Pharmaceutical Technology

JUNE 16, 2023

In 2021, as part of the same Keynote-811 trial, the US Food and Drug Administration (FDA) granted accelerated approval to Keytruda for treating locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma, in combination with trastuzumab and chemotherapy containing fluoropyrimidin and platinum.

Chemotherapy 52

Chemotherapy Labelling FDA Communication 52

Pharmaceutical Technology

APRIL 20, 2023

The district court had previously blocked Sandoz and Zydus from producing, selling, offering to sell, or importing generic versions of Otezla until February 2028. Since the lawsuit began, the FDA has approved Bristol Myers Squibb’s (BMS) Sotyktu (deucravacitinib), another small molecule for psoriasis treatment.

FDA 52

FDA Communication 52

The Checkup by Singlecare

DECEMBER 12, 2024

manufactures, was approved by the Food and Drug Administration ( FDA ) in August 2015 for hypoactive sexual desire disorder ( HSDD ) in pre-menopausal women. Addyi is currently only available as a brand-name drug , but a generic Addyi may be available after 2028. What is the generic for Addyi ? Is Addyi covered by insurance?

Insurance 52

Insurance Insurance Coverage Documentation FDA 52