You are here: Industry Insights > FDA

News List

FDA Approves Subcutaneous C1 Esterase Inhibitor to Treat Rare Genetic Disease americanpharmaceuticalreview
June 27, 2017
The U.S. Food and Drug Administration approved Haegarda, the first C1 Esterase Inhibitor for subcutaneous administration to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients.
FDA Grants Conatus Orphan Drug Designation for IDN-7314 americanpharmaceuticalreview
June 27, 2017
Conatus Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Conatus' drug candidate IDN-7314 for the treatment of primary sclerosing cholangitis (PSC), a disease affecting bile ducts in the liver wh
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.

Previous page 1 2 3 4 5 6 7 8 9 10 ... 366 367 Next page