Tesaro, a GlaxoSmithKline (GSK) company, has secured priority review designation for its polymerase (PARP) inhibitor ZEJULA (niraparib) from the US Food and Drug Administration (FDA) for the treatment of late stage ovarian cancer.
The US Food and Drug Administration (FDA) has accepted Alexion Pharmaceuticals’ supplemental biologics licence application (sBLA) for priority review of Ultomiris to treat people with aHUS and inhibition of complement-mediated thrombotic microangiopathy (TMA).
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has selected the triple combination of the next-generation corrector VX-445 (elexacaftor), tezacaftor and ivacaftor to submit for potential global regulatory approvals for people ages 12 and older with cystic fibrosis (CF).
Epizyme has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for accelerated approval of tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery.
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.
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