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© 2022 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2022 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
January 19, 2022
The agency discusses its response to COVID-19 and other milestones in its year-end review.
The agency’s COVID-19 task force says latest data shows use of COVID-19 mRNA vaccines during pregnancy is safe.
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 10, 2022
FDA granted Oncoloze’s OM-301 an orphan drug designation for the treatment of acute myeloid leukemia (AML).
January 07, 2022
FDA amended it’s Emergency Use Authorization to shorten Moderna’s vaccine booster dose interval from six to five months.
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.
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.