IQIRVO: A Revolutionary PPAR Agonist Transforms Second-Line Treatment for Primary Biliary Cholangitis

Primary biliary cholangitis (PBC) represents a chronic, progressive autoimmune liver disease characterized by the destruction of small bile ducts, leading to cholestasis and potentially fatal complications. Affecting millions globally with…

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FDA Grants Priority Review to Takeda’s Oveporexton: A Potential Game-Changer for Narcolepsy Type 1 Treatment

Takeda Pharmaceutical has reached a significant milestone in the development of oveporexton (TAK-861), with the US Food and Drug Administration officially accepting and granting Priority Review status to the investigational…

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Dual Targeting Psoriatic Arthritis and Obesity: Taltz–Zepbound Combo Sets New Benchmark in TOGETHER-PsA Trial

A first-of-its-kind Phase 3b study has shown that combining Eli Lilly’s Taltz (ixekizumab) with Zepbound (tirzepatide) delivers superior benefits for adults living with both active psoriatic arthritis (PsA) and obesity…

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Swiss Biotechs Gain Momentum with FDA Fast Track Option for Palmoplantar Pustulosis

A trio of Swiss biotechnology companies is advancing diverse therapeutic pipelines, with recent developments spanning inflammatory skin disease, immune‑mediated hair loss, and hard‑to‑treat cancers. Together, these milestones highlight how distinct…

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FDA Fast-Tracks Vera Therapeutics’ Atacicept as Potential Gamechanger for IgA Nephropathy Treatment

Vera Therapeutics announced a major milestone in drug development on January 7, 2026, when the U.S. Food and Drug Administration granted Priority Review to the Biologics License Application (BLA) for…

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Biohaven’s BHV‑7000 Falls Short in Midstage Depression Trial, Refocusing Pipeline Strategy

As reported on FierceBioTech, Biohaven closed out the holiday period with disappointing news: its investigational Kv7.2/7.3 potassium‑channel modulator, BHV‑7000, did not demonstrate efficacy in a phase 2 clinical trial for…

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Eccogene Launches MOSAIC Trial to Test Dual Mechanisms Against Metabolic Liver Disease

Eccogene, a clinical-stage biopharmaceutical company, has announced enrollment of the first patient in MOSAIC, a Phase 2a clinical trial investigating two novel oral small molecules for treating metabolic dysfunction-associated steatohepatitis…

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Eli Lilly’s Jaypirca Positions Itself as Superior Alternative to Imbruvica in Blood Cancer Treatment

Eli Lilly presented compelling clinical evidence positioning its BTK inhibitor Jaypirca as a potentially superior treatment option compared to the established blood cancer therapy Imbruvica, marking a significant competitive shift…

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FASENRA Demonstrates Breakthrough Results in Rare Eosinophilic Disease: NATRON Trial Shows Promise for Hypereosinophilic Syndrome Patients

Hypereosinophilic syndrome (HES) patients may finally have a meaningful treatment option. According to an article published at BusinessWire.com, AstraZeneca's FASENRA (benralizumab) has shown statistically significant efficacy in delaying disease progression,…

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Sanofi’s Efdoralprin Alfa Shows Promise in Treating Alpha-1 Antitrypsin Deficiency Emphysema

Sanofi has announced encouraging results from its Phase 2 ElevAATe clinical trial evaluating efdoralprin alfa (SAR447537), a recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, for the treatment of emphysema caused…

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Genentech Announces Promising Phase III Results for Vamikibart in Treating Uveitic Macular Edema

Genentech, a member of the Roche Group, has unveiled results from two pivotal Phase III trials—MEERKAT and SANDCAT—evaluating the investigational drug vamikibart for uveitic macular edema (UME), a sight-threatening complication…

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Syndax Pharmaceutical’s Revumenib Meets its Primary Endpoint to Treat Relaxed/Refractory Acute AML

According to a press release from Syndax Pharmaceuticals, the developer of Revumenib, the drug met its primary endpoint resulting in complete remission (CR) or CR with partial recovery.  Relapsed or…

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Promising Advances for Advanced Bladder Cancer: DATROWAY® Plus Rilvegostomig in TROPION-PanTumor03 Trial

Initial results from the TROPION-PanTumor03 phase 2 trial, presented at the 2025 ESMO Congress, show that the combination of DATROWAY® (datopotamab deruxtecan) and rilvegostomig offers significant tumor responses and disease…

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Phase 2 GLEAM Trial of Zolbetuximab in Pancreatic Cancer Falls Short of Primary Endpoint

Astellas Pharma Inc. has announced that its Phase 2 GLEAM trial evaluating zolbetuximab in combination with gemcitabine plus nab-paclitaxel for metastatic pancreatic adenocarcinoma did not meet its primary endpoint of…

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Datroway Shows Survival Benefit in Late-Stage Trial for Triple-Negative Breast Cancer

AstraZeneca and Daiichi Sankyo have announced promising Phase 3 trial results for Datroway, their investigational antibody-drug conjugate (ADC) targeting triple-negative breast cancer (TNBC). The trial demonstrated that Datroway significantly slowed…

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Investigational Cell Therapy Bemdaneprocel Shows Sustained Safety and Promising Motor Improvements at 36 Months in Parkinson’s Disease Trial

Bayer AG and its subsidiary BlueRock Therapeutics LP have announced encouraging 36-month follow-up data from the Phase I exPDite clinical trial of bemdaneprocel (BRT-DA01), an investigational cell therapy aimed at…

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Cogent Biosciences Reports Encouraging Results for BEZUCLASTINIB in Indolent Systemic Mastocytosis

Cogent Biosciences has announced new clinical trial results indicating that its drug BEZUCLASTINIB offers promising benefits for patients with indolent systemic mastocytosis (ISM), a rare and chronic disorder characterized by…

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