Briefs: Zydus Lifesciences and Kimia Biosciences

The inspection concluded with four Form 483 observations. None of the observations were related to data integrity.

Zydus Lifesciences receives USFDA approval for Adapalene and Benzoyl Peroxide Topical Gel

The drug will be manufactured at the group’s topical facility at Ahmedabad

Zydus Lifesciences receives final approval from USFDA for Pemetrexed for Injection

Pemetrexed for Injection has a market size of USD 1,236 mn (as per IQVIA MAT March’22)

Zydus Lifesciences receives final approval from USFDA for Cyanocobalamin Injection

The drug will be manufactured at the group's injectables manufacturing facility at Jarod, Gujarat

Zydus Lifesciences subsidiary Sentynl acquires BridgeBio’s Nulibry

Nulibry is approved by the U.S. Food and Drug Administration (USFDA) to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare, life-threatening paediatric genetic disorder

Cadila Healthcare is now Zydus Lifesciences

Zydus unveils its ‘innovation and care’ centric corporate brand identity

Zydus Partners with Bioeq for US commercialisation rights for Nufymco

NUFYMCO BLA has been approved by the USFDA

Zydus signs exclusive agreement with Myriad Genetics of US to launch cancer-risk assessment diagnostic tests in India

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