The US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) of Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company for Tradjenta (linagliptin) tablets for use as add-on therapy to insulin. ...
Tags: FDA, sNDA, pharmaceutical product, clinical development
The US Food and Drug Administration (FDA) has cleared CryoPen 's new GY2 Cryosurgical system for use in gynecology. The GY2 Cryosurgical system, which delivers treatment at -105° Celsius, facilitates medical professionals to ablate ...
Tags: GY2 Cryosurgical System, Health, gynecology
The US Food and Drug Administration (FDA) has granted orphan drug designation to GeNO for use of inhaled nitric oxide (NO) in treatment of persistant pulmonary hypertension of the newborn (PPHN). The orphan drug designation was granted ...
Tags: orphan drug designation, FDA, persistant pulmonary hypertension
Genentech, a member of Roche Group, has obtained clearance for its Lucentis 0.3 mg (ranibizumab injection) from the US Food and Drug Administration (FDA). Lucentis 0.3 mg is a recombinant humanized monoclonal antibody fragment (lacking an ...
Tags: Genentech, Lucentis 0.3 mg, Medicine, Injection
The US Food and Drug Administration (FDA) has granted final approval to Mylan Pharmaceuticals' abbreviated new drug application (ANDA) of Modafinil tablets USP,100 mg and 200 mg. Modafinil USP,100 mg and 200 mg tablets are generic ...
Ethicon Endo-Surgery has obtained 510(k) clearance for its new Harmonic ACE+ Shears with adaptive tissue technology from the US Food and Drug Administration (FDA). The Harmonic ACE+ Shears, which features a tapered, coated refined blade, ...
Tags: ACE, Ethicon Endo, tissue technology
The US Food and Drug Administration (FDA) has cleared Biologic Therapies' new Bio-MAC Bone Marrow Aspiration catheter, designed to simplify and safely harvest bone marrow. The Bio-MAC catheter, which contains growth factors and adult ...
Tags: FDA, Bio-MAC Bone Marrow Aspiration catheter, catheter
Menno Beachy,an establishment based in Iowa,US,is recalling one pint containers of Certified Organic Grape Tomatoes because they have the potential to be contaminated with Salmonella,according to the US Food and Drug Administration(FDA). ...
Tags: FDA, Salmonella, label
AspenBio Pharma has submitted its AppyScore blood-based test's pre-investigational device exemption (pre-IDE) to the US Food and Drug Administration (FDA). AppyScore blood-based test is designed to aid physicians in identifying children ...
Tags: pre-investigational device, pre-IDE device, AppyScore blood-based test
The US Food and Drug Administration (FDA) has cleared Toshiba America Medical Systems' 16-element flexible coil system, designed to improve MR exam efficiency and image quality. The new coil system, which is developed in collaboration ...
Tags: 16-Element Flexible Coil System, Coil System, Medical Systems
Mylan Institutional has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Etomidate Injection USP, 2 mg/mL packaged in 40 mg/20 mL single-use vials. The approved ...
Tags: Medicine, Etomidate Injection, Hospira's Amidate injection
The US Food and Drug Administration (FDA) has approved ZALTRAP (ziv-aflibercept) injection to be used in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI) to treat patients with metastatic colorectal cancer (mCRC) that is ...
Tags: Zaltrap Injection, Medicine
Sunshine Heart has obtained conditional approval for its new C-Pulse system driver from the US Food and Drug Administration (FDA). The new driver, which features a lighter single unit and a number of software enhancements, is designed to ...
Conventus Orthopaedic has completed patient enrollment in a clinical study of its Conventus DRS Implant. The minimally invasive implant uses Conventus DRS technology to stabilize the fractured bone fragments from within the bone and treat ...
Tags: Conventus DRS Implant, fractured bone fragments, clinical study
Benvenue Medical has completed enrolling patients in its Kiva System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial (KAST). Kiva system, which features a proprietary flexible Kiva implant, is designed to reduce ...
Tags: Kiva System, Safety and Effectiveness Trial, FDA, KAST Study