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Latest FDA Stories

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...

2014-10-17 08:25:33

BGASoft, a global leader in the development industry has once again left their competitors in the dust. The introduction of BGASoft's new AGILEPART11 is like no other on the market today, and will make using AGILE process while maintaining 21CFR Part 11 compliance a snap for FDA regulated companies. FORT LAUDERDALE, Fla., Oct. 17, 2014 /PRNewswire/ -- BGASoft, a global leader in the development industry has once again left their competitors in the dust. The introduction of BGASoft's...

2014-10-16 23:12:37

On October 10, the FDA announced that the ICU Medical ConMed Stat2 Flow Controller is recalled because it was assembled with the wrong internal component. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) October 16, 2014 AttorneyOne.com, a recognized authority on law, updates the website daily regarding all the latest information from the FDA on Stat2 Flow Controller. The FDA...

2014-10-16 12:29:19

FLINT, Mich., Oct. 16, 2014 /PRNewswire/ -- Diplomat, the nation's largest independent specialty pharmacy, announced today that it has a contract to distribute Esbriet (pirfenidone), which was approved Oct. 15, 2014 by the U.S. Food and Drug Administration for the treatment of idiopathic pulmonary fibrosis. In addition to the breakthrough therapy designation, Esbriet was also granted the orphan drug designation and received priority review....

2014-10-15 23:11:30

On October 10, the FDA announced that several lots of CareFusion 203, EnVe and ReVel ventilators are recalled due to power connection failure. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) October 15, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on EnVe and ReVel ventilators. The US FDA announced on...

2014-10-15 23:02:20

The Firm is evaluating potential morcellator lawsuits on behalf of women who allegedly experienced the spread of uterine sarcoma and other cancers due to the use of power morcellators in laparoscopic hysterectomy and fibroid removal. New York, NY (PRWEB) October 15, 2014 Federal health regulators investigating the potential link between the use of power morcellators (http://www.injurybeacon.com/power-morcellator/) and the spread of undiagnosed uterine sarcoma and other cancers are not...


Word of the Day
ambsace
  • Bad luck; misfortune.
  • The smallest amount possible or the most worthless thing.
The word 'ambsace' comes from a Latin word meaning 'both'.