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The EC has approved Tryngolza (olezarsen) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome
Approval was based on P-III (Balance)…
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The CHMP has recommended AVT03, a biosimilar version of Amgen’s Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disorders
STADA & Dr. Reddy’s have semi-exclusive commercial rights…
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The CHMP has recommended elinzanetant for treating mod. to sev. vasomotor symptoms linked with menopause or caused by AET related to breast cancer based on P-III (OASIS-1, 2, 3…
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Pfizer has entered into a definitive agreement to acquire Metsera, expanding to obesity & cardiometabolic market
As per the deal, Metsera will receive $47.5/share, representing an enterprise value of…
Digital transformation of the pharmaceutical industry is moving beyond buzzwords to real-world impact. At the Pharmaceutical Automation & Digitalisation Congress AUTOMA+ 2025 (24-25 November, Vösendorf, Austria), pharma leaders, including ZETA…
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ACC therapies introduce a novel treatment approach by modulating local pH, promoting bone remodeling, and reducing inflammation, with potential applications in osteoarthritis, calcium deficiencies, late-stage cancers, and bone disorders. …
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The US FDA has approved Keytruda Qlex (pembrolizumab & berahyaluronidase alfa-pmph) for subcutaneous dosing in adults across 38 approved indications of Keytruda, with US availability expected by late Sep 2025
Approval…
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The P-III (evERA Breast Cancer) trial evaluated giredestrant + everolimus vs SoC ET + everolimus in ER+, HER2-, LA/M breast cancer pts previously treated with CDK4/6 inhibitors & endocrine…
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The CHMP has recommended Enflonsia to prevent RSV lower respiratory tract disease in newborns & infants entering their first RSV season, with potential approval valid in all 30 EEA…