Approvals
As the FDA cracks down on accelerated approvals, Genentech, a Roche company, voluntarily withdrew its monoclonal antibody, Tecentriq, for metastatic bladder cancer.
The FDA granted priority review to Takeda’s Biologics License Application for TAK-003, a dengue vaccine candidate. The vaccine to date is only approved for use in Indonesia.
The FDA approved CSL Behring and uniQure’s Hemgenix, a one-time gene therapy developed for adults with Hemophilia B,the companies announced Tuesday afternoon.
The FDA has approved Provention’s BLA for intravenous antibody TZIELD to delay stage 3 type 1 diabetes, making it the first disease-modifying drug indicated to slow disease progression.
ImmunoGen’s Elahere was approved Monday under the FDA’s accelerated pathway for patients who have received one to three previous lines of systemic therapy.
The FDA approved AstraZeneca’s Imfinzi in combination with Imjudo and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer.
Seagen’s Adcetris has been given FDA approval for the treatment of children aged two years and above with high-risk classical Hodgkin lymphoma.
Ipsen will seek a new approval for Onivyde as a treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) after posting positive Phase III progression survival data.
The FDA greenlit Libtayo plus chemotherapy to treat patients with advanced NSCLC irrespective of EGFR, ALK or ROS1 aberrations. It is the drug’s second approval in this space.
A request for additional data may cause a 3-month delay for potential approval of BioMarin Pharmaceutical’s hemophilia A gene therapy.
PRESS RELEASES