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Epygenix Therapeutics Announces FDA Acceptance of IND to Initiate a Clinical Trial of EPX-100 to…

Aug 30, 2021
Epygenix Therapeutics, Inc., a clinical stage biopharmaceutical company focused on rare and intractable genetic epilepsy, announced today that the U.S. Food and Drug Administration…
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UCB Announces BRIVIACT (brivaracetam) CV Now FDA-Approved to Treat Partial-Onset Seizures in…

Aug 30, 2021
UCB announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for BRIVIACT (brivaracetam) CV tablets, oral solution, and injection to treat…
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Roche provides update on Tecentriq US indication for PD-L1-positive, metastatic triple-negative…

Aug 30, 2021
Roche announced that the company has made the decision to voluntarily withdraw the US accelerated approval for Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane,…
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Novartis sabatolimab receives orphan drug designation from the European Commission for…

Aug 30, 2021
Novartis announced that the European Commission (EC) has granted orphan drug designation to sabatolimab (MBG453) for the treatment of myelodysplastic syndromes (MDS), based on clinical…
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Novartis Leqvio (inclisiran) analyses show effective and sustained LDL-C reduction in two…

Aug 30, 2021
Novartis  announced results from two pooled post hoc analyses of Phase III ORION-9, -10 and -11 trials that showed twice-yearly Leqvio (inclisiran) provided effective and sustained…
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European Commission Approves BioMarin’s VOXZOGO (vosoritide) for the Treatment of Children…

Aug 30, 2021
BioMarin Pharmaceutical Inc. announced that the European Commission (EC) has granted marketing authorization for VOXZOGO (vosoritide), a once daily injection to treat achondroplasia in…
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Forxiga approved in Japan for the treatment of chronic kidney disease in patients with and without…

Aug 26, 2021
AstraZeneca’s Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in Japan for the treatment of chronic kidney disease (CKD) in adults with…
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INOVIO Receives Authorization to Conduct Phase 3 Efficacy Trial of its COVID-19 DNA Vaccine…

Aug 26, 2021
INOVIO a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases,…
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FDA Clears Thermo Scientific EliA SmD(P)-S Test For Use In U.S.

Aug 26, 2021
Thermo Scientific EliA SmDP-S test has been cleared by the U.S. Food & Drug Administration (FDA) for aiding the diagnosis of Systemic Lupus Erythematosus (SLE), the most common type…
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Ironwood Pharmaceuticals Announces FDA Approval of Revised LINZESS (linaclotide) Label

Aug 26, 2021
Ironwood Pharmaceuticals, Inc. a GI-focused healthcare company, announced that the U.S. Food and Drug Administration (FDA) approved a revised label for LINZESS (linaclotide) based on…
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