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A Wyoming manufacturer of dietary supplements claimed drug-like qualities for its products without obtaining the drug-marketing approvals that such claims require, the FDA said in a warning letter. Read More
A libertarian advocacy group that backs right-to-try laws pressed the FDA in federal court to release information about the agency’s “incredibly expeditious” decision to authorize the treatment of two Ebola patients with an unapproved drug. Read More
The European Medicines Agency added answers to 60 new questions in its list of inquiries from stakeholders regarding the November launch of its new EudraVigilance drug safety reporting program. Read More
FDA Commissioner Scott Gottlieb will deliver a keynote address Nov. 8 at a public FTC workshop in Washington on competition in prescription drug markets. Read More
More than 6,000 plaintiffs filed similar cases against the company, but the verdict is the second one against AbbVie in a series of “bellwether” trials. Read More
Valporate, a treatment for migraine headaches, epilepsy and bipolar disorder, can cause malformations and impede neurological development in babies in the womb. Read More
A Washington state pharmacy used ingredients that are not covered by a designated monograph in compounding drugs, meaning it lost its exemption for labeling requirements, and also failed to maintain sanitary conditions for drug production, the FDA said in a warning letter. Read More
Amgen asked a federal court to declare that its newly approved biosimilar Mvasi does not violate 27 patents Genentech holds on Avastin, the reference cancer drug Genentech is trying to defend. Read More
The European Medicines Agency added new safety information for 15 excipients, including five new ingredients, in its listings of required product labeling. Read More