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RSS FeedPosted by Michael Wonder on 04 Jun 2026
Verastem Oncology announces US FDA fast track designation for VS-7375, an oral and potential best in class investigational KRAS G12D (ON/OFF) inhibitor for the treatment of KRAS G12D mutated locally advanced or metastatic non-small cell lung cancer
3 June 2026 - Verastem Oncology today announced that the US FDA has granted hast track designation to VS-7375, an oral ...
Posted by Michael Wonder on 03 Jun 2026
Terremoto Biosciences granted FDA fast track designation for TER-2013, an AKT1 selective small molecule inhibitor for breast cancer
3 June 2026 - Terremoto Biosciences today announced that the US FDA granted fast track designation for TER-2013, the Company’s lead ...
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
FDA approves more orphan drugs with specific cancer, paediatric indications over EMA
2 June 2026 - The US FDA is more likely to approve drugs with an orphan designation that were indicated ...
Posted by Michael Wonder on 03 Jun 2026
Global tensions with US President Donald Trump could threaten affordable medicines in Australia
2 June 2026 - Australia’s access to affordable medicines could be under threat from global tensions, with one woman forced to ...
Posted by Michael Wonder on 03 Jun 2026
Cheaper medicines for people fighting leukaemia and migraines
3 June 2026 - The Albanese Government is continuing to deliver cheaper medicines with Australians with types of leukaemia and ...
Posted by Michael Wonder on 03 Jun 2026
TearSolutions receives FDA orphan drug and fast track designations for Lacripep in neurotrophic keratitis
2 June 2026 - TearSolutions today announced receiving FDA orphan drug and fast track designations for Lacripep in neurotrophic keratitis. ...
Posted by Michael Wonder on 02 Jun 2026
FDA grants fast track designation to Merakris’ MTX-001
2 June 2026 - Merakris Therapeutics today announced that the US FDA has granted fast track designation to MTX-001, the Company’s ...
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
GSK secures Omjjara reimbursement in Korea, expanding access for myelofibrosis patients
1 June 2026 - GSK Korea said Monday that its myelofibrosis treatment Omjjara (momelotinib hydrochloride hydrate) has been granted reimbursement ...