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The agency discusses its response to COVID-19 and other milestones in its year-end review.

FDA Publishes 2021 Year in Review

The agency’s COVID-19 task force says latest data shows use of COVID-19 mRNA vaccines during pregnancy is safe.

COVID-19 Vaccines Safe for Use During Pregnancy, EMA States

According to the company, Lumykras (Sotorasib) is the first targeted therapy approved in the European Union for patients with the KRAS G12C mutation.

European Commission Approves Lumykras (Sotorasib) to Treat KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer

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.

NICE Recommends Darzalex in Combination with Velcade to Treat Multiple Myeloma

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

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).

Medicare Limits Aduhelm Coverage to Patients in Clinical Trials

FDA granted Oncoloze’s OM-301 an orphan drug designation for the treatment of acute myeloid leukemia (AML).

FDA Grants Oncolyze Orphan Drug Designation for Leukemia Treatment

FDA amended it’s Emergency Use Authorization to shorten Moderna’s vaccine  booster dose interval from six to five months.

FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine

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.

FDA Accepts IND for Poseida Therapeutics’ Allogeneic CAR-T Cell Therapy Candidate

FDA maintained a steady pace in 2021 in approving important new therapies for market, including new vaccines and treatments for COVID-19.

FDA Keeps New Drugs Coming

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.  

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