Breast Implants: FDA Issues Stronger Risk Warning Labels
The US FDA (Food and Drug Administration) has announced new labels for boxed warnings, to further warn and inform consumer decision-making when considering the risks around breast implants. Included in this announcement, the FDA will also be limiting the sale and...
Daytime Sleepiness (EDS): EMA Approves Bioprojet Ozawade
Bioproject has received approval from the European Medicines Agency (EMA) for their Ozawade (pitolisant) to treat adult excessive daytime sleepiness (EDS) associated with obstructive sleep apnoea (OSA). The approval is based on two Phase III clinical studies to study...
Novavax Files for UK Authorization for its COVID-19 Vaccine
Novavax, a biotechnology company committed to development and bringing to market next-generation vaccines for critical infectious diseases, announced that it has finalized its ongoing regulatory submission to the U.K. Medicines and Healthcare products Regulatory...
Solasia & Nippon Kayaku File for Darinaparsin License Agreement
Solasia Pharma K.K (Salasia) and Nippon Kayaku (Nippon) have announced their joint license agreement for marketing rights for darinaparsin (SP-02) in Japan. Drug candidate developed by Salasia, darinaparsin, aims to treat relapsed or refractory peripheral T-cell...
Resilia Solace Eczema Cream Granted US Commercialization
Resilia Pharmaceuticals has been granted the rights to manufacture, commercialize and sell Solace™ Eczema Cream, a medical device, as an OTC (over the counter) product in the United States. Signing the agreement with Pelle Ventures, the deal will make the cream more...
Ultimovacs Receives Fast Track Designation for Cancer Drug
The US Food and Drug Administration (FDA) has given Norwegian pharmaceutical company Ultimovacs ASA Fast Track designation for its experimental product, UV1, as a supplementary therapy to either pembrolizumab or ipilimumab for the treatment of unresectable or...
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