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The European Medicines Agency’s (EMA) safety committee said it found no evidence for a causal link between the Pfizer/BioNTech and Moderna COVID-19 vaccines and very rare cases of autoimmune hepatitis (AIH). Read More
Dropping from a high of 47 requests for Regenerative Medicine Advanced Therapy (RMAT) designations in 2018, the FDA has received, so far, just 14 requests this year, according to new data from the FDA’s Center for Biologics Evaluation and Research (CBER). Read More
Claims by CofixRX for its iodine-containing nasal spray render it an unapproved new drug that is misbranded and adulterated, the FDA said, in a warning letter to the company in Rochester Hills, Mich. Read More
Last week’s Aduhelm coverage decision by the Centers for Medicare and Medicaid Services (CMS) raises the bar for three other antiamyloid antibodies in late-stage development: Eisai’s and Biogen’s lecanemab, Eli Lilly’s donanemab and Roche’s gantenerumab. It all depends on the evidence that the drugmakers provide in their submissions to the FDA. Read More
The FDA and Centers or Medicare and Medicaid Services (CMS) took the rare step Friday of issuing a joint statement to clarify their regulatory authorities one day after the CMS made a controversial decision on who will have Medicare-paid access to the Alzheimer’s drug Aduhelm (aducanumab). Read More
The FDA is proposing a rating system to assess drugmakers’ quality management maturity (QMM) as a way to protect against drug shortages and bolster the U.S. supply chain. Read More
The FDA has released final guidance marking the agency’s adoption of the International Council for Harmonization (ICH)’s E8(R1) guidelines on clinical trials, which call for a “quality by design” approach. Read More
Sensory Cloud of Boston, Mass., has received a warning letter from the FDA for promoting an unapproved saline spray device as a COVID-19 treatment. Read More