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Latest FDA Stories

2014-10-21 16:28:41

First-Ever Product Submission for LAL Deficiency LEXINGTON, Mass., Oct. 21, 2014 /PRNewswire/ -- Synageva BioPharma Corp. (Synageva) (NASDAQ: GEVA), a biopharmaceutical company developing therapeutic products for rare disorders, announced today the start of a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for sebelipase alfa as a treatment for patients with lysosomal acid lipase deficiency (LAL Deficiency), a rare genetic...

2014-10-21 08:34:57

World's First 32-contact SCS Surgical Leads Designed to Provide More Focused Pain Relief for Patients with Chronic Pain MARLBOROUGH, Mass., Oct. 21, 2014 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) and CE Mark approval for the CoverEdge(TM) 32 and CoverEdge(TM) X 32 Surgical Leads, the world's first 32-contact surgical leads designed to blanket the spinal cord for unprecedented pain coverage. Designed for use with...

2014-10-21 08:33:47

- Label expansion to broaden patient base who may benefit from nonsurgical collagenase therapy LYNBROOK, N.Y., Oct. 21, 2014 /PRNewswire/ -- BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX(®) (collagenase clostridium histolyticum or CCH) in the U.S. and XIAPEX(®) in the EU, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics...

2014-10-21 08:33:30

Universal needle-free reconstitution and transfer system now available for use in hospitals EXTON, Pa., Oct. 21, 2014 /PRNewswire/ -- West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, has received 510(k) clearance of the Vial2Bag® DC device from the United States Food and Drug Administration, and also the CE Mark for the European Union. http://photos.prnewswire.com/prnvar/20131029/NE05658LOGO The Vial2Bag...

2014-10-20 23:09:15

On October 10, the FDA advised consumers not to purchase or use Sit and Slim II due to hidden drug ingredients. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) October 20, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Sit and Slim II. The FDA advised consumers on October 10 not to purchase or use Sit...

2014-10-20 16:27:09

- Biologics License Application (BLA) for secukinumab, a "first-in-class" IL-17A inhibitor, is currently under FDA review with an anticipated action date in early 2015 EAST HANOVER, N.J., Oct. 20, 2014 /PRNewswire/ -- Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US Food and Drug Administration (FDA) today voted 7 to 0 to support the approval of AIN457 (secukinumab), a selective interleukin-17A (IL-17A) inhibitor, for the treatment...

2014-10-20 12:30:10

ROCKVILLE, Md., Oct. 20, 2014 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTC: RGRX) ("the Company" or "RegeneRx") today announced that it met with the FDA in September and as a result of the meeting may begin Phase 3 to evaluate RGN-259 preservative-free eye drops for the treatment of patients with neurotrophic keratopathy (NK), an orphan disease of the cornea. The Company believes clinical trials could be started by mid-2015. As is typically required by FDA, the Company is...

2014-10-20 08:32:12

Latest submission seeks approval for additional blood cancer indication RARITAN, N.J., Oct. 20, 2014 /PRNewswire/ -- Janssen Research & Development, LLC ("Janssen") today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA(®) (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its strategic partner Pharmacyclics, Inc. If approved, this latest regulatory submission will become the fourth indication for IMBRUVICA, adding the treatment of...

2014-10-17 23:07:09

On October 10, the FDA announced that certain unexpired human and veterinary sterile products by Oregon Compounding Centers, Inc. are recalled due to lack of sterility assurance. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) October 17, 2014 AttorneyOne.com, a recognized authority on law, updates the website daily regarding all the latest information from the FDA on sterile...

2014-10-17 16:24:18

BALTIMORE, Md., Oct. 17, 2014 /PRNewswire-USNewswire/ -- The following is being released by the Center for Medical Technology Policy: The Green Park Collaborative (GPC) will bring together representatives from the FDA, public and private payers, medical device and pharmaceutical companies, as well as patient representatives, clinicians, and other experts January 12, 2015 at its first ever workshop on the comparative effectiveness and value of weight loss treatments. Participants...


Word of the Day
abrosia
  • Wasting away as a result of abstinence from food.
The word 'abrosia' comes from a Greek roots meaning 'not' and 'eating'.