European biotech AlgoTherapeutix, an innovator in complex pain therapy, announces the U.S. Food and Drug Administration (FDA) has granted ATX01 (proprietary topical amitriptyline) Orphan Drug Designation for the treatment of erythromelalgia.
Merck has secured approval from the US Food and Drug Administration (FDA) for its Recarbrio (imipenem, cilastatin, and relebactam) to treat adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
Johnson & Johnson’s Janssen Pharmaceutical has secured approval from the European Commission for the subcutaneous formulation of Darzalex (daratumumab) for the treatment of multiple myeloma in adult patients.
Pierre Fabre has secured approval from the European Commission (EC) for Braftovi (encorafenib) plus cetuximab (Erbitux) to treat adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) who have received prior systemic therapy.
Sanofi has secured approval from the European Commission (EC) for Sarclisa (isatuximab) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of relapsed and refractory multiple myeloma (MM) in adult patients.
AVEO Oncology announced that the U.S. Food and Drug Administration (FDA) accepted for filing its New Drug Application (NDA) seeking approval for tivozanib, the Company’s next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), as a treatment for relapsed or refractory renal cell carcinoma (RCC).
AstraZeneca has secured approval from the US Food and Drug Administration (FDA) for its Brilinta (ticagrelor) to minimise the risk of a first heart attack or stroke in high-risk patients with a heart disease known as coronary artery disease (CAD).
Genentech has secured approval from the US Food and Drug Administration (FDA) for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of unresectable or metastatic hepatocellular carcinoma (HCC).
Bird Rock Bio has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a phase 2 clinical study of nimacimab, also known as RYI-018, in patients with one of the following renal diseases: diabetic kidney disease, focal segmental glomerulosclerosis (FSGS), or immunoglobulin A (IgA) nephropathy.
Bristol Myers Squibb announced that the European Commission (EC) has approved Zeposia (ozanimod) for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.
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