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Seattle-based Omeros has been hit with a Complete Response Letter (CRL) from the FDA regarding its biologics license application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Read More
In a Complete Response Letter (CRL) to United Therapeutics, the FDA declined to approve the company’s Tyvaso DPI (treprostinil) drug-device combination for improving exercise capacity in patients with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Read More
In a move expected to seriously cut into U.S. sales of AbbVie’s blockbuster immunosuppressive drug, Humira (adalimumab), the FDA has approved the first interchangeable Humira biosimilar product to treat inflammatory diseases. Read More
Roche’s blockbuster monoclonal antibody Tecentriq (atezolizumab) got another approval from the FDA, this time for certain nonsmall-cell lung cancer (NSCLC) patients. Read More
Researchers from the National Institutes of Health (NIH) have found that a “mix and match” approach using different COVID-19 booster vaccines is safe and effective. Read More
Merck and Ridgeback Biotherapeutics have become the first companies to file an application seeking Emergency Use Authorization (EUA) for an oral antiviral that treats COVID-19 — which could transform treatment of infections with the deadly virus. Read More
Rethymic, a cultured human thymus tissue developed by Enzyvant, has won FDA approval as the first-ever thymus tissue transplant product approved in the U.S. Read More