Government
An FDA advisory committee overwhelmingly votes in support of Sage’s post-partum depression drug, clearing the way for regulatory approval.
The U.S. Food and Drug Administration issued a voluntary recall of a medication to treat high blood pressure due to trace amounts of a carcinogen being found within some lots of the drug.
The U.S. Food and Drug Administration (FDA) gave the green light to Hyrimoz, a biosimilar to AbbVie’s blockbuster drug Humira, five years ahead of the time it can be launched in U.S. markets.
The U.S. Food and Drug Administration (FDA) and Department of Homeland Security (DHS) are celebrating National Cybersecurity Awareness Month by announcing a strengthened partnership to buff up medical device cybersecurity, increasing communication and coordination between the two agencies.
Noting advances in genetic manipulation and gene editing, the Food and Drug Administration announced a new Plant and Animal Biotechnology Innovation Action Plan.
To suggest that the pharma industry is a reluctant partner in President Donald Trump’s attempts to decrease drug prices is to overstate the fact. But now the industry appears to be pushing back, at least a little bit.
One of the drugs being discussed this week by a U.S. Food and Drug Administration advisory committee is Waltham, Mass.-based Alkermes’ ALKS-5461. The drug itself has some controversy.
Merck’s blockbuster anti-PD-1 therapy Keytruda has snagged another regulatory approval from the U.S. Food and Drug Administration. The checkpoint inhibitor has been approved, in combination with chemotherapy, as a first-line treatment for patients with metastatic squamous non-small cell lung cancer.
Four former Genentech employees have been indicted by a federal grand jury for the alleged theft of company trade secrets in order to help a company set up in Taiwan develop drugs similar to those made by the Roche subsidiary.
In the wake of a significant number of journal articles being retracted due to falsified data, the National Heart, Lung, and Blood Institute, part of the National Institutes of Health, is halting a clinical trial that is testing an experimental stem cell therapy for heart patients.
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