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RSS FeedPosted 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 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 ...
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 08 Jun 2026
US FDA approves Pfizer’s Hympavzi for the treatment of two additional haemophilia A or B patient populations with significant medical need
8 June 2026 - Pfizer today announced that the US FDA has approved an expanded indication for Hympavzi (marstacimab-hncq) to include ...
Posted by Michael Wonder on 06 Jun 2026
Xspray Pharma receives CRL from US FDA for Nilopki
4 June 2026 - Xspray Pharma has received a complete response letter from the US FDA for its new drug application ...