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Roche Receives FDA Approval for Fourth-Generation HIV Combination Antigen-Antibody Assay americanpharmaceuticalreview
June 27, 2017
Roche announced its fourth-generation HIV combination antigen-antibody assay, the Elecsys HIV combi PT assay, has received FDA PMA approval from the U.S. Food and Drug Administration (FDA).
RITUXAN HYCELA approved by FDA for subcutaneous injection in certain blood cancers biospectrumasia
June 26, 2017
Treatment can be administered in five to seven minutes, compared to 1.5 hours or more for intravenous Rituxan
FDA approves Rituxan Hycela (rituximab and hyaluronidase human) for subcutaneous injection in certai worldpharmanews
June 26, 2017
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) approved Rituxan Hycela™ (rituximab and hyaluronidase human) for subcutaneous (under the skin) injection...
FDA accepts application for generic version of Advair Diskus europeanpharmaceuticalreview
June 26, 2017
The FDA has accepted Sandoz’s New Drug Application for fluticasone propionate / salmeterol combination product, a generic version of Advair Diskus…
Pfizer’s biosimilar gets a second knock-back from FDA pharmafile
June 26, 2017
Pfizer’s biosimilar gets a second knock-back from FDA
Novartis lung cancer combo receives FDA approval pharmafile
June 23, 2017
Novartis has revealed that its drug Tafinlar (dabrafenib) has received approval from the FDA for use in combination with Mekinist (trametinib) in the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours express the BRAF V
FDA accepts Amgen's sBLA to expand indication for Xgeva to include multiple myeloma patients cphi-online
June 23, 2017
Xgeva is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumours and is the number one prescribed agent by oncologists for this indication in the US.
FDA updates on Pfizer drug shortages cphi-online
June 23, 2017
Pfizer says shortages caused by manufacturing, distribution and third party delays.
FDA Accepts Amgen's Supplemental Biologics License Application to Expand Indication for Xgeva to Inc americanpharmaceuticalreview
June 22, 2017
Amgen announced the U.S. Food and Drug Administration (FDA) has accepted the Xgeva (denosumab) supplemental Biologics License Application (sBLA) that seeks to expand the currently approved indication for the prevention of fractures and other skeletal-rela
Victoza Receives Positive Vote from FDA Advisory Committee americanpharmaceuticalreview
June 22, 2017
Novo Nordisk announced the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) has completed its meeting regarding the supplemental New Drug Application (sNDA) for ...

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