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The Health Sciences Authority headquarters at Outram Road, Singapore. HSA was formed on 1 April 2001 with the integration of five specialised agencies under the Ministry of Health: the Centre for Drug Evaluation; Institute of Science and Forensic Medicine; National Pharmaceutical Administration; Product Regulation Department; and Singapore Blood Transfusion Service.
The Health Sciences Authority (HSA) also approved the use of the Pfizer-BioNTech coronavirus vaccine for children aged 12 to 15; previously, it was given only to those aged 16 years and above. It was granted interim authorization by the HSA under the Pandemic Special Access Route in December 2020. [21] [26] [27]
Tucatinib is a kinase inhibitor indicated in combination with trastuzumab and capecitabine for the treatment of adults with advanced unresectable or metastatic HER2-positive breast cancer, including those with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
The Health Sciences Authority (HSA) on Tuesday (8 June) said it had removed over 3,200 listings of illegal health products sold on local e-commerce platforms from January to May.
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
In June 2024, the Food and Drug Administration granted traditional approval to selpercatinib for people aged two years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). The applicant was Eli Lilly and Company.
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Ensitrelvir was approved for emergency use in Japan in November 2022, [8] [3] [4] before gaining full approval in March 2024. [1] It was approved in Singapore in November 2023. [16] In April 2023, ensitrelvir was given a "Fast Track" designation from the US Food and Drug Administration. [17]
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