FDA Approves Regeneron’s Pasatru for Fibrodysplasia Ossificans Progressiva, Expanding Treatment Options

As reported on BioSpace, the U.S. Food and Drug Administration has approved Regeneron’s Pasatru (garetosmab) for adults with fibrodysplasia ossificans progressiva (FOP), a rare genetic disorder that causes bone to…

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TransThera Secures China’s First Approval for Patients With FGFR Inhibitor-Resistant Cholangiocarcinoma

As reported by allsci, China’s National Medical Products Administration (NMPA) has granted conditional approval to TransThera Sciences’ Yochanra (tinengotinib) for adults with unresectable, advanced, or metastatic cholangiocarcinoma (CCA) carrying FGFR2…

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Zydus Introduces India’s First Once-Daily Nebulized LAMA for COPD Maintenance

As reported by PharmaBiz, Zydus Lifesciences has announced the launch of Revahale (revefenacin), a once-daily nebulized long-acting muscarinic antagonist (LAMA) for the maintenance treatment of chronic obstructive pulmonary disease (COPD).…

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AstraZeneca Ends Phase 3 Volrustomig Study in Lung Cancer After Interim Review Signals Low Likelihood of Success

As reported on BioSpace, AstraZeneca has discontinued a pivotal Phase 3 trial evaluating its investigational bispecific antibody volrustomig in advanced non-small cell lung cancer (NSCLC) after an interim analysis indicated…

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Tirzepatide May Enhance Biologic Therapy Outcomes in Psoriatic Arthritis Patients With Obesity

New observational research suggests that addressing obesity alongside inflammatory joint disease could improve treatment outcomes for people with psoriatic arthritis (PsA). As reported on MedIndia, a recent propensity score-matched analysis…

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Impending PPAR-Targeted Therapies Expand Treatment Possibilities for Primary Biliary Cholangitis

As reported on News Medical, researchers are highlighting a new class of therapies that could improve outcomes for people living with primary biliary cholangitis (PBC), a chronic autoimmune liver disease…

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LEVI-04 Shows Promise as a Novel Non-Opioid Therapy for Knee Osteoarthritis in Phase 2 Trial

A recent study shared by The Lancet shows that a first-in-class investigational therapy targeting neurotrophin-3 (NT-3) significantly reduced pain and improved function in patients with knee osteoarthritis (OA), according to…

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Otsuka Reports Two-Year Kidney Function Benefit With Sibeprenlimab in Phase 3 IgA Nephropathy Trial

Sibeprenlimab-szsi (VOYXACT) slowed estimated glomerular filtration rate decline versus placebo over 24 months in adult patients with primary IgA nephropathy, according to Phase 3 VISIONARY results announced by Otsuka. Otsuka…

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Silence Therapeutics Advances Divesiran After Positive Phase 2 Results in Polycythemia Vera

As reported on Fierce Biotech, Silence Therapeutics reported positive phase 2 findings for divesiran, an investigational small interfering RNA (siRNA) treatment for polycythemia vera (PV), a rare blood cancer marked…

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Belimumab Dose Spacing May Be an Option for Selected Patients With SLE in Sustained Remission

As reported on MedScape, gradually extending the interval between belimumab doses may allow carefully selected patients with systemic lupus erythematosus (SLE) in long-term remission to reduce treatment exposure (and in…

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FDA Grants Breakthrough Therapy Designation to Pemafibrate for Primary Biliary Cholangitis

As reported on PR Newswire, the US Food and Drug Administration has granted Breakthrough Therapy designation to Kowa’s investigational therapy K-808 (pemafibrate) for primary biliary cholangitis (PBC), the company announced.…

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Enfortumab Vedotin/Pembrolizumab Regimen Outperforms Neoadjuvant Chemotherapy in Resectable MIBC

As reported on The ASCO Post, perioperative treatment with enfortumab vedotin-ejfv plus pembrolizumab resulted in superior event-free survival, overall survival, and pathologic response rates compared with neoadjuvant cisplatin/gemcitabine in cisplatin-eligible…

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Axsome Launches Phase 3 CLARITY Study of Solriamfetol for Depression Patients Experiencing Daytime Sleepiness

As reported by The Manila Times, Axsome Therapeutics has announced the initiation of its Phase 3 CLARITY clinical trial evaluating solriamfetol as a potential treatment for adults with major depressive…

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Lilly’s Retatrutide Achieves Strong Weight Loss and Glycemic Benefits in Two Phase 3 Obesity Studies

As reported on Drugs, Eli Lilly has reported positive topline findings from two additional Phase 3 trials of retatrutide, its investigational triple hormone receptor agonist designed to target GIP, GLP-1,…

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