Category: Pharma News
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Aphaia’s coated-glucose platform: A new approach to obesity treatment
Harnessing gut physiology, Aphaia Pharma plans to chart a safer, more natural path to lasting weight control.
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Telix starts clinical trial for pain therapy for metastatic bone cancer
Telix Pharmaceuticals doses first patient in its SOLACE trial, testing a non-opioid radiopharmaceutical for advanced cancer pain.
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FDA expands Novo Nordisk’s Rybelsus label to include cardiovascular risk reduction
The FDA has approved a new use for Novo Nordisk’s oral semaglutide, expanding its label to reduce cardiovascular risk in high-risk adults with type 2 diabetes.
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ESMO 2025: Promising Phase II data for Sanofi’s alpha therapy
Investigational targeted alpha therapy AlphaMedix shows clinical activity in patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
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I-Mab to rebrand as NovaBridge Biosciences, pursue Hong Kong IPO
Biotech firm I-Mab unveils global transformation, dual listing plan, and new focus under the NovaBridge Biosciences name.
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Grifols expands US diagnostic manufacturing with new San Diego facility
The company plans to open a high-tech San Diego plant to boost US blood typing production, meeting rising transfusion demand.
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Enterome’s lymphoma drug wins FDA fast track designation
The company is exploring EO2463’s efficacy in relapsed or refractory settings in a Phase I/II trial, with plans to start Phase III registrational trial in a “watch-and-wait” iNHL patient population
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UEGW 2025: AbbVie bolsters IBD data for Rinvoq and Skyrizi
New data and lead investigators also reinforce the importance of treating beyond symptoms in Crohn’s disease and ulcerative colitis.
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FDA grants breakthrough status to Cidara’s flu drug
Cidara Therapeutics’ CD388, a long-acting influenza prophylactic, has previously received funding worth up to $339 million from the US BARDA.
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FDA expands Teva’s Uzedy approval to include bipolar I disorder
Teva’s long-acting subcutaneous formulation of Johnson and Johnson’s (J&J) Risperdal is already approved for schizophrenia.
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Grifols’ Biotest launches Yimmugo immunoglobulin therapy in US market
The US FDA approved the intravenous immunoglobulin (IVIg) therapy for the treatment of primary immunodeficiencies (PID) last year.
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Cidara secures $339m from BARDA for non-vaccine flu therapy
Cidara Therapeutics wins BARDA backing to expand US manufacturing and clinical development of its long-acting, non-vaccine influenza therapeutic, CD388.
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Navigating the Risks and Rewards of Biomarker-Based Surrogates and Accelerated Approval
The risks and rewards of biomarker-based surrogates are crucial for optimizing clinical trial outcomes and guiding effective treatments.
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ASH25: Gallop’s LYT-200 shows unprecedented survival in AML
The company’s execs talk about the striking efficacy and safety signals seen in Phase I data, the science behind the molecule, and their vision for transforming AML therapy.
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Promis reports first human evidence of aβ oligomer reduction by pmn310
PMN310 demonstrates dose-dependent reduction of amyloid-beta oligomers in human CSF, marking a key milestone in Alzheimer’s treatment development.
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Urologic Health secures $11 million for non-invasive bladder monitoring
Urologic Health raises $11million seed funding to advance a catheter-free bladder monitoring platform toward FDA clearance and US market entry.
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Novo Nordisk’s denecimig cuts bleeding in hemophilia A regardless of inhibitors
Phase III trial shows once‑monthly and once‑weekly denecimig (Mim8) significantly reduces annualized bleeding rate versus standard care, with up to 95% of patients bleed‑free.