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RSS FeedPosted by Michael Wonder on 09 Jun 2026
US FDA accepts Takeda's application for intravenous Entyvio (vedolizumab) in paediatric ulcerative colitis and Crohn's disease
9 June 2026 - Takeda today announced the US FDA has accepted for review its supplemental biologics license application for intravenous ...
Posted by Michael Wonder on 09 Jun 2026
Health Canada authorizes Lunsumio (mosunetuzumab) for the treatment of relapsed or refractory follicular lymphoma after two or more systemic therapies
8 June 2026 - Roche Canada is pleased to announce that Health Canada has granted market authorisations for Lunsumio (mosunetuzumab ...
Posted by Michael Wonder on 09 Jun 2026
Sarclisa subcutaneous approved in the EU as the first anticancer treatment administered via an on-body injector
8 June 2026 - The European Commission has approved Sarclisa (isatuximab) subcutaneous in combination with standard of care regimens for the ...
Posted by Michael Wonder on 09 Jun 2026
Alvotech announces FDA acceptance of biologics license application for AVT16, a proposed interchangeable biosimilar to Entyvio
8 June 2026 - Alvotech today announced that the US FDA has accepted for review a biologics license application for ...
Posted by Michael Wonder on 08 Jun 2026
US FDA approves Pfizer’s Hympavzi for the treatment of two additional haemophilia A or B patient populations with significant medical need
8 June 2026 - Pfizer today announced that the US FDA has approved an expanded indication for Hympavzi (marstacimab-hncq) to include ...
Posted by Michael Wonder on 07 Jun 2026
Boan Biotech submits a biologics license application for two denosumab biosimilars in the US
29 May 2026 - Boan Biotech announced today that it has submitted a biologics license application to the US FDA for ...
Posted by Michael Wonder on 06 Jun 2026
Xspray Pharma receives CRL from US FDA for Nilopki
4 June 2026 - Xspray Pharma has received a complete response letter from the US FDA for its new drug application ...
Posted by Michael Wonder on 06 Jun 2026
Adjuvanted trivalent influenza vaccine authorised for adults aged 50 and over
4 June 2026 - The MHRA has today granted a marketing authorisation for the adjuvanted trivalent influenza vaccine (Aujemflu) to protect ...
Posted by Michael Wonder on 06 Jun 2026
Chiesi Global Rare Diseases announces European Commission approval of Lojuxta (lomitapide) capsules for paediatric use in homozygous familial hypercholesterolaemia
5 June 2026 - Chiesi Global Rare Diseases today announced that the European Commission has approved lomitapide capsules for use in ...
Posted by Michael Wonder on 06 Jun 2026
IntraBio announces submission of variation application to the EMA for Aqneursa for ataxia-telangiectasia
5 June 2026 - IntraBio Inc. today announced the submission of a variation application to the EMA to expand the ...
Posted by Michael Wonder on 05 Jun 2026
Kashiv BioSciences announces validation and acceptance of market authorisation application by Health Canada for ADL-018, a proposed biosimilar to Xolair (omalizumab)
4 June 2026 - Kashiv BioSciences today announced that Health Canada has validated and accepted the marketing authorisation application for ADL-018, ...
Posted by Michael Wonder on 04 Jun 2026
Pharming announces US FDA acceptance of sNDA resubmission for Joenja (leniolisib) to treat children aged 4 to 11 years with APDS
4 June 2026 - Pharming today announced that the US FDA has accepted its resubmitted supplemental new drug application seeking approval ...
Posted by Michael Wonder on 04 Jun 2026
Resmetirom (Rezdiffra) authorised to treat metabolic dysfunction-associated steatohepatitis in adults
3 June 2026 - The MHRA has today authorised the medicine resmetirom (Rezdiffra) to treat adult patients with metabolic dysfunction-associated steatohepatitis. ...
Posted by Michael Wonder on 04 Jun 2026
European Commission approves Amgen's Imdylltra for the treatment of extensive-stage small cell lung cancer
1 June 2026 - Amgen today announced that the European Commission has granted marketing authorisation for Imdylltra (tarlatamab) as a ...
Posted by Michael Wonder on 04 Jun 2026
AbbVie announces European Commission approval of Aquipta (atogepant) for the acute treatment of migraine in adults
2 June 2026 - AbbVie today announced that the European Commission has approved Aquipta (atogepant) for the acute treatment of migraine ...