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The first drug candidate submitted to the FDA for approval in HSCT-TMA, narsoplimab, has Breakthrough Therapy and Orphan Drug designations for HSCT-TMA and IgA nephropathy. Read More
Tecentriq treatment after surgery and platinum-based chemotherapy lowered the disease recurrence or mortality risk by 34 percent vs. best supportive care, Roche said. Read More
Oyster Point Pharma’s dry eye treatment, Tyrvaya (varenicline), has won FDA approval as the first nasal spray in the U.S. to treat the chronic condition. Read More
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