Tags : Epizyme

Insights+: The US FDA New Drug Approvals in December 2019

The US FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 48 new products so far in 2019. In 2018, FDA approved 59 novel products including 42 New Chemical Entity and 17 Biologics while breaking its past year’s records of approval. However, there is a significant […]Read More

PharmaShots Weekly Snapshot (February 10-14, 2020)

1. Epizyme Reports the US FDA Acceptance of NDA for Tazverik (tazemetostat) to Treat Follicular Lymphoma Published: Feb 14, 2020 | Tags: Epizyme, Reports, US, FDA, Acceptance, NDA, Tazverik, tazemetostat, Follicular Lymphoma 2. Soligenix’s RiVax Receives the US FDA’s Fast Track Designation for the Prevention of Ricin Poisoning Published: Feb 13, 2020 | Tags: Soligenix, RiVax, Receives, […]Read More

Epizyme Reports the US FDA Acceptance of NDA for Tazverik

Shots: The US FDA has accepted NDA for the accelerated approval of Tazverik for patients with relapsed/refractory FL prior treated with 2L+ systemic therapies The US FDA has granted PR and designated its NDA as sNDA. The sNDA is based on P-II study that demonstrated clinical benefits and was well tolerated in FL patients with […]Read More

PharmaShots Weekly Snapshot (January 20-24, 2020)

1. Epizyme’s Tazverik (tazemetostat) Receives the US FDA’s Accelerated Approval as the First Therapy for Epithelioid Sarcoma Published: Jan 23, 2020 | Tags: Epizyme, Tazverik, tazemetostat, Receives, US, FDA, Accelerated Approval, First Therapy, Epithelioid Sarcoma 2. Evarsana Signs an Agreement with Evoke Pharma to Commercialize Gimoti in the US Published: Jan 23, 2020 | Tags: Evarsana, Signs, […]Read More