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.
Concert Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the Company’s oral Janus kinase inhibitor, CTP-543, for the treatment of adult patients with moderate-to-severe alopecia areata.
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.
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for trastuzumab deruxtecan, a HER2 directed antibody drug conjugate (ADC), for the treatment of adults with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens.
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).
Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.