Sunovion Pharmaceuticals and PsychoGenics have secured the breakthrough therapy designation from the US Food and Drug Administration (FDA) for their jointly owned psychotropic agent SEP-363856 for the treatment of schizophrenia.
ViiV Healthcare is seeking approval from the US Food and Drug Administration (FDA) for the investigational, monthly, injectable, two-drug regimen of cabotegravir and rilpivirine to treat HIV.
AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending LYNPARZA as a first-line maintenance treatment in BRCA-mutated advanced ovarian cancer.
Celgene and Acceleron Pharma have a filed an application with the European Medicines Agency (EMA) seeking approval for luspatercept for the treatment of anemia associated with myelodysplastic syndromes (MDS) and beta-thalassemia.
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).
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