FDA Authorizes Novavax’s COVID-19 Vaccine
The FDA has granted Emergency Use Authorization (EUA) to Novavax’s COVID-19 vaccine. Source: Drug Industry Daily
The FDA has granted Emergency Use Authorization (EUA) to Novavax’s COVID-19 vaccine. Source: Drug Industry Daily
Just before their trial wrapped up, Allergan and Teva Pharmaceuticals reached a $54 million settlement agreement with the city of San Francisco over the companies’ role in the opioid crisis…
Viatris, formerly Mylan, now must pay out a settlement of $264 million to consumers, insurers and pension funds who sued the company over steep price spikes for EpiPen, which is…
Astellas Pharma and two other plaintiffs have filed a patent infringement lawsuit in an effort to stop Zydus Pharmaceuticals from marketing a generic version of the prostate cancer drug Xtandi…
Catalyst Pharmaceuticals has settled with Jacobus Pharmaceutical over claims that Jacobus’ Lambert-Eaton myasthenic syndrome (LEMS) drug Ruzurgi (amifampridine) infringed on its patent rights for Firdapse (amifampridine). Source: Drug Industry Daily
The FDA would be compelled to finalize a 15-year old proposed rule requiring drugmakers to cease using distracting images and sounds in TV ads under a new bill introduced in…
Five months into his tenure as FDA commissioner, Robert Califf warned that the agency’s ability to review medical products would be drastically curtailed if Congress doesn’t pass a user fee…
The FDA has received heavy pushback from industry groups on its revised plan to collect quality metrics data from manufacturers, according to public comments on two volunteer pilots, the Site…
Perrigo is jockeying for FDA approval for what could become the first ever over-the-counter (OTC) birth control pill in the U.S. Source: Drug Industry Daily
Novo Nordisk made some headlines in London this week, presenting positive data from hemophilia therapeutics trials at the International Society of Thrombosis and Hemostasis Annual Congress. Source: Drug Industry Daily