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).
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A Phase III trial of Axsome Therapeutics’ AXS-05 hit both the primary and secondary endpoints in patients with Alzheimer’s disease agitation, the New York-based company announced Monday.
The World Health Organization said it would start using a new preferred term, ‘mpox’, as a synonym for monkeypox and urged others to follow suit after receiving complaints that the current name for the disease was racist and stigmatising.
Brand Institute, the global leader in pharmaceutical and healthcare-related brand name and identity development, is pleased to share that Denmark-based Bavarian Nordic’s smallpox and monkeypox vaccine, named JYNNEOS®, was selected by TIME Magazine as one of the best inventions of 2022.
Many biopharma companies raised funds in 2022, but not enough to reach their next milestone. Investors have been constricting investments, so companies needing additional funding require a larger toolbox.
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).
British drug discovery company C4X Discovery said AstraZeneca signed a license worth up $402 million to develop an oral therapy for the treatment of inflammatory and respiratory diseases using its NRF2 Activator programme.
Late Monday, Arvinas Inc. was forced to divulge the contents of its upcoming breast cancer data presentation, slated for the 2022 San Antonio Breast Cancer Symposium (“SABCS”). The clinical-stage biopharma was originally set to unveil the Phase II data for its lead breast cancer medication, ARV-471, on Dec. 8, 2022. But Arvinas’ and Pfizer’s joint abstract was inadvertently published early for conference participants by SABCS. Arvinas’ stock price has since fallen by 18% over the first two days of the holiday-shortened week.
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.