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RSS FeedPosted 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 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
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 10 Jun 2026
EMA confirms asundexian marketing authorization application for assessment in secondary prevention of ischemic stroke
10 June 2026 - Bayer today announced that the EMA has positively validated and begun assessing the company’s marketing authorisation ...
Posted by Michael Wonder on 10 Jun 2026
Nipocalimab (Imaavy) authorised to treat adults and adolescents with generalised myasthenia gravis
9 June 2026 - The MHRA has today authorised the medicine nipocalimab (Imaavy) to treat adults and adolescents aged 12 years ...
Posted by Michael Wonder on 10 Jun 2026
Chiesi Global Rare Diseases announces Health Canada grants priority review for Filsuvez (birch triterpenes) topical gel for the treatment of epidermolysis bullosa
9 June 2026 - Chiesi Global Rare Diseases today announced that Health Canada has accepted the new drug submission for Filzuvez ...
Posted by Michael Wonder on 10 Jun 2026
Nucala (mepolizumab) approved in Canada for use in adults with chronic obstructive pulmonary disease
9 June 2026 - GSK announced today that Health Canada has approved Nucala (mepolizumab) as an add-on maintenance treatment in ...
Posted by Michael Wonder on 10 Jun 2026
FDA approves Lilly's Ebglyss (lebrikizumab-lbkz) for one maintenance dose every eight weeks in patients with moderate to severe atopic dermatitis
9 June 2026 - Eli Lilly announced today that the US FDA approved a regimen of one maintenance dose every eight ...
Posted by Michael Wonder on 09 Jun 2026
US FDA accepts Takeda's application for intravenous Entyvio (vedolizumab) in paediatric ulcerative colitis and Crohn's disease
9 June 2026 - Takeda today announced the US FDA has accepted for review its supplemental biologics license application for intravenous ...
Posted by Michael Wonder on 09 Jun 2026
Health Canada authorizes Lunsumio (mosunetuzumab) for the treatment of relapsed or refractory follicular lymphoma after two or more systemic therapies
8 June 2026 - Roche Canada is pleased to announce that Health Canada has granted market authorisations for Lunsumio (mosunetuzumab ...