transthyretin amyloidosis
Mar 25, 2025
Clover’s SCB-1019 RSV Revaccination Study Clears U.S. IND; FDA Approves AMVUTTRA for ATTR-CM CV Risk Reduction; Pembrolizumab Combo Greenlit for HER2+ Gastric/GEJ Cancer; TREMFYA Becomes First IL-23 Inhibitor Approved for Crohn’s; FDA OKs GOZELLIX for Prostate Cancer Imaging
Clover’s RSV Vaccine Candidate SCB-1019 Gains U.S. IND Clearance for Revaccination Study Clover Biopharmaceuticals, Ltd. has received FDA clearance for its Investigational New Drug (IND) application and has initiated a Phase I revaccination clinical trial for SCB-1019, its non-adjuvanted bivalent RSV prefusion-s...
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Dec 03, 2024
FDA Grants Fast Track for Lin BioScience’s LBS-007; Alnylam’s AMVUTTRA sNDA Under Review; FDA Approves RAPIBLYK for Atrial Fibrillation; Applied Therapeutics Receives CRL for Govorestat in Galactosemia; R289 Gets Fast Track for Lower-Risk MDS.
Lin BioScience Receives FDA Fast Track Designation for LBS-007 Lin BioScience, a clinical-stage biopharmaceutical company focused on developing innovative therapies for acute leukemia, announced that its lead pipeline candidate, LBS-007, has been granted Fast Track Designation by the FDA for the treatment of acu...
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Sep 03, 2024
Bayer Phase III NSCLC Trial; D&D Pharmatech Gets FDA Nod for GLP-1R Agonist in Multiple Scletosis; Merck Halts Two KEYTRUDA Trials; Novartis Expands LEQVIO After Phase III Success; Alnylam Reports Strong Phase III Data for Vutrisiran
Bayer Starts Phase III Trial In Non-Small Cell Lung Cancer (NSCLC) Bayer has officially enrolled the first patient in the global Phase III SOHO-02 trial, which will evaluate the efficacy and safety of BAY 2927088 as a first-line treatment for advanced non-small cell lung cancer (NSCLC) with activating HER2 mutat...
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Oct 09, 2018
Notizia
FDA approves transthyretin amyloidosis therapy of Akcea, Ionis Patients with an orphan, hereditary disease that is transthyretin amyloidosis with a second new treatment option are available after the Food and Drug Administration approved Akcea Therapeutics and Ionis Pharmaceuticals' Tegsedi. As Tegsedi is approved,...
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Aug 29, 2018
Notizia
Novartis sends out orphan disease drug to LifeMax Labs LifeMax Laboratories, biotech based in San Francisco is given an authorization of a treatment by Novartis for Netherton syndrome, an orphan genetic disorder. Focus of treatment is on managing symptoms and avoiding skin infections and other complications. Life...
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