Facet Life Sciences specializes in guiding life science companies through the complex journey of drug, biologic, and medical device development and registration with the US FDA. Facet is pleased to ...

The drugs we use as prescribed by doctors represent the product approved by the FDA for a specified medical use under its NDA or BLA. Let’s take a look at some of the technical definitions ...

A recent gem he sent me? A no-knead, crispy, cheesy anda paratha recipe from the Instagram page cookingwithbenazir. And let me tell you - this one's a game-changer. What got me hooked was the ...

WHO为eCTD的全面实施制定了详细的过渡时间表。目前处于第0阶段，即eCTD提交尚不可行，但WHO已明确表示，从2025年起，将进入第1阶段，届时企业可以自愿提交新产品的eCTD格式申请，同时也可以自愿提交预认证后变更申请，将现有的预认证产品文件转 ...

Indoco Remedies rose 1.28% to Rs 245.80 after the company announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug ...

The final approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Amlodipine and Atorvastatin tablets of strengths 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 ...

Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ticagrelor Tablets, ...

5月23日，恒瑞医药正式在香港联合交易所主板挂牌上市，成为今年迄今港股第二大IPO，仅次于宁德时代。此举也标志着这家中国医药行业龙头成功完成“A+H”两地上市布局。从1月6日递表到5月23日挂牌上市，历时仅四个半月。根据周四晚的发售价及配发结果公告， ...

The US Court of Appeals for the Federal Circuit affirmed a district court’s noninfringement determination, finding that the presence of a disclaimed compound in the accused product precluded ...

Ltd. (Otsuka) today announce the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sibeprenlimab, an investigational monoclonal antibody ...