Tag Archives: U.S.

U.S. FDA Approves Kite’s Tecartus as the First and Only CAR-T for Adults with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

[unable to retrieve full-text content]SANTA MONICA, Calif.–(BUSINESS WIRE) October 01, 2021 — Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has granted approval for Tecartus® (brexucabtagene autoleucel) for the treatment of… Drugs.com – New Drug Approvals

Biden says U.S. health officials are considering Covid booster shots at 5 months, moving up timeline of third shot

US President Joe Biden meets with Israeli Prime Minister Naftali Bennett in the Oval Office of the White House in Washington, DC, on August 27, 2021. Nicholas Kamm | AFP | Getty Images President Joe Biden said U.S. regulators are looking at administering Covid-19 booster shots five months after people finish their primary immunizations, moving… Read More »

Albireo’s rare liver disease drug Bylvay scores back-to-back approvals in U.S., Europe

With a pair of approvals on both sides of the Atlantic, liver disease-focused biotech Albireo is off and running with its new medicine Bylvay. The oral drug, the first treatment for pruritus in patients with progressive familial intrahepatic cholestasis (PFIC), scored an FDA nod Tuesday and a European approval Monday. With the FDA’s blessing, Albireo is kicking off an “immediate”… Read More »