• Facebook
  • Twitter
  • LinkedIn
  • Google +
  • RSS

Food and Drug Administration (FDA) - Articles and news items

Wickham Labs logo

Wickham Labs to Exhibit at Pharmig 2016

Supplier news / 3 November 2016 / Wickham Laboratories Limited

Wickham Laboratories will be on Stand 8 at the 24th Annual Pharmig Conference in the Nottingham Belfry Hotel, November 16th & 17th…

wll-logo-feature-image

Wickham Laboratories Announces Renewal of FDA Accreditation

Supplier news / 20 October 2016 / Wickham Laboratories

Wickham Laboratories reports a successful completion of the FDA auditing process with renewal of GMP accreditation….

cerament g bone substitute

FDA approves IDE study for bone graft substitute, Cerament G

Industry news / 10 August 2016 / Niamh Louise Marriott, Digital Content Producer

Bonesupport’s Fortify study will evaluate the safety and efficacy of Cerament G as part of surgical repair of open diaphyseal tibial fractures. The trial will enrol up to 230 patients at up to 30 centres globally, with the aim of having at least 50% of the study data coming from US subjects…

FDA grants fast track for Shire’s NASH investigational treatment

FDA grants fast track for Shire’s NASH investigational treatment

Industry news / 29 July 2016 / Mandy Parrett, Editorial Assistant

Shire Plc has announced today that the United States Food and Drug Administration (FDA) has granted Fast Track designation for SHP626 (volixibat) for an investigational treatment of adults with nonalcoholic steatohepatitis (NASH) with liver fibrosis.

Hepatitis C

Hepatitis C: commitment to a cure

Blog, Z Homepage promo / 28 July 2016 / Niamh Louise Marriott, Digital Content Producer

To find out more about Hepititis C, European Pharmaceutical Review spoke with Raquel Peck, CEO of the World Hepatitis Alliance and discovered exactly what it is being done to combat this widespread global health issue…

grazoprevir/elbasvir

AbbVie receives FDA approval for new Hepatitis C drug

Industry news / 27 July 2016 / Niamh Louise Marriott, Digital Content Producer

US FDA has approved Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the treatment of chronic genotype 1 (GT1) hepatitis C…

IV C difficile treatment

FDA grants QIDP for C. Difficile IV treatment

Industry news / 25 July 2016 / Niamh Louise Marriott, Digital Content Producer

Morphochem announced today that the U.S. FDA has designated Morphochem’s intravenous antibacterial product as a Qualified Infectious Disease Product…

namzaric

FDA approves expanded label for Namzaric in Alzheimer’s disease

Industry news / 20 July 2016 / Victoria White, Digital Content Producer

Namzaric is a fixed-dose combination of memantine hydrochloride, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor…

biosimilar-etanercept

FDA committee recommends approval of Sandoz’s biosimilar etanercept

Industry news / 14 July 2016 / Victoria White, Digital Content Producer

The Arthritis Advisory Committee voted unanimously in support of biosimilar etanercept for all five indications of the reference product…

chewable mebendazole

FDA grants priority review to Janssen’s chewable mebendazole

Industry news / 14 July 2016 / Victoria White, Digital Content Producer

If approved, chewable mebendazole will provide a treatment and prevention alternative for adults and children with soil-transmitted helminthiasis…

prevnar 13

FDA approves label expansion for Pfizer’s Prevnar 13

Industry news / 13 July 2016 / Victoria White, Digital Content Producer

Prevnar 13 is now approved for adults 18 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by S. pneumoniae…

xiidra

FDA approves Shire’s Xiidra for dry eye disease

Industry news / 12 July 2016 / Victoria White, Digital Content Producer

With this approval, Xiidra is the only prescription eye drop indicated for the treatment of both signs and symptoms of this condition…

 

Webinar: Use of MicroNIR to optimise fluid bed drying and to reduce waste at tablet compressionFIND OUT MORE
+ +