On July 20th, the FDA released draft Guidance regarding its standards on therapeutic equivalence (TE) between both biologic and small molecule (NCE) drugs.

FDA Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will be taking to ensure that the Orange Book (FDA’s publication of Approved Drug Products with Therapeutic Equivalence ...

Madrigal Pharmaceuticals shares rose after the biopharmaceutical company received a U.S. patent for its Rezdiffra treatment. Shares were up 11% at $345.24 Wednesday. The stock has been up 12.8% this ...

The Approved Drug Products with Therapeutic Equivalence Evaluations is the published list of FDA-approved drugs deemed both safe and effective. It is more commonly called the Orange Book, a ...

The Orange Book, formerly known as the Approved Drug Products with Therapeutic Equivalence Evaluations, was first published in 1980. The updated website features a new design with more user ...

The data come from the publicly available US Food and Drug Administration's (FDA's) Approved Drug Products With Therapeutic Equivalence Evaluations, dubbed the "Orange Book," along with Google ...

These improvements result in patents, which may be valid improvements or inappropriately applied to the drug. Either way, these patents are required to be filed in the Approved Drug Products with ...

Drugmakers can avoid rival products, ... for 30 months after listing a branded drug's patents in the "Orange Book," also known as "Approved Drug Products with Therapeutic Equivalence Evaluations." ...

Quince expects that the resulting patent will be listable in the U.S. Food and Drug Administration’s publication Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).

The US Food and Drug Administration (FDA) has now officially changed the way it regulates insulin and other biologics to facilitate approval for biosimilars.. As of March 23, 2020, insulin and ...