Blog
RSS FeedPosted by Michael Wonder on 08 Feb 2026
FDA approves label update for Kite’s Yescarta for relapsed/refractory primary central nervous system lymphoma
6 February 2026 - FDA approves label update for Kite’s Yescarta for relapsed/refractory primary central nervous system lymphoma. ...
Posted by Michael Wonder on 07 Feb 2026
Pendopharm announces the approval of Yorvipath (palopegteriparatide injection) for the treatment of chronic hypoparathyroidism in adults
6 February 2026 - Pendopharm announced today that Health Canada has granted market authorisation for Yorvipath (palopegteriparatide injection), a parathyroid ...
Posted by Michael Wonder on 06 Feb 2026
Nucala (mepolizumab) approved by the European Commission for the treatment of chronic obstructive pulmonary disease
6 February 2026 - GSK today announced the European Commission has approved Nucala (mepolizumab), a monoclonal antibody targeting interleukin-5 , ...
Posted by Michael Wonder on 06 Feb 2026
Teva Canada announces approval of expanded indication of Ajovy (fremanezumab solution for subcutaneous injection), the first anti-CGRP preventive treatment for paediatric episodic migraine
4 February 2026 - Teva Canada announced today that Health Canada has approved an expanded indication for Ajovy (fremanezumab solution for ...
Posted by Michael Wonder on 06 Feb 2026
Merck announces Health Canada approval of Enflonsia for the prevention of RSV in newborns and infants
5 February 2026 - Approval is based on the CLEVER and SMART clinical trial results. ...
Posted by Michael Wonder on 06 Feb 2026
IBSA USA announces FDA approval of Vybrique, the first and only oral film to treat men with erectile dysfunction
5 February 2026 - US commercial availability anticipated in March 2026. ...
Posted by Michael Wonder on 04 Feb 2026
EURneffy 1 mg (adrenaline nasal spray) recommended for approval in the EU for emergency treatment of type 1 allergic reactions, including anaphylaxis in children weighing ≥15 kg to <30 kg
2 February 2026 - ARS Pharma’s partner, ALK-Abelló A/S, who owns the rights to market EURneffy in the EU, will distribute ...
Posted by Michael Wonder on 03 Feb 2026
Health Canada grants authorization for Bayer’s Hyrnuo (sevabertinib) for previously treated patients with locally advanced or metastatic HER2-mutant non-small cell lung cancer
2 February 2026 - Bayer is pleased to announce that Health Canada has authorized Hyrnuo (sevabertinib), oral tablets, for the treatment ...
Posted by Michael Wonder on 03 Feb 2026
Update on US regulatory review of Saphnelo subcutaneous administration in systemic lupus erythematosus
3 February 2026 - The US FDA issued a complete response letter regarding the biologics license application for Saphnelo (anifrolumab) for ...
Posted by Michael Wonder on 02 Feb 2026
Aquestive Therapeutics announces FDA issuance of complete response letter for Anaphylm
2 February 2026 - Deficiencies limited to packaging and administration. ...
Posted by Michael Wonder on 02 Feb 2026
Imfinzi perioperative raegimen recommended for approval in the EU by CHMP for patients with early gastric and gastro-oesophageal cancers
2 February 2026 - Recommendation based on MATTERHORN Phase III trial results which showed a 29% reduction in the risk of ...
Posted by Michael Wonder on 02 Feb 2026
Chiesi Global Rare Diseases and Protalix BioTherapeutics receive positive CHMP opinion for an additional dosing regimen of 2 mg/kg body weight every four weeks for Elfabrio (pegunigalsidase alfa) in the EU
30 January 2026 - Chiesi Global Rare Diseases and Protalix BioTherapeutics today announced an update on pegunigalsidase alfa. ...
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 01 Feb 2026
Sanofi’s Rezurock recommended for EU approval by the CHMP to treat chronic graft vs host disease
30 January 2026 - The EMA’s CHMP has adopted a positive opinion recommending the conditional marketing authorisation of Rezurock (belumosudil) in ...
Posted by Michael Wonder on 31 Jan 2026
Kygevvi (doxecitine and doxribtimine) recommended for approval in the European Union as treatment for thymidine kinase 2 deficiency
30 January 2026 - – UCB today announced that the CHMP of the EMA adopted a positive opinion recommending granting ...