On February 5, 2021, the FDA approved Juno Therapeutics, Inc.’s Breyanzi® (lisocabtagene maraleucel) for “treatment of adult patients with relapsed or refractory large B-cell lymphoma.” Juno, a Bristol-Myers Squibb Company,...more
The last two years saw the launch of several biosimilars. Looking ahead to 2021, several others may be on the horizon. In 2019-2020, the FDA approved thirteen biosimilars directed to seven reference products. Eight of the...more
On October 6, FDA issued updated guidance for industry concerning “Emergency Use Authorization for Vaccines to Prevent COVID-19,” updating the previous guidance issued in June. The updated guidance, which is being...more