Provider: Wright Reports
Algeta ASA: Business description, financial summary, 3yr and interim financials, key statistics/ratios and historical ratio analysis.
Provider: Reuters Investment Profile
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Algeta ASA Announces US Nuclear Regulatory Commission's Licensing Decision for Radium-223 Dichloride
Algeta ASA announced that the US (United States) Nuclear Regulatory Commission (NRC) has issued a licensing decision on the medical use of radium-223 dichloride (radium-223). The NRC licensing decision follows the recommendation from the Advisory Committee on the Medical Use of Isotopes (ACMUI) report, dated November 20, 2012. Radium-223 is an investigational agent and is not approved by the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) or other health authorities. The US NRC has ruled that sites can procure and administer radium-223 under 10 CFR Part 35, Subpart E, which includes 10 CFR § 35.300. It has also ruled that physicians authorized under 10 CFR § 35.390 or 10 CFR § 35.396 can be authorized for the medical use of radium-223. The US NRC has notified the Agreement States regarding their licensing decision on radium-223.
Latest Developments for Algeta ASA
- Algeta ASA confirms that it is in receipt of preliminary acquisition proposal from Bayer AG
- Algeta ASA's Partner Bayer Receives Marketing Authorisation from European Commission for Xofigo
- EMA Recommends Algeta ASA's Radium Ra 223 Dichloride Developed in Cooperation with Bayer for Approval
- United States FDA Approves Algeta ASA's Xofigo
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