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71
65 进行中
药物批准
1
批准总数
监管机构
监管机构数
成立时间
1946
进行中（未招募）
65
91.5%
已完成
1.4%
招募中
5
7.0%
PHILIPPINES
Philippines FDA
- The FDA has approved Grifols' fibrinogen, human-chmt (Fesilty) for treating acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency. - The therapy is manufactured by Biotest AG at their advanced facility in Germany and represents the second global approval following Germany's approval in November. - Fesilty is expected to be available in the US market during the first half of 2026, offering a more targeted treatment option compared to existing therapies. - Clinical studies showed the most common adverse reactions included pain in extremity, back pain, hypersensitivity reactions, and pyrexia in more than 2% of patients.
