Regulatory Affairs

Regulatory Affairs News

View news from other Pharmaceutical sectors:
1-15 of 3690 results
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
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
Pfizer’s Xeljanz gets FDA approval for ulcerative colitis
By PBR Staff Writer
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.
Regulatory Affairs > News
FDA grants priority review to Loxo's larotrectinib for several solid tumors
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted Loxo Oncology’s new drug application (NDA) and granted priority review for larotrectinib to treat adult and pediatric patients with locally advanced or metastatic solid tumors harboring an neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
Regulatory Affairs > News
EC authorizes Clovis Oncology’s Rubraca to treat women with recurrent ovarian cancer
The European Commission (EC) has authorized Clovis Oncology’s Rubraca (rucaparib) for the treatment of women with recurrenr ovarian cancer.
Regulatory Affairs > News
AB Science plans to resubmit marketing application in Europe for ALS treatment masitinib
By PBR Staff Writer
AB Science is evaluating options to resubmit the marketing authorization application (MAA) in Europe for its amyotrophic lateral sclerosis treatment (ALS), masitinib.
Regulatory Affairs > News
EC approves Sandoz' Zessly to treat gastroenterological, rheumatological and dermatological diseases
Sandoz has secured approval from the European Commission for Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases.
Regulatory Affairs > News
1-15 of 3690 results