You are here: Industry Insights > FDA

News List

Pfizer’s biosimilar gets another FDA rejection biospectrumasia
June 28, 2017
FDA complete response letter (CRL) cited concerns about the same Pfizer fill-finish plant whose problems led the FDA to deny approval of a highly anticipated copy of Teva’s Copaxone that was to be finished there.
FDA approves 510(k) clearance to Ortho’s VITROS Insulin reagent and Calibrators biospectrumasia
June 28, 2017
An important biomarker in diabetes and pre-diabetes testing, the assay is expected to be commercially available for use on all of Ortho's VITROS Immunodiagnostic and Integrated Systems in the U.S. during the third quarter of this year.
FDA approves cryopreserved formulation of ReNeuron’s candidate europeanpharmaceuticalreview
June 28, 2017
The FDA has approved the cryopreserved formulation of ReNeuron’s human retinal progenitor cell (hRPC) therapeutic candidate…
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

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