Regulatory Affairs

Regulatory Affairs News

View news from other Pharmaceutical sectors:
16-30 of 3712 results
Cyprium Therapeutics’ CUTX-101 gets FDA fast track designation to treat classic Menkes disease
Fortress Biotech announced that the US Food and Drug Administration (FDA) has granted fast track designation to Cyprium Therapeutics Copper Histidinate, also referred to as CUTX-101, for patients diagnosed with classic Menkes disease who have not demonstrated significant clinical progression.
Regulatory Affairs > News
AstraZeneca gets regulatory approvals for two cancer drugs in Japan
By PBR Staff Writer
AstraZeneca has secured regulatory approvals for two major cancer drugs, Imfinzi and Lynparza, in Japan.
Regulatory Affairs > News
FDA approves Array BioPharma’s Braftovi/Mektovi melanoma combo treatment
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Array BioPharma’s oral combination treatment of Braftovi (encorafenib) capsules and Mektovi (binimetinib) tablets for a serious and deadly type of skin cancer.
Regulatory Affairs > News
FDA approves Achaogen’s Zemdri to treat adults with cUTI
By PBR Staff Writer
Achaogen has secured approval from the US Food and Drug Administration (FDA) for its Zemdri (plazomicin) to treat adults with complicated urinary tract infections (cUTI).
Regulatory Affairs > News
FDA approves Greenwich’s marijuana-derived drug for seizures
By PBR Staff Writer
Greenwich Biosciences, a subsidiary of UK-based GW Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for the Epidiolex (cannabidiol) oral solution to treat seizures associated with two severe childhood-onset epilepsies.
Regulatory Affairs > News
FDA approves label expansion for Shire’s HAE drug Cinryze
By PBR Staff Writer
Shire has secured a label expansion from the US Food and Drug Administration (FDA) for its hereditary angioedema (HAE) therapy Cinryze to help prevent angioedema attacks in HAE-affected children, aged 6 years and older.
Regulatory Affairs > News
ImmunoGen gets FDA fast track status for mirvetuximab soravtansine to treat platinum-resistant ovarian cancer
ImmunoGen has secured fast track designation from the US Food and Drug Administration (FDA) for its lead program, mirvetuximab soravtansine.
Regulatory Affairs > News
FDA approves Roche's Avastin plus chemotherapy for ovarian cancer after surgery
The US Food and Drug Administration (FDA) has approved Roche’s Avastin (bevacizumab) plus chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for treating women with stage III or IV ovarian cancer following initial surgical resection.
Regulatory Affairs > News
Albireo gets FDA rare pediatric disease designation for rare liver disease treatment A4250
By PBR Staff Writer
Albireo Pharma has secured rare pediatric disease designation from the US Food and Drug Administration for its product candidate, A4250, to treat progressive familial intrahepatic cholestasis (PFIC).
Regulatory Affairs > News
Ascletis' Ganovo gets CFDA approval for treatment of viral hepatitis C
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.
Regulatory Affairs > News
Merck's Keytruda secures FDA approval for advanced cervical cancer
By PBR Staff Writer
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.
Regulatory Affairs > News
AstraZeneca gets EC nod for Tagrisso as first-line treatment for EGFR-mutated NSCLC
By PBR Staff Writer
The European Commission (EC) has approved AstraZeneca's Tagrisso (osimertinib) as monotherapy for first-line treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
Regulatory Affairs > News
FDA approves AbbVie and Roche's Venclexta-rituximab combo for CLL
By PBR Staff Writer
AbbVie has secured approval from the US Food and Drug Administration (FDA) for the combination of Venclexta (venetoclax tablets) and rituximab for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Regulatory Affairs > News
Genentech’s Rituxan gets FDA approval to treat pemphigus vulgaris
By PBR Staff Writer
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).
Regulatory Affairs > News
Mylan, Biocon secure FDA nod for first biosimilar to cancer drug Neulasta
By PBR Staff Writer
Mylan and Biocon have secured approval from the US Food and Drug Administration for Fulphila (pegfilgrastim-jmbd), a biosimilar to Amgen’s cancer drug Neulasta (pegfilgrastim).
Regulatory Affairs > News
16-30 of 3712 results