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Merck
NEWS

The US FDA Expands Merck’s Capvaxive Use to Children and Adolescents Aged 2-17 at Increased Risk for Pneumococcal Disease

Shots: The US FDA has expanded the indication for Capvaxive to incl. pts aged 2–17yrs. with certain chronic medical conditions who have completed a primary pediatric pneumococcal vaccination series & remain at increased risk of pneumococcal disease Approval was supported by P-III (STRIDE-13) trial data, which compared Capvaxive with PPSV23 in the above-mentioned pts Capvaxive…
June 19, 2026

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NEWS

GSK & Spero Therapeutics Report the US FDA Approval of Utebzi for Complicated Urinary Tract Infections (cUTIs)

Shots: The US FDA has approved Utebzi (tebipenem pivoxil; 600mg, PO, Q6H) for the treatment of cUTIs incl. pyelonephritis, in adults who have limited or no alternative oral treatment options, with launch expected by the end of 2026 Approval was supported by the P-III (PIVOT-PO) trial demonstrating that Utebzi was non-inferior to IV imipenem-cilastatin in…
June 18, 2026

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NEWS

CinnaGen Reports the EC Approval of Zandoriah (Biosimilar, Forsteo)

Shots: The EC has granted centralized marketing authorization to Zandoriah, a biosimilar version of Forsteo (teriparatide) for the treatment of osteoporosis in adults, across all 30 EEA states Zandoriah has demonstrated biosimilarity in line with EMA guidelines, with comprehensive comparability studies confirming similar quality, safety, and efficacy to the reference product Teriparatide is a synthetic…
June 16, 2026

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Elanco
NEWS

Elanco Receives the USDA Approval for TruCan Ultra Lyme-L4 Combination Vaccine to Protect Dogs Against Lyme and Leptospirosis

Shots: The USDA has approved Elanco's TruCan Ultra Lyme-L4 to protect dogs against both Lyme disease and leptospirosis, expanding its extensive TruCan Ultra Portfolio TruCan Ultra Lyme-L4 uses Elanco’s PureFil Tech to reduce vaccination reactions & is available in a 1/2mL formulation that delivers the same broad protection as the 1 mL version, enabling comprehensive…
June 16, 2026

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Merck new
NEWS

Merck Reports FDA Approval of Keytruda/Keytruda QLEX + Welireg in Clear Cell Renal Cell Carcinoma

Shots: The US FDA has approved MSD's Welireg + Keytruda/Keytruda QLEX as adj. therapy in clear cell renal cell carcinoma (ccRCC) pts at intermediate-high or high risk of recurrencepost-nephrectomy or post-nephrectomy & resection of metastatic lesions Approval was backed by the P-III (LITESPARK-022) trial data assessing Keytruda (400mg, Q6W, IV) + Welireg (120mg, QD, PO)…
June 15, 2026

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Astrazeneca
NEWS

AstraZeneca’s Truqap Combination Receives the US FDA Approval for PTEN-Deficient mAPMN/S Prostate Cancer

Shots: FDA has approved AZ's Truqap + abiraterone & ADT, along with its companion diagnostic test for adults with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer; regulatory review is ongoing in the EU Approval was based on the global P-III (CAPItello-281) trial assessing Truqap + abiraterone & ADT vs PBO + abiraterone…
June 15, 2026

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