FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission

If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease

Zydus and Formycon secure US and Canada partnership for Keytruda biosimilar

Formycon AG will develop, register, manufacture and supply the product, while Zydus Lifesciences Global FZE, United Arab Emirates will be responsible for the commercialization of FYB206 in the defined territories

Zydus launches affordable biosimilar 'Zyrifa' for cancer-related bone complications

Zyrifa is indicated for patients with bone metastases stemming from a wide range of solid tumors

Zydus inks licensing, commercialisation pact with RK Pharma

RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA submission and commercialization of the product in the US

Zydus receives FDA’s tentative approval for Empagliflozin and Linagliptin tablets

Zydus receives FDA’s final approval for Verapamil Hydrochloride ER tablets

Zydus receives final approval from USFDA for Leuprolide Acetate injection

Leuprolide Acetate injection is indicated in the palliative treatment of advanced prostatic cancer

Zydus receives FDA final approval for Diroximel fumarate delayed-release capsules, 231 mg

Diroximel fumarate delayed-release capsules, 231 mg, are indicated for the treatment of relapsing forms of multiple sclerosis

Zydus receives China's NMPA approval for Venlafaxine ER capsules, 75 mg and 150 mg

Zydus receives FDA’s ODD for Desidustat for the treatment of beta-thalassemia

Orphan drug designation (ODD) by the USFDA for Desidustat, provides eligibility for a potential seven-year marketing exclusivity subject to the USFDA approval