FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumour shrinkage

14 November 2019 - Today, the U.S. FDA granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients ...

Read more →

Fast-track drug approval, designed for emergencies, is now routine

5 July 2019 - Three-quarters of new drugs get an expedited regulatory review, thrusting families and doctors into a new world ...

Read more →

FDA's Woodcock defends accelerated approvals and talks of culture shift in clinical trials

5 June 2019 - Over more than three decades at the Food and Drug Administration, Janet Woodcock has seen the ...

Read more →

Assessment of the clinical benefit of cancer drugs receiving accelerated approval

28 May 2019 - When a cancer drug that has received accelerated approval from the US FDA is claimed to have ...

Read more →

Drug makers push back on data requirements in Australia’s provisional approval pathway

5 September 2017 - A who’s who of leading drug makers have raised concerns about the proposed data requirements for ...

Read more →

Provisional approval pathway for prescription medicines

1 September 2017 - The TGA would like to thank respondents who provided submissions in response to the March 2017 ...

Read more →

Flimsy evidence behind many FDA approvals

16 August 2017 - Many drugs granted accelerated approval by the U.S. FDA lack clear evidence of safety and effectiveness, ...

Read more →

Characteristics of pre-approval and post-approval studies for drugs granted accelerated approval by the US Food and Drug Administration

15 August 2017 - The FDA granted accelerated approval to 22 drugs for 24 indications.  ...

Read more →

Bristol-Myers Squibb receives accelerated approval of Opdivo (nivolumab) from the U.S. Food and Drug Administration

22 December 2014 - First approval of Opdivo in the United States. ...

Read more →

Major flaws in US drugs with 'accelerated' approval, research suggests

7 June 2017 - A new study published today has exposed major flaws in the fast tracking of some drugs ...

Read more →

FDA approves Merck’s Keytruda (pembrolizumab) for patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy

5 August 2016 - Merck today announced that the U.S. FDA has approved Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death ...

Read more →

Accelerated approval and expensive drugs — a challenging combination

24 May 2017 - For serious or life-threatening disease, the FDA can approve drugs on the basis of surrogate end points ...

Read more →

Accelerating development of scientific evidence for medical products within the existing US regulatory framework

1 May 2017 - Growing access to diverse 'real-world' data sources is enabling new approaches to close persistent evidence gaps about ...

Read more →

Takeda announces FDA accelerated approval of Alunbrig (brigatinib)

29 April 2017 - Alunbrig approved for ALK+ metastatic non-small-cell lung cancer patients who have progressed on or are intolerant ...

Read more →

FDA grants Roche’s Tecentriq (atezolizumab) accelerated approval as initial treatment for certain people with advanced bladder cancer

18 April 2017 - First and only cancer immunotherapy approved in advanced bladder cancer as initial treatment for those unable ...

Read more →