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FDA Approval: CAPLYTA to Treat Bipolar I and II Depression

FDA Approval: CAPLYTA to Treat Bipolar I and II Depression

Dec 20, 2021 | FDA, Health, News, Regulatory

Biopharmaceutical company, Intra-Cellular Therapies, has announced U.S. Food and Drug Administration (FDA) approval of CAPLYTA to treat bipolar I and bipolar II disorders. Bipolar is a mental disorder characterized by unusual mood swings, energy levels, and...
NKX101: FDA Orphan Drug Designation for Nkarta’s AML Drug

NKX101: FDA Orphan Drug Designation for Nkarta’s AML Drug

Dec 16, 2021 | Clinical Trials, FDA, News, Regulatory

In a potential development for clinical trial translations to come, the U.S. Food and Drug Administration (FDA) authorized orphan drug designation (ODD) to Nkarta’s engineered natural killer (NK) cell therapy NKX101 for the treatment of acute myeloid leukemia (AML)....
Chemo Side Effects: A Global Challenge for Cancer Treatments

Chemo Side Effects: A Global Challenge for Cancer Treatments

Oct 22, 2021 | FDA, Health, Healthcare, Medical Translation, Pharmaceuticals, Regulatory

Advancements in global medicine and specialist care are essential to improving quality of life, treatment options, and survival rates for those with a cancer diagnosis, as well as mitigating the side effects that come with receiving those treatments. Recently, the US...
Breast Cancer: FDA Approves Eli Lilly Verzenio Inhibitor

Breast Cancer: FDA Approves Eli Lilly Verzenio Inhibitor

Oct 13, 2021 | Health, News, Regulatory

Eli Lilly and Company has received FDA approval from the US FDA (Food and Drug Administration) for the first and only CDK4/6 inhibitor for a specific group of people with Breast Cancer. Verzenio, abemaciclib, aims to treat adult patients with hormone receptor-positive...
FDA Approves ChemoCentryx Drug for Rare Autoimmune Disease

FDA Approves ChemoCentryx Drug for Rare Autoimmune Disease

Oct 8, 2021 | News, Regulatory

ChemoCentryx has received US FDA (Food and Drug Administration) approval for their drug, avacopan, to treat the rare, fatal autoimmune disease, antineutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAV). The oral drug, brand name Tavneos, will help those...
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