The FDA has introduced a pilot fast-track review programme aimed at accelerating reviews for generic medicines tested and manufactured within...
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Eli Lilly and Company has received U.S. Food and Drug Administration (FDA) approval for Inluriyo (imlunestrant, 200 mg tablets), an...
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The U.S. Food and Drug Administration (FDA) has started the process to approve leucovorin calcium tablets as a treatment for...
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The U.S. Food and Drug Administration has granted approval to Incyte’s eczema cream, Opzelura, for use in children aged 2...
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Amneal Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted approval for the company’s sodium...
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The U.S. Food and Drug Administration has granted approval to Johnson & Johnson’s drug delivery system for a specific type...
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The US Food and Drug Administration (FDA) has expanded the indication for recombinant von Willebrand factor (VWF), marketed as Vonvendi,...
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Eisai has achieved an important regulatory milestone as the FDA approves Leqembi IQLIK, strengthening the company’s long-term plans to expand...
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The US FDA approves Sanofi’s Wayrilz (rilzabrutinib) for use in adult patients with chronic or persistent immune thrombocytopenia (ITP) who...
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Ionis Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted approval for DAWNZERA™ (donidalorsen). The treatment is...
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