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RSS FeedPosted by Michael Wonder on 11 Jun 2026
Italfarmaco announces Health Canada acceptance and priority review of new drug submission for givinostat as a Duchenne muscular dystrophy treatment
10 June 2026 - New drug submission is based on Italfarmaco’s Phase 3 EPIDYS trial data demonstrating meaningful treatment benefits ...
Posted by Michael Wonder on 15 Jun 2026
Oncopeptides submits type II variation application to EMA for Pepaxti label expansion into third-line treatment
12 June 2026 - Oncopeptides today announces that it has formally submitted its type II variation application to the EMA. ...
Posted by Michael Wonder on 15 Jun 2026
Belite Bio completes rolling submission of new drug application to US FDA for tinlarebant for the treatment of Stargardt disease type 1
12 June 2026 - Belite Bio today announced the completion of its rolling submission of a new drug application to ...
Posted by Michael Wonder on 15 Jun 2026
US FDA grants orphan drug and rare paediatric disease designations to GEn1E Lifesciences’ dual signal modulator for the treatment of Duchenne muscular dystrophy
9 June 2026 - GEn1E Lifesciences today announced that the US FDA has granted both orphan drug designation and rare paediatric ...
Posted by Michael Wonder on 15 Jun 2026
Ultomiris granted priority review in the US as treatment for adults with immunoglobulin A nephropathy
15 June 2026 - Based on I CAN Phase 3 trial results from prespecified interim analysis in which Ultomiris demonstrated 43.4% ...
Posted by Michael Wonder on 14 Jun 2026
Camurus provides regulatory update on the US NDA for CAM2029 (Oclaiz) in acromegaly
10 June 2026 - Camurus today announced that the US FDA has issued a complete response letter regarding the new ...
Posted by Michael Wonder on 14 Jun 2026
Sanofi’s Tzield approved in the US as the first disease-modifying therapy for patients recently diagnosed with stage 3 type 1 diabetes
12 June 2026 - Approval based on the PROTECT phase 3 study and additional data from the global clinical development program ...
Posted by Michael Wonder on 13 Jun 2026
FDA approves capivasertib with abiraterone and prednisone for PTEN deficient androgen pathway modulation-naïve or -sensitive prostate cancer
12 June 2026 - Today, the FDA approved capivasertib (Truqap, AstraZeneca) in combination with abiraterone and prednisone for adults with ...
Posted by Michael Wonder on 13 Jun 2026
Guardant Health announces FDA approval of Guardant360 CDx as companion diagnostic for Boehringer Ingelheim’s Hernexeos
11 June 2026 - Guardant Health today announced that the US FDA has approved Guardant360 CDx as a companion diagnostic ...
Posted by Michael Wonder on 12 Jun 2026
FDA grants priority review for Genentech’s Tecentriq for a certain type of stage III colon cancer
10 June 2026 - Genentech announced today that the US FDA has accepted the company’s supplemental biologics license application filing for ...
Posted by Michael Wonder on 12 Jun 2026
FDA approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinoma
12 June 2026 - Today, the FDA approved belzutifan (Welireg, Merck) in combination with pembrolizumab (Keytruda, Merck) or pembrolizumab and ...
Posted by Michael Wonder on 12 Jun 2026
Truqap combination approved in the US as first and only targeted treatment for PTEN-deficient metastatic hormone-sensitive prostate cancer
12 June 2026 - Based on results of CAPItello-281 which prospectively defined PTEN deficient disease and showed Truqap combination reduced risk ...
Posted by Michael Wonder on 11 Jun 2026
Eli Lilly Canada welcome Quebec public reimbursement of Verzenio (abemaciclib) for mBC following successful PCPA negotiation
10 June 2026 - Eli Lilly Canada is pleased to announce that Verzenio (abemaciclib) is now publicly reimbursed in Québec ...
Posted by Michael Wonder on 11 Jun 2026
Zemcelpro (UM171 cell therapy) licensing and supply agreements announced for Canada
10 June 2026 - ExCellThera today announced exclusive licensing and supply agreements granting Medexus the Canadian commercialization rights for Zemcelpro ...
Posted by Michael Wonder on 11 Jun 2026
Slow process: 48 treatments awaiting approval in the Netherlands already used in Germany
10 June 2026 - The Netherlands takes much longer than other countries to give patients access to new medicines and ...