Pfizer and Biopharmaceutical New Technologies (BioNTech) have secured fast track designation from the US Food and Drug Administration (FDA) for two investigational mRNA-based vaccine candidates against SARS-CoV-2, the novel coronavirus responsible for the Covid-19 disease.
AstraZeneca and Merck have secured approval from the European Union (EU) for the Lynparza as a maintenance treatment for adult patients with germline BRCA-mutated metastatic pancreatic cancer.
Neurogene, a company founded with a mission to bring life-changing genetic medicines to patients and families affected by rare neurological diseases, today announced that the US Food and Drug Administration (FDA) granted Orphan Drug Designation to adeno-associated virus vector with engineered transgene encoding the human CLN5 gene for patients with CLN5, a form of Batten disease.
Gilead Sciences has secured conditional marketing authorisation from the European Commission for its Veklury (remdesivir) to treat SARS-CoV-2 infection, which is responsible for the Covid-19 disease.
Specialist HIV company ViiV Healthcare has secured approval from the US Food and Drug Administration (FDA) for its Rukobia (fostemsavir) 600mg extended-release tablets to treat HIV in adult patients.
Janssen Pharmaceutical, part of Johnson & Johnson, has secured marketing authorisation from the European Commission (EC) for its Ebola vaccine regimen to prevent Ebola virus disease.
Oncternal Therapeutics, a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, announced that the United States Food and Drug Administration (FDA) has granted the company orphan drug designations of cirmtuzumab for treatment of mantle cell lymphoma (MCL) and for treatment of chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL).
Pfizer has secured approval from the European Commission (EC) for its Daurismo (glasdegib) to treat certain adult patients with newly diagnosed acute myeloid leukaemia (AML).
GlaxoSmithKline (GSK) has secured approval in Japan for Duvroq (daprodustat) tablets for the treatment of anaemia caused by chronic kidney disease (CKD).
Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
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