LDR has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Avenue L Lateral Lumber Cage system, which is implanted via a direct lateral trans-psoatic approach for lateral lumbar fusion. Avenue Lumber Cage ...
Tags: LDR, 510(k)approval, FDA, Avenue Lumber Cage system, lateral lumbar fusion
Integra LifeSciences, a provider of orthopedic devices, has launched IPP-ON PIP Fusion system for the treatment of hammertoe deformity. The IPP-ON PIP system, a one-piece, stainless steel interphalangeal fusion device, is indicated for ...
Tags: Integra LifeSciences, IPP-ON PIP Fusion system, treatment
Multinational biopharmaceutical company Celgene has received US Food and Drug Administration (FDA) approval for Abraxane, which is aimed to treat locally advanced or metastatic non-small cell lung cancer in combination with carboplatin in ...
Tags: Abraxane, lung cancer, Multinational biopharmaceutical company Celgene
Several lawsuits filed across the US claim orange juice made by Tropicana is not that 'natural' as the labels mention, but existing regulations do not specify exactly what constitutes natural. A statement from the juice maker says it is ...
Tags: Orange Juice Labeling, Labeling, Tropicana
GlaxoSmithKline (GSK), Ligand Pharmaceuticals' partner, has gained FDA priority review status for the supplemental new drug application for Promacta to treat thrombocytopenia in adult patients with chronic hepatitis C virus infection. ...
Tags: GlaxoSmithKline, GSK, promacta, thrombocytopenia
Glenmark Generics, a US subsidiary of Glenmark Pharmaceuticals, has received final FDA approval for its abbreviated new drug application for Norgestimate and Ethinyl Estradiol tablets USP 0.25mg/0.035mg. The product is the generic version ...
Spinal Restoration has completed enrolling patients in its Phase III Investigational new drug (IND) study of the Biostat System. The Biostat System, which comprises a human derived, resorbable Biostat Biologx Fibrin Sealant, features the ...
Tags: Spinal Restoration, IND study, Biostat System, study success
US based Ariad Pharmaceuticals has submitted New Drug Application (NDA) for its investigational BCR-ABL inhibitor, ponatinib for the approval of US Food and Drug Administration (FDA). Ponatinib is indicated for patients with resistant or ...
Tags: BCR-ABL inhibitor, CML, Ph+ALL
Novartis, Incyte's strategic collaborator, has received the European Commission approval for Jakavi (INC424, ruxolitinib), an oral JAK 1 and JAK 2 inhibitor to treat patients with myelofibrosis. The oral JAK 1 and JAK 2 inhibitor ...
CSL Behring has received FDA orphan drug designation for its recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP). The designation was granted for the treatment and prophylaxis of bleeding episodes in ...
Tags: CSL Behring, rIX-FP, hemophilia B
Threshold Pharmaceutical has received orphan drug designation for TH-302, a cancer drug, from the US FDA. Threshold is presently testing TH-302 along with a commonly used chemotherapeutic agent, doxorubicin, in a late-stage trial to treat ...
Horizon Pharma RAYOS (prednisone) delayed-release tablets have received the US Food and Drug Administration (FDA) approval. The approved drug is used to treat rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis ...
Tags: Horizon Pharma RAYOS delayed-release tablets, rheumatoid arthritis, RA
The US Food and Drug Administration (FDA) has granted approval to Lupin Pharmaceuticals to market a generic version of CP Pharmaceuticals' Lyrica (Pregabalin) capsules. Lupin's generic equivalent of Lyrica capsules are manufactured as ...
Tags: FDA, Lupin Pharmaceuticals, lyrica capsules
Kl ckner Pentaplast has announced the extension of its PentaformSmartCycle film product line to include Pentaform SmartCycle PET films comprising 100% post-consumerrecycled (PCR) content. According to the German packaging films producer, ...
Kelyniam Global has registered craniofacial implant's 510(k) application with the US Food and Drug Administration (FDA). Craniofacial implant, made of Invibio PEEK Optima material, is designed for the treatment of patients with congenital ...
Tags: Kelyniam, FDA, craniofacial implant's 510(k)application