Approvals
A U.S. FDA committee gave the nod to continue using Genentech’s checkpoint inhibitor Tecentriq in combination with chemotherapy to treat adults with mTNBC.
Takeda’s non-small cell lung cancer treatment Mobocertinib is leading closer to regulatory approval after the U.S. Food and Drug Administration granted priority review to the New Drug Application.
Top-line results from the Phase III INVIGORATE trial show Aldeyra Therapeutics’, reproxalap, significantly reduced ocular itching in patients with allergic conjunctivitis.
Enzyvant has resubmitted its Biologics Licensing Application to the U.S. FDA for its tissue-based regenerative pediatric congenital athymia therapy RVT-802.
There is hope for uniQure’s HOPE-B trial after all. Shares of uniQure NV are climbing this morning after the company announced the clinical hold on its hemophilia B gene therapy has been lifted by the U.S. Food and Drug Administration.
The approval was specifically for patients with recurrent or advanced endometrial cancer who had progressed on or after previous treatment with platinum-based chemotherapy and whose cancers have a dMMR genetic anomaly.
Amgen announced the U.S. FDA awarded Breakthrough Therapy Designation to the bemarituzumab as a first-line treatment for certain types of gastric cancer.
Opdivo, the trade name for the generic Nivolumab, can now be used in combination with certain types of chemotherapy for initial treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.
The reason for the request was the monotherapy antibody therapy is less effective against the COVID-19 variants, such as have risen from the U.K., South Africa and Brazil, as well as the growing B.1.427/B.1.429 California variant.
The approval marks the second approval for Trodelvy, which Gilead gained through its $21 billion acquisition of Immunomedics.
PRESS RELEASES