The company expects to begin shipping this product before the end of its fiscal first quarter, ending December 31, 2021
Cortrophin gel is purified corticotropin (ACTH), an important treatment option for patients struggling with certain chronic autoimmune disorders. It acquired the NDA for cortrophin gel from Merck & Co. in 2016
It provides an option to automatically perform nodule detection immediately after chest X-ray imaging
Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications
The Phase 3 study is designed to bridge data collected from the vaccine efficacy trial conducted in India to the U.S. population
Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial, supporting potential as a best-in-class option
The authority also allowed mix and match of booster doses once the primary vaccine has been administered.
Second interchangeable biosimilar product approved by agency
The Amplitude Solution gives laboratories the ability to scale Covid-19 PCR testing and process up to 8,000 samples a day
The company is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg
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