When Vera Therapeutics in-licensed atacicept from Merck KGaA about six years ago, patients with IgA nephropathy (IgAN) had no ...
The US Food and Drug Administration (FDA) revised its compliance program guide (CPG) for preapproval inspections (PAIs) for ...
More than 2.5 million eye drops are being recalled due to a "foreign substance," according to the U.S. Food and Drug ...
The US Food and Drug Administration (FDA) revised its compliance program guide (CPG) for preapproval inspections (PAIs) for new drugs. This update emphasizes a risk-based approach to making decisions ...
The FDA is urging parents and caregivers to immediately stop using a Nara Organics-brand formula after several infants contracted botulism.
Over 2.5 million bottles of prednisolone acetate eye drops have been recalled nationwide. The FDA warns that the eye drops were recalled due to the “presence of a foreign substance.” If your ...
The biotechnology company will use the federal pilot program for its planned $2 billion Saratoga Springs manufacturing campus ...
By Siddhi Mahatole July 7 (Reuters) - The U.S. Food and Drug Administration has approved Vera Therapeutics' drug to treat ...
Earlier MS diagnosis is now possible, Zyn nicotine pouches get an FDA risk claim, and norovirus concerns rise with summer ...
Following the U.S. Food and Drug Administration’s recent authorization for Swedish Match USA, Inc. to market ZYN nicotine ...
ORIGIN 3 randomized 431 biopsy‑confirmed IgAN patients 1:1; atacicept 150 mg weekly SC produced the largest placebo‑adjusted UPCR reduction reported at week 36. Accelerated approval hinged on ...
Texas Agriculture Commissioner Sid Miller is urging the Food and Drug Administration to authorize ivermectin in medicated ...
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