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NEWS

Corcept Therapeutics Reports the US FDA’s NDA Acceptance of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

Shots: The US FDA has accepted NDA of relacorilant for the treatment of Pt-resistant ovarian cancer (PDUFA: Jul 11, 2026) NDA was supported by P-III (ROSELLA) & P-II trials, where relacorilant + nab-paclitaxel demonstrated improved PFS & OS compared to nab-paclitaxel monotx., with no need for biomarker selection & favorable safety Additionally, relacorilant (GR antagonist)…
September 11, 2025

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Fangzhou Joins Forces with Innovent Biologics for AI-Driven Metabolic & Weight Management Solutions

Shots: Fangzhou has partnered with Innovent Biologics to combine digital health services with novel therapies in metabolic diseases & weight management Collaboration will integrate Fangzhou’s AI-driven H2H healthcare ecosystem with Innovent’s pipeline, incl. Mazdutide, & leverage Fangzhou’s XS Core AI large language model powering 5 AI tools: AI Medication Finder, AI Health Manager, AI Doctor…
September 10, 2025

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The US FDA Approves Johnson & Johnson’s Inlexzo for BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)

Shots: The US FDA has approved Inlexzo for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive HR-NMIBC with CIS &/or papillary tumors Approval was based on the P-IIb (SunRISe-1) trial, assessing Inlexzo in pts ineligible or opting out of radical cystectomy, which showed an 82% CR rate, with 51% remaining cancer-free for at least 1yr. post-response Inlexzo is…
September 10, 2025

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Medison and Ipsen’s Bylvay Receives the Health Canada’s Approval to Treat Cholestatic Pruritus in Alagille Syndrome Patients

Shots: Health Canada has approved Bylvay (odevixibat) for the treatment of cholestatic pruritus in pts (≥12mos.) with Alagille Syndrome (ALGS) Approval was based on P-III (ASSERT) trial assessing Bylvay (120µg/kg, QD) vs PBO in ALGS pts for 24wks. across North America, EU, Middle East, & Asia Pacific regions Trial met its 1EP of improved pruritus…
September 10, 2025

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Remedium Bio Joins Forces with Eli Lilly to Advance Gene Therapies for Obesity and Type 2 Diabetes

Shots: Remedium Bio has entered into a multi-target research & development collaboration with Eli Lilly to develop gene therapies targeting multiple targets for the treatment of Obesity & Type 2 Diabetes, leveraging Remedium’s Prometheus platform As per the deal, Remedium will receive an upfront, equity investment as well as development & commercial milestone payments, with tiered…
September 9, 2025

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Varian’s Embozene Receives the European CE Mark Approval for Use in Genicular Artery Embolisation to Treat Knee Osteoarthritis

Shots: Varian has reported the European CE Mark approval of Embozene microspheres for genicular artery embolisation (GAE) to treat knee osteoarthritis Additionally, a Varian-sponsored GENESIS II trial, assessing GAE vs sham treatment for knee osteoarthritis, has completed patient enrollment in the UK GAE aims to reduce knee pain by advancing a small catheter into the…
September 9, 2025

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