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Leads Biolabs Reports NMPA IND Clearnce to Initiate P-Ib/II Trial for Opamtistomig Combination Therapy in mCRC
Shots: The NMPA has approved IND application to initiate P-Ib/II trial of opamtistomig (LBL-024) in combination therapy for metastatic colorectal cancer (mCRC) Trial will evaluate the safety & efficacy of opamtistomig combination regimens in pts with mCRC & explore potential predictive biomarkers. Opamtistomig mechanism was already validated across EP-NEC, NSCLC, SCLC, & biliary tract cancer…
August 3, 2026
Novartis Reports the US FDA Approval of Pluvicto for mHSPC
Shots: The US FDA has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) with an androgen receptor pathway inhibitor (ARPI) for pts with PSMA+ metastatic androgen pathway modulation-naive/sensitive (mAPMN/S) prostate cancer Approval was based on the P-III (PSMAddition) trial, which showed Pluvicto + ARPI & ADT reduced the risk of progression or death by 28% vs SoC…
August 3, 2026
IMPACT Therapeutics Inks Exclusive Licensing Agreement with Pharmanovia for Senaparib in EMEA, Australia and New Zealand
Shots: IMPACT Therapeutics has entered into an exclusive licensing agreement with Pharmanovia for the exclusive rights to manufacture, develop, and commercialise senaparib in EMEA, Australia, and New Zealand As per the deal, Pharmanovia will acquire exclusive rights to manufacture, develop & commercialise senaparib across EMEA, Australia & New Zealand, with IMPACT eligible for upfront, regulatory…
July 31, 2026
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
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