Drug Approval | December 29, 2021
U.S. FDA approves Leo Pharma’s Adbry
Adbry is the first biologic launched by LEO Pharma in the United States and is expected to be available in pharmacies by February 2022
Adbry is the first biologic launched by LEO Pharma in the United States and is expected to be available in pharmacies by February 2022
Innovative market development collaboration also signed, expanding the availability of select Novartis oncology products in regions across China currently not covered by Novartis
EMA’s CHMP advice states that Paxlovid can be used for treatment of adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease
The platform’s technology works as a compression algorithm for molecular testing
Gavreto is the first and only precision medicine approved in the EU for first-line treatment of people with RET fusion-positive advanced NSCLC
The submission is based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11
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 company plans to expand its portfolio in regulated markets aggressively
It becomes the first ophthalmology biosimilar to gain FDA approval in the United States
If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC
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