Biosimilar approval and adoption in the U.S. needs to be expedited

20 March 2019 - Generic versions of brand-name small-molecule drugs saved Americans more than $1 trillion between 1999 and 2010. ...

Read more →

The shadow of Brexit on speed of access

20 March 2019 - No-one can miss the ongoing saga that is the UK’s exit from the European Union.  ...

Read more →

Karyopharm announces FDA extension of review period for selinexor new drug application

14 March 2019 - PDUFA action date extended by three months to July 6, 2019. ...

Read more →

One in four cancer patients wait two months for treatment, as NHS performance hits record low

14 March 2019 - The number of cancer sufferers waiting at least two months for treatment after an urgent referral ...

Read more →

Bavarian Nordic announces FDA delay in the review of the biologics license application for MVA-BN smallpox vaccine

11 March 2019 - Bavarian Nordic today announced that it has received information from the U.S. FDA that the review ...

Read more →

Senators tell FDA to speed up approvals of generic insulin

1 March 2019 - A bipartisan group of senators want the Food and Drug Administration (FDA) to change its policy ...

Read more →

Choosing a time horizon in cost and cost-effectiveness analyses

21 February 2019 - When designing a comparative outcomes or a cost-effectiveness analysis, the time horizon defining the duration of time ...

Read more →

Incyte announces U.S. FDA has extended the review period for ruxolitinib (Jakafi) in acute graft-versus-host disease

7 February 2019 - Incyte announced today that the U.S. FDA has extended the review period for the supplemental new ...

Read more →

Statement from FDA Commissioner on 2019 efforts to advance the development of complex generics to improve patient access to medicines

30 January 2019 - As part of the FDA’s efforts to promote drug competition and patient access, we’ve advanced many ...

Read more →

Shutdown risks delaying FDA approval of potentially life-saving drugs and therapies

22 January 2019 - It's not accepting new applications or fees during the shutdown. ...

Read more →

FDA chief Scott Gottlieb warns 'we have many hard decisions ahead of us' if government shutdown persists

18 January 2019 - "We are in uncharted territory. This is a watershed moment in the life of this agency," he ...

Read more →

FDA review of Aimmune drug put on hold due to government shutdown

14 January 2019 - The ongoing partial shutdown of the U.S. government has temporarily derailed biotech Aimmune Therapeutics' bid to win ...

Read more →

The FDA has five weeks till money runs out for approving new drugs

16 January 2019 - The US FDA has roughly five weeks of funding left to review new drug applications during ...

Read more →

If the shutdown drags on at FDA, it will put anticipated new treatments in jeopardy

14 January 2019 - The government shutdown could soon jeopardise highly anticipated new drugs from Janssen, Sanofi, and Novartis for ...

Read more →

How a 'regulatory dead zone' may be holding up copycat insulin

14 January 2019 - The insulin market has increasingly attracted scrutiny from politicians, regulators and patient groups, as prices ramp ...

Read more →