Daiichi Sankyo has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for trastuzumab deruxtecan (DS-8201), a HER2 directed antibody drug conjugate (ADC), for the treatment of patients with HER2 positive metastatic gastric cancer.
Novartis has secured approval from the US Food and Drug Administration (FDA) for its Tabrecta (capmatinib) to treat adult patients metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping (METex14).
Acceleron Pharma said that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to sotatercept for the treatment of patients with pulmonary arterial hypertension (PAH).
Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for CC-486 for the maintenance treatment of adults in remission with acute myeloid leukemia (AML)
The US Food and Drug Administration (FDA) has given its emergency use authorisation (EUA) for Gilead Sciences' investigational antiviral remdesivir for the treatment of Covid-19.
Banner Life Sciences, a privately held specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) granted final approval of BAFIERTAM (monomethyl fumarate) delayed-release capsules for the treatment of relapsing forms of multiple sclerosis (MS).
GlaxoSmithKline announced the US Food and Drug Administration (FDA) approved the company’s supplemental New Drug Application (sNDA) for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status.
Merck said that the US Food and Drug Administration (FDA) has given its approval for the use of its cancer drug KEYTRUDA (pembrolizumab) at an additional dosage of 400mg every six weeks (Q6W) across all indications in adult patients.
Takeda Pharmaceutical has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its investigational drug mobocertinib (TAK-788) to treat patients with metastatic non-small cell lung cancer (NSCLC).
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of two supplemental Biologics License Applications (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of SIMPONI ARIA® (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA), in patients two years of age and older in combination with methotrexate
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