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RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
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 05 Jun 2026
First new NHS treatment in over 20 years recommended for women with resistant ovarian cancer
4 June 2026 - The treatment uses a targeted therapy that seeks out a specific protein found on the surface of ...
Posted by Michael Wonder on 05 Jun 2026
Teva expands European biosimilars portfolio with launch of Ahzantive (aflibercept) biosimilar to Eylea
4 June 2026 - Teva Pharmaceutical Industries today announced the launch of Ahzantive (aflibercept), a biosimilar to Eylea, in Europe further ...
Posted by Michael Wonder on 05 Jun 2026
US FDA approves FoundationOne CDx as a companion diagnostic for Itovebi (inavolisib) to identify patients with hormone receptor positive, HER2 negative breast cancer with a PIK3CA mutation
2 June 2026 - Foundation Medicine today announced that it has received approval from the US FDA for FoundationOne CDx ...
Posted by Michael Wonder on 05 Jun 2026
J&J Innovative Medicine Korea wins reimbursement for Darzalex SC regimen in newly diagnosed AL amyloidosis
4 June 2026 - Johnson & Johnson Innovative Medicine Korea said Darzalex subcutaneous injection-based quadruple regimen has received reimbursement in ...
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
Biogen’s salanersen receives FDA breakthrough therapy designation for spinal muscular atrophy
4 June 2026 - Biogen announced today that the US FDA has granted salanersen breakthrough therapy designation for the treatment ...
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 ...