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RSS FeedPosted by Michael Wonder on 19 Jun 2026
Recommendations made by the PBAC – May 2026
19 June 2026 - Recommendations made by the PBAC in May 2026 relating to the listing of medicines on the PBS ...
Posted by Michael Wonder on 19 Jun 2026
US FDA approves an additional indication for Capvaxive (pneumococcal 21-valent conjugate vaccine) in children and adolescents aged 2 through 17 at increased risk for pneumococcal disease
18 June 2026 - Merck today announced that the US FDA has approved an expanded indication for Capvaxive (pneumococcal 21-valent conjugate ...
Posted by Michael Wonder on 17 Jun 2026
FDA approves first single dose generic treatment for influenza
17 June 2026 - The US FDA today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment ...
Posted by Michael Wonder on 17 Jun 2026
Utebzi (tebipenem pivoxil) approved in the US for adults with complicated urinary tract infections
17 June 2026 - GSK and Spero Therapeutics today announced that the US FDA has approved Utebzi, an oral antibiotic for ...
Posted by Michael Wonder on 17 Jun 2026
FDA broadens access to over the counter naloxone nasal spray for opioid overdose
16 June 2026 - The US FDA today approved another over the counter intranasal naloxone product, Rextovy, a 4 mg naloxone ...
Posted by Michael Wonder on 17 Jun 2026
Health Canada approves Zepbound as the first ever obstructive sleep apnea medication in Canada for adults living with obesity
16 June 2026 - Eli Lilly Canada announced today that Health Canada has approved Zepbound (tirzepatide injection) for the treatment of ...
Posted by Michael Wonder on 17 Jun 2026
Exdensur (depemokimab injection) approved in Canada for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps
16 June 2026 - GSK announced today that Health Canada has approved Exdensur (depemokimab) for two indications. ...
Posted by Michael Wonder on 16 Jun 2026
Bayer’s Ambelvist (gadoquatrane) receives FDA approval for contrast-enhanced MRI to detect and visualise lesions with abnormal vascularity in the central nervous system and non-CNS body region
15 June 2026 - Approval is supported by data from the Phase 3 QUANTI clinical studies, which demonstrated efficacy at a ...
Posted by Michael Wonder on 16 Jun 2026
Roche receives FDA approval for the first companion diagnostic to assess PTEN protein in people living with prostate cancer
12 June 2026 - Roche announced today that the Ventana PTEN (SP218) RxDx Assay is the first immunohistochemistry companion diagnostic test ...
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 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 ...