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The FDA gave the generic antidepressant fluvoxamine a decisive thumbs-down as a treatment option for COVID-19 this week, only days after an influential independent nonprofit research panel recommended it. Read More
Acella Pharmaceuticals is facing a potential class action lawsuit in a federal court in Georgia that claims its NP Thyroid hormone replacement drug is “worthless” and left one patient with “hypothyroidism, including hair loss, extreme fatigue, painful sensitivity to temperature changes and debilitating hives.” Read More
The FDA issued over-the-counter (OTC) drug and cosmetic manufacturer Allure Labs a four-observation Form 483 following a November to December 2021 inspection of its Hayward, Calif., facility, noting procedural lapses and possible underreporting of deviations, nonconformances and out-of-specification (OOS) events. Read More
A group of generic drugmakers pledged to manufacture versions of Pfizer’s COVID-19 antiviral pill Paxlovid (nirmatrelvir/ritonavir) for use in the developing world and agreed to price them at $25 or less per treatment course. Read More
UCB drew a Complete Response Letter (CRL) from the FDA rejecting the company’s Biologics License Application (BLA) for its investigational monoclonal antibody drug bimekizumab in adult patients with moderate-to-severe plaque psoriasis. Read More