PHOENIXVILLE, PA — Facet Life Sciences, a firm specializing in regulatory guidance for life science companies, has announced ...

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 ...

Vadodara: Alembic Pharmaceuticals Limited has announced that the company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) ...

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 ...

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, ...

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 ...

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， ...