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January 21, 2022
AstraZeneca's Tagrisso has been accepted for use as a monotherapy for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations in Scotland.
January 14, 2022
According to the company, Lumykras (Sotorasib) is the first targeted therapy approved in the European Union for patients with the KRAS G12C mutation.
The UK’s National Institute of Health and Care Excellence has recommended the use of Janssen’s Darzalex (daratumumab) in combination with Velcade (bortezomib), thalidomide and dexamethasone (DVTd) to treat adults with multiple myeloma.
January 12, 2022
The Centers for Medicare and Medicaid Services took action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm (aducanumab).
January 07, 2022
FDA has cleared an IND from Poseida Therapeutics, allowing continued development of the company’s allogeneic CAR-T cell therapy candidate for treating multiple solid tumors.
Pharming Group, has been granted a positive opinion by EMA for its Paediatric Investigation Plan for leniolisib.
January 05, 2022
FDA maintained a steady pace in 2021 in approving important new therapies for market, including new vaccines and treatments for COVID-19.
January 03, 2022
The agency is expanding the use of a single booster of the Pfizer-BioNTech vaccine to children ages 12–15 and is shortening the time between primary vaccination and booster to at least five months.
FDA authorized emergency use of Pfizer’s oral antiviral drug to make the drug available as quickly as possible.
Warp speed is amazoning pharma practices and protocols.