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RSS FeedPosted 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 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
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 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 ...
Posted by Michael Wonder on 03 Jun 2026
Cingulate receives complete response letter from FDA for CTx-1301
2 June 2026 - Cingulate today announced that the US FDA has issued a complete response letter for its new ...
Posted by Michael Wonder on 03 Jun 2026
Agilent receives FDA approval for expanded use of PD-L1 IHC 22C3 pharmDx on Dako Omnis in oesophageal squamous cell carcinoma, triple negative breast cancer, cervical cancer and gastric or gastro-oesophageal junction adenocarcinoma
2 June 2026 - Approval expands PD-L1 testing onto an automated workflow to support treatment decisions with Keytruda (pembrolizumab). ...
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 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 ...