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RSS FeedPosted 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 ...
Posted by Michael Wonder on 02 Dec 2025
Solid Biosciences receives FDA rare paediatric disease designation for SGT-212 dual route of administration gene therapy for Friedreich’s ataxia
1 December 2025 - Solid Biosciences today announced that it received rare paediatric disease designation from the US FDA for SGT-212, ...
Posted by Michael Wonder on 01 Nov 2025
Johnson & Johnson submits application to US FDA for Stelara (ustekinumab) in the treatment of paediatric ulcerative colitis
31 October 2025 - Expanded Stelara indication seeks to treat children two years of age and older with moderately to severely ...
Posted by Michael Wonder on 28 Oct 2025
Cellectar Biosciences receives rare paediatric disease designation from US FDA for iopofosine I 131 in relapsed or refractory paediatric high-grade glioma
27 October 2025 - Cellectar Biosciences today announced the US FDA has granted rare paediatric drug designation for iopofosine I ...
Posted by Michael Wonder on 14 Oct 2025
MannKind announces US FDA accepts for review its supplemental biologics license application for inhaled ansulin (Afrezza) in children and adolescents aged 4-17 years living with diabetes
13 October 2025 - MannKind Corporation today announced that the US FDA has accepted the supplemental biologics license application seeking approval ...
Posted by Michael Wonder on 08 Oct 2025
US FDA approves Simponi (golimumab) for the treatment of paediatric ulcerative colitis
7 October 2025 - Johnson & Johnson today announced that the US FDA has approved Simponi (golimumab) for the treatment of ...
Posted by Michael Wonder on 07 Oct 2025
FDA approves Arcutis’ Zoryve (roflumilast) cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5
6 October 2025 - Commercial product expected to be available by the end of October 2025. ...