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As the FDA cracks down on accelerated approvals, Genentech, a Roche company, voluntarily withdrew its monoclonal antibody Tecentriq (atezolizumab) for a specific type of previously untreated metastatic bladder cancer.  

The FDA has accepted Roche and Sarepta’s Biologic License Application for the accelerated approval of SRP-9001 (delandistrogene moxeparvovec), an investigational gene therapy for Duchenne muscular dystrophy (DMD).

Kintara Therapeutics Inc., a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Kintara’s REM-001 Therapy for the treatment of patients with cutaneous metastatic breast cancer (CMBC).

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.

BioMarin Pharmaceutical announced the FDA no longer plans to hold an advisory committee meeting to review its Biologics License Application (BLA) for Roctavian (valoctocogene roxaparvovec), an AAV gene therapy for adults with severe hemophilia A.

Spectrum Pharmaceuticals Inc. said on Friday the U.S. Food and Drug Administration (FDA) declined to approve its experimental lung cancer drug due to inadequate data, prompting the drugmaker to cut jobs.

Philips, which has been struggling with a major recall of ventilators, on Monday flagged further problems with some machines it has previously replaced, according to an FDA statement.

Seagen is on a roll this week. After naming David R. Epstein as its new CEO, the Washington-based biotech announced that Adcetris (brentuximab vedotin) has been given FDA approval for the treatment of children aged two years and above with high-risk classical Hodgkin lymphoma. 

GSK’s oncology business suffers fresh blow with Zejula setback By Natalie Grover and Pushkala Aripaka Nov 11 (Reuters) – Britain’s GSK (GSK.L) said on Friday it would limit the use of its ovarian cancer drug Zejula in the United States as a second treatment option to keep cancer at bay in patients whose tumors carry […]

BrainStorm Cell Therapeutics ran into another stumbling block with ALS hopeful NurOwn Thursday as the FDA issued a Refusal to File Letter for its Biologics License Application.