Drug Approval | November 01, 2021
Sun Pharma's Winlevi available in the US
It is the first U.S. FDA approved novel topical mechanism for acne in nearly 40 years
It is the first U.S. FDA approved novel topical mechanism for acne in nearly 40 years
The Phase 3 study is designed to bridge data collected from the vaccine efficacy trial conducted in India to the U.S. population
Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications
The implant is surgically inserted into the eye during a one-time, outpatient procedure and refilled every six months
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
Incidences of Non-alcoholic Fatty Liver Disease (NAFLD) have been rising exponentially worldwide and are associated with co-morbidities including obesity, diabetes, hypertension and metabolic disorders
Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD
The test combines sensitivity with speed and is designed to be used in health care settings to aid with rapid diagnosis of Covid-19
The authority also allowed mix and match of booster doses once the primary vaccine has been administered.
Express Scripts, a leading pharmacy benefit management organization, will list Viatris labelled biosimilar insulin Glargine as a preferred insulin brand on its National Preferred Formulary (NPF)
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