Novartis said that the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for brolucizumab (RTH258) as a potential treatment for wet age-related macular degeneration (AMD).
OTITOPIC recently announced a new additional indication for treatment of lung cancer for its aspirin inhalation product.
Gilead Sciences has announced that it is seeking approval from the US Food and Drug Administration (FDA) for its once-daily Descovy tablets to treat HIV pre-exposure prophylaxis (PrEP).
Circassia Pharmaceuticals announced that the US Food and Drug Administration (FDA) added new data to the TUDORZA PRESSAIR (aclidinium bromide inhalation powder) prescribing information that includes data from the ASCENT trial showing that TUDORZA PRESSAIR reduces exacerbations in chronic obstructive pulmonary disease (COPD) and does not increase major adverse cardiovascular events (MACE) in COPD patients with cardiovascular disease and/or significant cardiovascular risk factors.
Celgene Corporation (NASDAQ:CELG), today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for two triplet regimens based on Celgene’s proprietary IMiD medications, REVLIMID (lenalidomide) and IMNOVID (pomalidomide).
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Type II variation application to the European Medicines Agency (EMA) for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone (Rd) for the treatment of patients newly diagnosed with multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
Sanofi has secured priority review from the US Food and Drug Administration (FDA) for its human monoclonal antibody Dupixent (dupilumab) as an add-on maintenance treatment for severe chronic rhinosinusitis with nasal polyps (CRSwNP).
The National Institute for Health and Care Excellence (NICE) in the UK is seeking additional data on Amgen’s Blincyto (blinatumomab) to treat adults with acute lymphoblastic leukaemia (ALL).
Celgene announced that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for fedratinib and granted a Priority Review.
Alexion Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for the use of SOLIRIS (eculizumab), the company’s first C5 complement inhibitor, as a treatment for patients with neuromyelitis optica spectrum disorder (NMOSD) who have anti-aquaporin-4 (AQP4) auto antibodies.
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