Blog
RSS FeedPosted 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 ...
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
Nouscom receives US FDA fast track designation for NOUS-209, a novel immunotherapy for the prevention of Lynch syndrome-associated cancers
1 June 2026 - Nouscom today announced that the US FDA has granted fast track designation to NOUS-209 for the prevention ...
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
Samsung Bioepis launches Opuviz (aflibercept) 40 mg/mL vial across Europe, to treat ophthalmic conditions
29 May 2026 - Samsung Bioepis today announced the launch of Opuviz 40 mg/mL solution for injection in a vial, ...
Posted by Michael Wonder on 01 Jun 2026
New Zealand Pharmaceutical Schedule - 1 June 2026
1 June 2026 - The June 2026 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 01 Jun 2026
BMS Korea expands Pomalyst reimbursement to secpnd-line multiple myeloma treatment
29 May 2026 - Bristol Myers Squibb Korea said its Pomalyst (pomalidomide)-based triple therapy will become reimbursable from 1 June ...
Posted by Michael Wonder on 01 Jun 2026
Expanded listing to save leukaemia patients $35.5 million a year
1 June 2026 - Eligible patients with leukaemia will have access to $25 scripts for two new treatments following their ...