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Sakigake (さきがけ, lit. "pathfinder", "harbinger") is a drug designation by the Pharmaceuticals and Medical Devices Agency, the pharmaceuticals regulator of Japan.It was designed to provide easier access to novel advanced treatments. [1]
The chief executive of the agency is Yasuhiro Fujiwara, former head of the National Cancer Center Japan. From 2008 to 2018, the chief executive of the agency was Tatsuya Kondo, a neurosurgeon and graduate of the University of Tokyo.
The drug, which is already approved in Japan has faced a long path to the U.S. market, with the Food and Drug Administration (FDA) declining to approve it in 2019 in a different set of acute ...
Health supplement products believed to have caused two deaths and sickened more than 100 people have been ordered to be taken off store shelves in Japan. The products from Kobayashi Pharmaceutical ...
Tucidinostat is approved by the Chinese FDA for relapsed or refractory peripheral T-cell lymphoma (PTCL) and has orphan drug status in Japan. [2] [better source needed] In Japan, it was approved for relapsed or refractory adult T-cell leukemia-lymphoma (ATLL) treatment in June 2021. [4]
How Much Does Ozempic Cost? Ozempic Price Breakdown. Ozempic is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to help with blood sugar control in people with ...
Japan: Pharmaceuticals and Medical Devices Agency (PMDA) 2014 Latvia: State Agency of Medicines Zāļu valsts aģentūra (ZVA) 2004 Liechtenstein: Office of Healthcare Amt für Gesundheit (AG) 1995 Lithuania: State Medicines Control Agency (SMCA) 2009 Malaysia: National Pharmaceutical Regulatory Agency (NPRA) Bahagian Regulatori Farmasi Negara ...
EssilorLuxottica said on Monday it received a green light from the U.S. Food and Drug Administration (FDA) for its over-the-counter Nuance audio glasses. Nuance - which pairs hearing solutions ...