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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.
Indian pharma: Driving excellence in quality and patient centricity expresspharma
December 04, 2020
The Indian pharma industry has recorded tremendous growth over the decades, more so during the pandemic. The Indian pharma sector has continued to be one of the key stakeholders in the pharma supply chain, providing access to affordable and quality ...
Roche's Xolair gets US nod for nasal polyps treatment pharmatimes
December 03, 2020
Roche’s asthma med Xolair has scored approval from the US Food and Drug Administration (FDA) for the treatment of nasal polyps in adults.

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