Supplemental Biologics License Application (sBLA)

FDA Rejects Merck’s 6-Week Dosing Schedule for Keytruda

Blockbusters, Checkpoint Inhibitors, Classical Hodgkin Lymphoma, Complete Response Letter, Dosing, FDA, FDA/Regulatory, Gastric Cancer, Hepatocellular Carcinoma, Melanoma, Merkel cell carcinoma, Primary Mediastinal B-Cell Lymphoma (PMBCL), Supplemental Biologics License Application (sBLA)

Merck’s Keytruda (pembrolizumab) received a rejection from the U.S. Food and Drug Administration for each of six supplemental Biologics License Applications to update the dosing frequency of the checkpoint inhibitor to include every-six-weeks administration.

February 19, 2020/by BioSpace

FDA Grants Priority Review to Genentech’s Tecentriq Monotherapy as First-line Treatment of Certain People With Advanced Non-small Cell Lung Cancer

ALK Mutations, Biomarkers, Blockbusters, EGFR Mutations, FDA, FDA/Regulatory, Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC), Metastatic Squamous Non-Small Cell Lung Cancer, PD-1/PD-L1 inhibitors, Priority Review, Supplemental Biologics License Application (sBLA)

Roche Group member Genentech announced that the U.S. Food and Drug Administration accepted the company’s supplemental Biologics License Application and granted Priority Review for Tecentriq (atezolizumab) as a first-line monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer without EGFR or ALK mutations with high PD-L1 expression, as determined by PD-L1 biomarker testing.

February 19, 2020/by Business Wire

FDA Action Alert: Merck, Baudax Bio, Alder and Esperion

Blockbusters, FDA, FDA/Regulatory, Moderate Pain, Oncology, Pain, Severe Pain, Supplemental Biologics License Application (sBLA)

The U.S. Food and Drug Administration’s busy schedule for drug reviews includes six supplemental BLAs for Merck’s blockbuster oncology brand Keytruda.

February 17, 2020/by BioSpace

FDA Approves Botox for Pediatric Patients with Upper Limb Spasticity

Approvals, Brain Damage, FDA, FDA/Regulatory, Priority Review, Spine Damage, Supplemental Biologics License Application (sBLA), Upper Limb Spasticity

The U.S. Food and Drug Administration approved Allergan plc’s supplemental biologics application for Botox for the treatment of pediatric patients (2 to 17 years of age) with upper limb spasticity.

June 21, 2019/by PR Newswire

FDA Approves Eylea for Diabetic Retinopathy

Approvals, Diabetic Macular Edema, Diabetic Retinopathy, Diabetics, FDA, FDA/Regulatory, New Indications, Supplemental Biologics License Application (sBLA), Vascular Endothelial Growth Factor (VEGF) Inhibitors, Vision Loss, Wet Age-Related Macular Degeneration

The U.S. FDA approved Regeneron Pharmaceuticals Inc.’s Eylea (aflibercept) Injection for all stages of diabetic retinopathy, which is the leading cause of vision loss in diabetic patients.

May 14, 2019/by BioSpace

FDA accepts Roche’s supplemental biologics license application for Tecentriq plus chemotherapy for initial treatment of metastatic non-squamous non-small cell lung cancer

Blockbusters, FDA, FDA/Regulatory, Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC), Supplemental Biologics License Application (sBLA), Therapeutics

Roche announced that the U.S. Food and Drug Administration accepted the company’s supplemental Biologics License Application (sBLA) for Tecentriq in combination with Abraxane and carboplatin for the initial treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumor aberrations.

January 17, 2019/by GlobeNewswire

FDA Requests Another Trial for Pharming’s Ruconest Label Expansion

Adolescents, Adults, Clinical Trials, Complete Response Letter, FDA/Regulatory, Genetic Disorders, Hereditary Angioedema (HAE), Pompe disease, Shares, Supplemental Biologics License Application (sBLA)

The U.S. FDA issued a Complete Response Letter to Netherlands-based Pharming Group for the company’s supplemental Biologics License Application for Ruconest.

September 19, 2018/by BioSpace

GSK says U.S. FDA wants more information on pulmonary drug

Chronic Obstructive Pulmonary Disease (COPD), Complete Response Letter, FDA/Regulatory, Severe Asthma, Supplemental Biologics License Application (sBLA)

GlaxoSmithKline said U.S. health authorities asked for more information about the company’s Nucala drug for use in combating chronic obstructive pulmonary disease (COPD).

September 7, 2018/by Reuters Health

Merz Snags FDA Approval for Chronic Sialorrhea

Approvals, FDA/Regulatory, Neurodegenerative Diseases, Sialorrhea (excessive drooling), Supplemental Biologics License Application (sBLA)

The FDA approved Merz Neurosciences’ supplemental Biologics License Application for Xeomin (incobotulinumtoxinA), a treatment for chronic drooling in adults with neurodegenerative diseases.

July 5, 2018/by BioSpace

FDA Gives Genentech’s Tecentriq Priority Review for Triple-Combo Lung Cancer Treatment

Blockbusters, Chemotherapy, FDA/Regulatory, Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC), PD-1/PD-L1 inhibitors, Priority Review, Supplemental Biologics License Application (sBLA)

The FDA granted Genentech’s Tecentriq triple combination with Avastain, paclitaxel and carboplatin Priority Review for the first-line treatment of patients with metastatic NSCLC.

May 7, 2018/by BioSpace