Regulatory Affairs
Search Results: Regulatory Affairs
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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
New Pharma Biotech eLearning Available from NSF
NSF have added two new eLearning sessions to its online portal. NSF’s new pharma biotech eLearning includes short, targeted, highly focused “how to” sessions on common industry themes as well as introductions and overviews on topics essential for those new to the industry. Learn from NSF’s trusted industry experts and take away tools and techniques that can be used instantly in the workplace.
Regulatory Affairs > Press Releases
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
European Commission approves Perjeta and Herceptin combo
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.
Regulatory Affairs > News
Lilly and Incyte gain FDA approval for lower dose of RA drug Olumiant
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).
Regulatory Affairs > News
Data Integrity A Closer Look
| By NSF International
Data integrity remains a perennial hot topic impacting the pharma biotech industry and the trend has been picking up steam; the number of data integrity-related warning letters has increased consistently since 2010. A number of new guidance documents came out in 2016 by FDA, MHRA, EMA PIC/S and the WHO and yet companies continue to grapple with data integrity issues.
Regulatory Affairs > White Papers
Preparing For A Regulatory Inspection
Learn how we helped a company prepare for a regulatory inspection. The key message that came from the project was that you need to approach inspection preparation in an open and collaborative manner. Sites will have the answers to the questions if the right people are asked.
Regulatory Affairs > Case Studies
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