Alexion Pharmaceuticals said that it has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA), seeking approval for its C5 complement inhibitor ALXN1210 for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH).
ImmunoGen has secured fast track designation from the US Food and Drug Administration (FDA) for its lead program, mirvetuximab soravtansine.
The China Food and Drug Administration (CFDA) has approved Ascletis' Category 1 new drug, Ganovo (Danoprevir or ASC08), for the treatment of viral hepatitis C.
The US Food and Drug Administration (FDA) has expanded the approval of Merck's anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of recurrent or metastatic cervical cancer in patients whose disease had progressed on or after chemotherapy.
Genentech, a subsidiary of Roche, has secured approval from the US Food and Drug Administration (FDA) for its antibody therapy Rituxan (rituximab) to treat adults with moderate to severe pemphigus vulgaris (PV).
Roche’s Hemlibra (emicizumab) has been granted priority review by the US Food and Drug Administration (FDA) for the treatment of haemophilia A without factor VIII inhibitors in both adults and children.
The European Commission (EC) has approved Roche’s Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen) for post-surgery treatment of adults with HER2-positive early breast cancer (eBC) at high risk of recurrence.
The US Food and Drug Administration (FDA) has approved a lower dose of Olumiant (baricitinib), a daily once oral Janus kinase (JAK) inhibitor developed by Lilly and Incyte to treat moderately-to-severely active rheumatoid arthritis (RA).
Pfizer’s Janus kinase (JAK) inhibitor Xeljanz (tofacitinib) has been approved by the US Food and Drug Administration (FDA) to treat adult patients with moderately to severely active ulcerative colitis.
The European Commission (EC) has authorized Clovis Oncology’s Rubraca (rucaparib) for the treatment of women with recurrenr ovarian cancer.
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.