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Akebia Therapeutics has submitted a Formal Dispute Resolution Request with the FDA regarding the rejection of vadadustat in anemia due to chronic kidney disease.

Reports of heavy periods – bleeding characterized by increased volume and/or duration that interferes with the quality of life – have been observed during clinical trials, from cases in the real world and in medical literature, according to the European Medicines Agency.

Advisers to the European Medicines Agency have recommended the use of a tetravalent dengue vaccine by the German unit of Japan’s Takeda Pharmaceutical Co Ltd for people aged four years and above.

Europe’s medicines regulator has backed using AstraZeneca’s preventative COVID-19 therapy as a treatment for the disease and also endorsed another medicine as preventative option for another common virus.

The European Medicines Agency (EMA) is recommending Novavax’s COVID-19 vaccine carry a warning of the possibility of two types of heart inflammation, an added burden for a shot that has so far failed to win wide uptake.

The approval comes just one day after the World Health Organization issued a high-level alert declaring the rapidly spreading monkeypox outbreak as a global health emergency.

The European Medicines Agency (EMA) is open to using next generation COVID-19 vaccines that target older offshoots of the Omicron variant this fall, an official said on Thursday, amid a rise in cases due to new Omicron subvariants.

The European Union’s drug regulator said on Tuesday it has started a review to extend the use of Bavarian Nordic’s (BAVA.CO) smallpox vaccine to prevent monkeypox disease as well.

Vertex Pharmaceuticals announced on Wednesday that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to the company’s candidate, inaxaplin (VX-147). Inaxaplin was granted the designation for the treatment of APOL1-mediated focal segment glomerulosclerosis (FSGS).

The U.S. Food and Drug Administration (FDA) approved Dupixent (dupilumab) for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.