You are here: Industry Insights > FDA

News List

FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention americanpharmaceuticalreview
December 09, 2020
The U.S. Food and Drug Administration (FDA) expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza (flu) for patients 12 years of age and older after contact with an individual who has the flu.
Neurelis Completes Pre-IND Meeting with FDA for Acute Agitation Treatment americanpharmaceuticalreview
December 09, 2020
Neurelis has concluded a pre-Investigational New Drug (IND) Application meeting with the U.S. Food and Drug Administration (FDA) regarding NRL-4. The FDA provided direction for the clinical development pathway for the investigational treatment.
Janssen eyes US approval for EGFR-targeting NSCLC therapy pharmatimes
December 08, 2020
Janssen has submitted an application the US Food and Drug Administration (FDA) seeking approval for its non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 mutations therapy amivantamab.
FDA Approves Danyelza americanpharmaceuticalreview
December 08, 2020
The U.S. Food and Drug Administration (FDA) approved Danyelza (naxitamab-gqgk) for use in combination with granulocyte-macrophage colony-stimulating factor (GM¬-CSF) for the treatment of pediatric patients 1 year of age and older and adult patients ...
RedHill Biopharma Initiates Study of RHB-204 for NTM Disease americanpharmaceuticalreview
December 08, 2020
RedHill Biopharma has initiated its Phase 3 study to evaluate the safety and efficacy of RHB-204 as a potential first-line, stand-alone, oral treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex (MAC) ...
FDA Approves Zokinvy for Hutchinson-Gilford Progeria Syndrome americanpharmaceuticalreview
December 08, 2020
Eiger BioPharmaceuticals announced the U.S. Food and Drug Administration (FDA) has approved ZokinvyTM (lonafarnib) for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies (PL).
Roche gets FDA approval of Gavreto in advanced or metastatic RET-mutant and RET fusion-positive thyroid cancers pharmaceutical-business-review
December 07, 2020
Roche announced that the U.S. Food and Drug Administration (FDA) has approved Gavreto (pralsetinib) for the treatment of adult and paediatric patients 12 years of age and older with advanced or metastatic rearranged during transfection (RET)-mutant ...
FDA grants Fast Track designation to COVID-19 ARDS treatment europeanpharmaceuticalreview
December 04, 2020
The designation should expedite the review of remestemcel-L, a cellular therapy that has shown promise in treating acute respiratory distress syndrome (ARDS) in COVID-19 patients.
FDA approves Rhizen Pharmaceuticals’ application to study Covid-19 drug pharmaceutical-technology
December 04, 2020
The US Food and Drug Administration (FDA) has approved Rhizen Pharmaceuticals’ Investigational New Drug (IND) application to study its dihydroorotate dehydrogenase (DHOHD) inhibitor, RP7214, for SARS-CoV-2 infection.
Granules India gets US FDA approval for Penicillamine Capsules expresspharma
December 04, 2020
They are indicated in the treatment of Wilson's disease, cystinuria, and in patients with severe, active rheumatoid arthritis.

Previous page 1 2 3 4 5 6 7 8 9 10 ... 367 368 Next page