivree (setmelanotide) to ...