Alexion Pharmaceuticals, Inc. announced that the US Food and Drug Administration has approved Alexion's Rhode Island manufacturing facility in Smithfield, Rhode Island as a second source of commercial supply for Soliris. Earlier this year, Alexion reported that the European Medicines Agency had approved ARIMF as a second source of supply for Soli
Pharmaceutical company Forest Laboratories Inc revealed on Tuesday that a US Food and Drug Administration advisory committee has recommended approval of the companyEURs ceftaroline fosamil for the treatment of community acquired bacterial pneumonia and complicated skin and skin structure infections.
The US Food and Drug Administration approved Tekamlo tablets, a single-pill for the treatment of high blood pressure combining the only approved direct renin inhibitor, Tekturna, with the widely used calcium channel blocker amlodipine.
Palomar Medical Technologies, Inc. is skyrocketing on news it received FDA approval for its powered laser surgical instrument with microbeam\fractional output. Here is the link to the FDA approval. Shares of PMTI are higher by 4.7% today.
Perrigo Company announced it received FDA approval from the U.S. Food and Drug Administration to manufacture and market Imiquimod Cream, 5%. Perrigo will vertically integrate this product with their own API.
ALLEGAN, Mich., Sept. 8 Perrigo Company announced it received FDA approval from the U.S. Food and Drug Administration to manufacture and market Imiquimod Cream, 5%. Perrigo will vertically integrate this product with their own API.
ALLEGAN, Mich. Aldara, made by Graceway Pharmaceuticals, is also used for superficial basal cell carcinoma and external genital and perianal warts in patients 12 years old or older. In addition to making pharmaceutical products, Perrigo, which is based in Allegan, Mich., makes infant formulas, nutritional products and pharmaceutical and medical dia
Tekmira Pharmaceuticals, a Canadian biopharmaceutical company, has announced that its investigational new drug application for TKM-PLK1 has been cleared by the FDA allowing the company to initiate a Phase I human clinical trial. TKM-PLK1 is being developed as a treatment for patients with advanced solid tumor cancers who are not well served by curr
Teleflex, a provider of medical technology products, has received 510 market clearance from the FDA for its ArrowEVOLUTION PICC with Chlorag+ard technology, a peripherally inserted central catheter with a chlorhexedine-based solution that has been chemically-bonded into the surface of the catheter both intra- and extralumenally.
Pharmaceutical company Watson Pharmaceuticals Inc reported on Tuesday that its subsidiary, Watson Laboratories Inc, has received US approval for its generic equivalent to BayerEURs Yasmin oral contraceptive tablet. The US Food and Drug Administration has approved WatsonEURs Abbreviated New Drug Application for Zarah 3 mg/0.03 mg and the company
Watson Pharmaceuticals, a specialty pharmaceutical company, has announced that its subsidiary, Watson Laboratories, has received approval from the FDA for its abbreviated new drug application for Zarah 3mg/0.03mg, the generic equivalent to Bayer's Yasmin. Watson has begun shipping the product.
IRIS International, Inc., a leading manufacturer of automated in-vitro diagnostic systems and consumables for use in hospitals and commercial laboratories worldwide and provider of high value personalized diagnostics testing services through its CLIA certified molecular diagnostics laboratory, today announced that it has received 510 clearance from
09/07/10 Tekmira Pharmaceuticals Corporation, a leader in RNA interference therapeutics, today announced that its Investigational New Drug application for TKM-PLK1 has been cleared by the United States Food and Drug Administration allowing Tekmira to initiate a Phase 1 human clinical trial.
Teleflex Incorporated today announced that it has received 510 market clearance from the U.S. Food and Drug Administration for the company's ArrowEVOLUTION PICC with Chlorag+ard technology, a peripherally inserted central catheter with a Chlorhexedine-based solution that has been chemically-bonded into the surface of the catheter both intra- and ex
Watson Pharmaceuticals, Inc., today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Zarah 3 mg/0.03 mg, the generic equivalent to Bayer's Yasmin. Watson has begun shipping the product.
Ascension Orthopedics, a developer of PyroCarbon orthopedic devices, has received FDA approval to market the Titan modular total shoulder system. According to the company, the Titan modular total shoulder system offers a bone-preserving option for patients needing total or hemi shoulder arthroplasty.
CSL Behring announced that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application to extend the shelf life of Hizentra, Immune Globulin Subcutaneous, 20% Liquid, from 18 months to 24 months. Stabilized with L-proline, a naturally occurring amino acid, Hizentra can be stored at room temperature for up to 24
GlaxoSmithKline and Human Genome Sciences announce FDA priority review designation for Benlysta belimumab as a potential treatment for systemic lupus erythematosus.
Human Genome Sciences and GlaxoSmithKline Announce FDA Priority Review Designation for BENLYSTA belimumab as a Potential Treatment for Systemic Lupus Erythematosus. Human Genome Sciences, Inc. and GlaxoSmithKline PLC announced that the U.S. Food and Drug Administration has granted a priority review designation to BENLYSTA as a potential treatme
Abbott, a healthcare company engaged in the discovery, development, manufacture and marketing of pharmaceuticals and medical products, has received approval from the US Food and Drug Administration, or FDA, to market the Abbott RealTime HBV assay for measuring viral load or the amount of hepatitis B virus, or HBV, in a patient's blood.
AUSTIN, Texas, Sept. 2 Ascension Orthopedics, Inc., the world leader in PyroCarbon orthopedic devices, announces FDA approval to market the TITAN Modular Total Shoulder System.
September 2, 2010 Unilife Corp. said that its Unitract Tuberculin Syringe has received 510 market clearance from the U.S. Food and Drug Administration. The Unitract range is designed to allow operators to control the speed of passive needle retraction directly from the patient's body into the barrel of the syringe where it is locked in place.
InfraReDx, a medical device company, has received 510k clearance from the US Food and Drug Administration, or FDA, to market the LipiScan IVUS coronary imaging system.
SQI Diagnostics Inc., a medical systems automation company focused on evolving laboratory-based biomarker testing, announced today that the United States Food and Drug Administration has received the Company's 510 submission seeking marketing clearance in the U.S. for SQI's IgX PLEX Celiac Assay and automated SQiDworks Diagnostics Platform.
Unilife, a US-based medical device company, has announced that its Unitract Tuberculin, or TB, syringe has received 510k market clearance from the US Food and Drug Administration, or FDA. According to the company, the Unitract TB syringe is a variant of the Unitract 1ml insulin syringe for which Unilife secured FDA clearance earlier in 2010.
