Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Archives

U.S. FDA Approves Streamlined Process for Initiating HIV Therapy with Cabenuva

Antiretrovirals, FDA/Regulatory, HIV-1, Injectables, Integrase strand transfer inhibitors, Janssen, Labeling Update, Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), Therapeutics, ViiV Healthcare

ViiV Healthcare and Janssen Pharmaceutical’s Cabenuva treatment for people living with human immunodeficiency virus (HIV-1) received a label update as adult patients now have the option to start the injectable regimen without the need for an oral lead-in period first.

Top 10 Pipelines To Watch: 2019 Annual Report

Analysts, Ankylosing Spondylitis (AS), Annual Reports, Antiretroviral Drugs, Atopic Dermatitis (Eczema), Autoimmune Diseases, B Cells, Big Pharma, Biologics, Biopharma, Biotechnology, Blockbusters, BRCA Gene, BRCA mutation, Breakthrough Therapy Designation, Business, Cancer, CAR-T Therapy, Cells, Chemotherapy, Clinical Data, Clinical Trials, Collaborations, Crohn's Disease, Cystic Fibrosis, Drug Discovery, EU, European Medicines Agency (EMA), Fast Track Designation, FDA, FDA/Regulatory, February 2019, Future Blockbusters, Gene Editing, Generalized Myasthenia Gravis (gMG), Genomics, HIV, Human Genome, Immune Cells, Immune System, Immune-Mediated Diseases, Immunotherapy, Inflammatory Diseases, Injectables, Innovation, Integrase strand transfer inhibitors, Issue Archives, Japan, M&A, Med Ad News, Monoclonal Antibodies, Multiple myeloma, Neoantigens, Neurology, Neuromyelitis Optica Spectrum Disorder (NMOSD), New Drug Applications, Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), Non-Small Cell Lung Cancer (NSCLC), Nonalcoholic Steatohepatitis (NASH), Nuclear Medicine, Oncology, Orphan Drug Designation, Paroxysmal Nocturnal Hemoglobinuria (PNH), Precision Medicine, Prescription Drug User Fee Act (PDUFA), Priority Medicines (PRIME) Designation, Priority Review Voucher, Product Pipelines, Proteins, Psoriatic Arthritis, R&D, Radioligands, Rare Disorders, Research, Rheumatoid Arthritis, RNA Interference (RNAi), Sickle Cell Disease, Small Molecules, Special Reports, T-Cells, Top 10 Pipelines, Top 10 Pipelines To Watch, Tumors, Ulcerative Colitis, Ultra Rare Diseases

The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.

U.S. FDA Accepts sNDAs for Pifeltro and Delstrigo

Antiretroviral Drugs, FDA, FDA/Regulatory, HIV, Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), Supplemental New Drug Application (sNDA)

Merck & Co. announced that the U.S. Food and Drug Administration accepted for review supplemental New Drug Applications (sNDAs) for Pifeltro and Delstrigo.