Skip to content Skip to footer
Subscribe Now

NEWS

Astrazeneca & Daiichi Sankyo
Daiichi Sankyo and AstraZeneca Report the EC Approval for Datroway to Treat Metastatic Triple Negative Breast Cancer
Shots: The EC has approved Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy; regulatory review is ongoing in China & Japan, as well as Australia, Canada, Singapore & Switzerland as part of Project Orbis Approval was backed by the global P-III (TROPION-Breast02)…
July 31, 2026
Amgen
CHMP Recommends Expanded EU Indication for Amgen’s Repatha to Reduce First Heart Attack and Stroke Risk In Adults
Shots: Amgen announced that the CHMP issued a positive opinion recommending an expanded indication for Repatha (evolocumab) to reduce cardiovascular risk in adults with established or high risk for atherosclerotic cardiovascular disease by lowering LDL-C levels, alongside correction of other risk factors The recommendation is supported by the P-III (VESALIUS-CV) study involving  ≥12,000 pts., Repatha…
July 31, 2026
Pfizer New
Pfizer Reports Positive P-III Results for LITFULO in Nonsegmental Vitiligo (NSV)
Shots: Pfizer reported positive topline results from the pivotal P-III TRANQUILLO and TRANQUILLO 2 studies evaluating LITFULO (ritlecitinib) in pts. with NSV. Both studies (n=2,174 pts) met their co-primary endpoints, demonstrating statistically significant improvements in facial and total body repigmentation vs. PBO at 52 wks. across 271 sites globally TRANQUILLO (n=607, ≥12yrs.) evaluated 50mg LITFULO and TRANQUILLO…
July 31, 2026
NIPRO Receives FDA 510(k) Clearance for ELISIO-HX Dialyzer for Expanded Hemodialysis in the US
Shots: NIPRO CORPORATION received US FDA 510(k) clearance for its ELISIO-HX dialyzer, enabling the US commercialization of HDs (Hemodialysis powered by super high-flux membrane). The clearance became effective on July 28, 2026 ELISIO-HX features NIPRO’s proprietary super high-flux membrane technology, designed to enhance the removal of larger middle-molecule uremic toxins while maintaining albumin retention. The…
July 31, 2026
Cytokinetics Reports MHRA Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)
Shots: The MHRA has approved Cytokinetics’ Myqorzo (aficamten) for the treatment of adults with symptomatic (NYHA, class II-III) oHCM MHRA assessment was based on P-III (SEQUOIA-HCM) trial of Myqorzo (n=282), showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen uptake by 1.8 vs 0 ml/kg/min Additionally, NICE has recommended aficamten for eligible…
July 30, 2026
Relation and GSK Partner to Advance Drug Discovery
Shots: Relation has entered a strategic research collaboration with GSK to generate large-scale human cellular perturbation datasets to understand disease biology & discover novel therapeutic targets Relation will generate large-scale perturbation datasets using advanced human cellular disease models & experimental systems to develop, validate, & train foundation models, incl. MORGAN, to investigate disease biology &…
July 30, 2026
Nippon Shinyaku Exercises US Option for AB2 Bio’s Tadekinig Alfa
Shots: Nippon has exercised its exclusive US commercialization option for tadekinig alfa in Primary Monogenic IL-18-Driven Hyperinflammatory Syndrome with NLRC4 & XIAP mutations, with AB2 Bio retaining US rights to all other indications & all rights outside the US AB2 Bio received a $6M option fee in 2025 & will now receive a $30M option…
July 30, 2026
Load more