Accelerated assessment of medical devices - priority review pathway

19 June 2017 - The TGA sought comments from interested parties on the consultation paper for accelerated assessment of medical devices ...

Read more →

Expedited pathways for prescription medicines

17 March 2017 - The TGA would like to thank respondents who provided submissions in response to the October 2016 ...

Read more →

Alnylam receives European Medicines Agency PRIME designation for accelerated assessment of givosiran, an investigational RNAi therapeutic for the treatment of acute hepatic porphyrias

1 March 2017 - Alnylam Pharmaceuticals announced today that the EMA has granted access to its Priority Medicines (PRIME) scheme ...

Read more →

European Medicines Agency grants accelerated assessment, validates marketing authorisation application for AbbVie's investigational regimen of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C in all major genotypes

24 January 2017 - Marketing authorisation application is supported by data from global registrational clinical development program across all major ...

Read more →

UK Government publishes findings of Accelerated Access Review

24 October 2016 - The UK government has now published long-awaited findings of the independent Accelerated Access Review, which strives ...

Read more →

Recommendations on eligibility to PRIME scheme

21 September 2016 - During its September 2016 meeting, the CHMP reviewed 9 recommendations for eligibility to PRIME: 2 were ...

Read more →

MHRA publishes EAMS scientific opinion on venetoclax for the treatment of chronic lymphocytic leukaemia

23 August 2016 - The MHRA has published its EAMS scientific opinion on venetoclax for the treatment of adults with ...

Read more →

MHRA EAMS scientific opinion: pembrolizumab for non-small cell lung cancer

23 August 2016 - The MHRA has published EAMS scientific opinion on the use of pembrolizumab for metastatic non-small-cell lung ...

Read more →

BioMarin announces EMA grants accelerated assessment for cerliponase alfa, experimental treatment for a form of Batten disease

3 May 2016 - BioMarin today announced that the EMA has granted BioMarin's request for accelerated assessment for the planned cerliponase ...

Read more →

New treatment for patients with multiple myeloma

1 April 2016 - The EMA has recommended granting a conditional marketing authorisation for Darzalex (daratumumab) for the treatment of adults ...

Read more →

EMA fast-tracks treatment of multiple myeloma for approval in EU

29 January 2016 - Empliciti is a monoclonal antibody that works by activating the body’s immune system to attack and kill ...

Read more →

From our perspective: Expedited oncology drug approvals

19 January 2016 - Richard Pazdur, M.D., Director of the FDA's Office of Hematology and Oncology Products, highlights some of his ...

Read more →