BioSpace News Archive

FDA

Myovant Sciences Announces FDA Approval of ORGOVYX™ (relugolix), the First and Only Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer

ORGOVYX demonstrated a 96.7% response rate in testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks in the Phase 3 HERO study

December 18, 2020
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11 min read
Policy

FibroGen Provides Regulatory Update on Roxadustat

FibroGen, Inc. announced that the U.S. Food and Drug Administration has extended the review period of the New Drug Application for roxadustat for the treatment of anemia of chronic kidney disease by three months.

December 18, 2020
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5 min read
Policy

FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts

December 18, 2020
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7 min read
BioCapital

APhA Statement Following Emergency Use Authorization of the Moderna COVID-19 Vaccine

Statement from Scott J. Knoer, MS, PharmD, FASHP, executive vice president and CEO of the American Pharmacists Association, upon the Food and Drug Administration’s decision to authorize emergency use of Moderna’s COVID-19 vaccine

December 18, 2020
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1 min read
FDA

Moderna Announces FDA Authorization of Moderna COVID-19 Vaccine in U.S.

Total of 200 million doses ordered by the U.S government to date; U.S. government retains option to purchase up to an additional 300 million doses

December 18, 2020
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14 min read
Policy

Statement on the U.S. authorization of the Moderna COVID-19 vaccine

Health Canada is aware that the U.S. Food and Drug Administration has issued an emergency use authorization for a COVID-19 vaccine manufactured by Moderna.

December 18, 2020
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1 min read