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RSS FeedPosted 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 10 Jun 2026
RedHill's opaganib receives FDA rare paediatric disease designation for neuroblastoma in addition to current orphan drug designation
9 June 2026 - RedHill Biopharma today announced that the US FDA has granted rare pediatric disease designation to opaganib for ...
Posted by Michael Wonder on 10 Jun 2026
Matisse Pharmaceuticals receives FDA fast track designation for isupartob sodium in sepsis
9 June 2026 - Matisse Pharmaceuticals today announced that the US FDA has granted fast track designation for its lead compound ...
Posted by Michael Wonder on 10 Jun 2026
Imugene's azer-cel granted FDA fast track designation for CLL/SLL and MZL
9 June 2026 - Imugene is pleased to announce that the US FDA has granted fast track designation to azer-cel ...
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 ...