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RSS FeedPosted by Michael Wonder on 03 Jun 2026
Celltrion files for approval of Cosentyx biosimilar, CT-P55, in Canada
1 June 2026 - Celltrion announced on Monday that it has submitted a regulatory application to Health Canada for CT-P55, ...
Posted by Michael Wonder on 02 Jun 2026
FDA accepts new drug application for Roche’s giredestrant in oestrogen receptor positive early-stage breast cancer, the first and only oral SERD with positive phase III results in the curative setting
2 June 2026 - Roche announced today that the US FDA has accepted the company’s new drug application under priority review ...
Posted by Michael Wonder on 02 Jun 2026
Zepzelca (lurbinectedin) in combination with atezolizumab approved by the European Commission as first-line maintenance therapy for extensive-stage small cell lung cancer
1 June 2026 - Immedica today announces that the European Commission has granted marketing authorisation for Zepzelca (lurbinectedin), in combination with ...
Posted by Michael Wonder on 02 Jun 2026
Loargys (pegzilarginase for injection) approved in Canada for the treatment of arginase 1 deficiency
1 June 2026 - Immedica announces that Health Canada has granted a Notice of Compliance on 29 May 2026 for Loargys ...
Posted by Michael Wonder on 02 Jun 2026
Vertex announces US FDA acceptance of biologics license application for accelerated approval of povetacicept in IgA nephropathy
1 June 2026 - 2026-- Vertex Pharmaceuticals today announced the US FDA has accepted its biologics license application submission for ...
Posted by Michael Wonder on 02 Jun 2026
Zenas BioPharma announces submission of biologics license application to US FDA for obexelimab in IgG4-RD
28 May 2026 - BLA submission based on positive results from Phase 3 INDIGO trial. ...
Posted by Michael Wonder on 02 Jun 2026
US FDA accepts for priority review Bristol Myers Squibb’s supplemental new drug application for Camzyos (mavacamten) to treat adolescents with symptomatic obstructive hypertrophic Cardiomyopathy
1 June 2026 - Bristol Myers Squibb today announced the US FDA accepted a supplemental new drug application for Camzyos ...
Posted by Michael Wonder on 02 Jun 2026
PolyPid completes new drug application submission to FDA for D-PLEX₁₀₀
1 June 2026 - PolyPid today announced the successful completion of its new drug application submission on a rolling review basis ...
Posted by Michael Wonder on 01 Jun 2026
Bristol Myers Squibb announces Opdivo (nivolumab) in combination with AVD receives expanded EU label with approval in frontline advanced classical Hodgkin lymphoma
1 June 2026 - Bristol Myers Squibb today announced that the European Commission has approved Opdivo (nivolumab) in combination with ...
Posted by Michael Wonder on 01 Jun 2026
Rilzabrutinib authorised to treat adults with immune thrombocytopenia when prior treatments have been insufficient
29 May 2026 - The MHRA has today granted a marketing authorisation for the medicines rilzabrutinib (Wayrilz) to treat adults with ...
Posted by Michael Wonder on 01 Jun 2026
Shionogi announces FDA approval of Xocova (ensitrelvir), the first and only oral option to help prevent COVID-19 following exposure
1 June 2026 - Approval is based on SCORPIO-PEP, the only Phase 3 study of an oral antiviral to meet the ...
Posted by Michael Wonder on 01 Jun 2026
AbbVie announces European Commission authorisation of expanded label for Venclyxto (venetoclax) to include additional combinations in previously untreated chronic lymphocytic leukaemia
29 May 2026 - AbbVie today announced that the European Commission (EC) has authorised an expanded label for Vencylxto (venetoclax) to ...
Posted by Michael Wonder on 31 May 2026
MannKind announces FDA approval of Afrezza, the first and only inhaled mealtime insulin for use in children and adolescents aged 6 and older living with diabetes
29 May 2026 - Eligible patients can access Afrezza today for $35 or less per month, with dedicated support through MannKind ...
Posted by Michael Wonder on 29 May 2026
Zydus Therapeutics new drug application for saroglitazar to treat primary biliary cholangitis granted priority review by the US FDA
28 May 2026 - Zydus Therapeutics today announced that the US FDA granted priority review to the new drug application ...
Posted by Michael Wonder on 29 May 2026
Sanofi’s venglustat accepted for priority review in the US to treat type 3 Gaucher disease
28 May 2026 - The US FDA has granted priority review to the new drug application for venglustat, a novel, ...