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The European Medicines Agency (EMA) is now reviewing Johnson & Johnson’s (J&J) conditional marketing authorization application for its COVID-19 vaccine, a single-dose inoculation that would help to simplify the EU’s vaccination efforts. Read More
Breyanzi (lisocabtagene maraleucel) will be manufactured for each individual patient at the company’s cellular immunotherapy manufacturing facility in Bothell, Wash. Read More
The agency approved the label change after concluding that an acceptable amount of overfill will remain in each vial after extracting six doses. Read More
The U.S. has secured a hefty supply of COVID-19 monoclonal antibodies, but challenges in administering the potentially game-changing treatments and skepticism around their efficacy have contributed to their minimal use. Now, a newly issued Emergency Use Authorization (EUA) for an antibody combo could inspire greater assurance in the drugs as potential treatments for preventing hospitalization. Read More
The company said it “remains committed to making its vaccine available” in India and plans to resubmit its approval request with additional information as it becomes available. Read More
The FDA has approved Bristol Myers Squibb’s CAR T cell therapy Breyanzi for treatment of adults with relapsed or refractory large B-cell lymphoma, an aggressive form of non-Hodgkin lymphoma. Read More