Regulatory

Successful review of HEMOBLAST Bellows’ performance and safety profile as well as Biom’up’s Quality Management System by the Australian Therapeutic Goods Administration (TGA)
Heidelberg Pharma AG announced that it has adjusted its guidance for the current fiscal year published in March 2019.
CELLINK is receiving a patent from the U.S. Patent and Trademark Office for the design of the company’s flagship bioprinter.
Amryt, a biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases, announces interim results for the six months ended 30 June 2019.
Synairgen plc, the respiratory drug discovery and development company, announces its unaudited interim results for the six months ended 30 June 2019.
International precision medicine firm Lucence Diagnostics announced that it has received the Clinical Laboratory Improvement Amendments certification for its laboratory in Singapore from the U.S. Department of Health and Human Services’ Centers for Medicare & Medicaid Services.
Cygnus Technologies, a Maravai LifeSciences company, announced that it has achieved ISO 9001:2015 certification.
This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.
KnipBio announced that its patent titled Methylotrophs for Aquaculture and Animal Feed has been approved for grant by the European Patent Office.
FDA
Bavarian Nordic A/S announced that the U.S. Food and Drug Administration has approved JYNNEOS™ for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.
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