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RSS FeedPosted by Michael Wonder on 05 May 2026
Satellite Bio announces FDA rare paediatric disease designation for SB-101 for the treatment of urea cycle disorders
4 May 2026 - Satellite Biosciences today announced that the US FDA has granted rare paediatric disease designation for SB-101 for ...
Posted by Michael Wonder on 05 May 2026
Atossa Therapeutics receives FDA rare paediatric disease designation for (Z)-endoxifen for McCune-Albright syndrome
4 May 2026 - Atossa Therapeutics today announced that the US FDA has granted rare paediatric disease designation to (Z)-endoxifen for ...
Posted by Michael Wonder on 02 May 2026
Stelara paediatric Crohn’s disease FDA approval J&J statement
1 May 2026 - On 15 April 2026, the US FDA approved Stelara (ustekinumab) for the treatment of patients two ...
Posted by Michael Wonder on 22 Apr 2026
Sanofi's Tzield approved in the US to delay the onset of stage 3 type 1 diabetes in young children
22 April 2026 - The US FDA has approved the supplemental biologic license application for Tzield (teplizumab-mzwv), expanding the indication ...
Posted by Michael Wonder on 22 Apr 2026
Dupixent (dupilumab) approved in the US as the first biologic medicine for young children with uncontrolled chronic spontaneous urticaria
22 April 2026 - Approval for children aged 2 to 11 years with chronic spontaneous urticaria who remain symptomatic despite H1 ...
Posted by Michael Wonder on 22 Apr 2026
Star Therapeutics receives FDA rare paediatric disease and breakthrough therapy designations for VGA039 in von Willebrand disease prophylaxis
21 April 2026 - VGA039 is a once monthly, subcutaneously self-administered investigational therapy for the treatment of bleeding disorders, initially being ...
Posted by Michael Wonder on 28 Mar 2026
Egetis announces FDA acceptance and priority review of NDA for Emcitate (tiratricol) for MCT8 feficiency
27 March 2026 - Egetis Therapeutics today announced that the US FDA has accepted the filing of its new drug application ...
Posted by Michael Wonder on 13 Mar 2026
Novartis Cosentyx receives FDA approval for paediatric patients aged 12+ with moderate to severe hidradenitis suppurativa
13 March 2026 - Novartis announced today that Cosentyx (secukinumab) received US FDA approval for treating paediatric patients 12 years ...
Posted by Michael Wonder on 28 Feb 2026
FDA approves Novo Nordisk's Sogroya as the first and only once weekly, long-acting growth hormone for three additional paediatric indications
27 February 2026 - Novo Nordisk today announced that the US FDA has approved three new indications for once weekly Sogroya ...
Posted by Michael Wonder on 28 Feb 2026
FDA approves once weekly Yuwivel (navepegritide) for children with achondroplasia aged 2 years and older
27 February 2026 - Rare paediatric disease priority review voucher granted in connection with approval. ...
Posted by Michael Wonder on 02 Feb 2026
Pharming Group receives complete response letter from US FDA for sNDA for Joenja (leniolisib) in children aged 4 to 11 years with APDS
1 February 2026 - Pharming today announced that the US FDA has issued a complete response letter to its supplemental ...
Posted by Michael Wonder on 12 Jan 2026
FDA approves first treatment for children with Menkes disease
12 January 2026 - The US FDA today approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease ...
Posted by Michael Wonder on 05 Jan 2026
Sanofi’s Tzield accepted for priority review in the US for young children with stage 2 type 1 diabetes
5 January 2026 - The US FDA has accepted for priority review the supplemental biologic license application for Tzield (teplizumab-mzwv) to ...
Posted by Michael Wonder on 13 Dec 2025
BioCryst announces FDA approval of Orladeyo (berotralstat) oral pellets, first and only oral prophylactic treatment for patients with HAE aged 2 to <12 years
12 December 2025 - BioCryst Pharmaceuticals today announced that the US FDA has approved its new drug application for the ...
Posted by Michael Wonder on 08 Dec 2025
House passes bill that reauthorises the FDA’s paediatric priority voucher pathway
2 December 2025 - The US House of Representatives has passed a new piece of legislation that reauthorises the US ...