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)
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
Tecentriq is the first and only cancer immunotherapy approved for NSCLC in the adjuvant setting
U.S. FDA to decide whether to authorize a booster dose in the coming days
The BiCNU brand and generic market had U.S. sales of approximately US $ 19.4 million MAT for the most recent twelve months ending in August 2021, according to IQVIA Health
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