Regulatory News
Latest Regulatory stories, reviewed before publishing.
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AMA and EMA issue joint guidance on Ebola vaccine development
EMA’s Emergency Task Force (ETF) and the African Medicines Agency (AMA) have published a joint position paper to support the timely start of clinical trials for potential…
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Showing 1–5 of 5 stories
FDA Approves First-of-Its-Kind Chronic Hepatitis B Treatment
FDA today approved Hibsago (bepirovirsen) injection, in combination with existing antiviral therapy, to treat chronic hepatitis B virus (HBV)…
FDA Approves Once-Weekly Generic Hormone Therapy Patch for Women
Today, the U.S. Food and Drug Administration approved the first generic of Climara Pro (estradiol and levonorgestrel transdermal system, 0.045 mg…
FDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and…
The U.S. Food and Drug Administration today granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab-gxly) that may…
FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer
FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer
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