Covid-19 delta outbreak: major PHARMAC review report delayed by lockdown

22 September 2021 - Act says it is "not good enough" an interim report for a much touted independent PHARMAC ...

Read more →

PDUFA goal date extension for Nefecon NDA in the U.S.

14 September 2021 - Calliditas Therapeutics today announced that the U.S. FDA has extended the PDUFA goal date for its  ...

Read more →

Patients in the Netherlands wait 1.5 years for access to new medicines

2 September 2021 - Patients in the Netherlands have to wait an average of 510 days for access to a new ...

Read more →

Axsome Therapeutics provides update on the new drug application for AXS-05 for the treatment of major depressive disorder

23 August 2021 - Axsome Therapeutics today announced that the U.S. FDA informed the Company in a teleconference on August 20, ...

Read more →

TGA reduces timeframe for publishing adverse event reports

19 August 2021 - With strong public interest in adverse event reports relating to COVID-19 vaccinations, and improvements in our ...

Read more →

Jason Falinski slams TGA’s slow Moderna Covid vaccine approval

10 August 2021 - The TGA took eight months to approve the Moderna Covid-19 vaccine in Australia despite its use in ...

Read more →

FDA reportedly hopes to fully approve Pfizer’s Covid vaccine by Labor Day

3 August 2021 - Federal regulators are aiming to grant full approval to Pfizer’s coronavirus vaccine by early September, the New ...

Read more →

The FDA finally gets moving on Pfizer

2 August 2021 - The agency will now ‘sprint’ to grant full vaccine approval. ...

Read more →

Congress presses the FDA to move faster on ALS drugs

29 July 2021 - Lawmakers pressed a top FDA official Thursday for answers on why the agency has balked at approving ...

Read more →

FDA says it's working as fast as possible to fully approve vaccines, as urgency rises amid COVID-19 surge

29 July 2021 - The US FDA insists it is working as quickly as possible to review applications for full ...

Read more →

FDA says its 'working as quickly as possible' to review for full approval of vaccines

27 July 2021 - Some say full approval could sway hesitant Americans to get the vaccine. ...

Read more →

TGA hopes to approve Moderna COVID-19 vaccine by early August

23 July 2021 - Therapeutic Goods Administration head John Skerritt said the Moderna vaccine looked promising, but he was still ...

Read more →

Pfizer provides update on U.S. FDA review of abrocitinib and Xeljanz filings

21 July 2021 - Pfizer announced today that the U.S. FDA has notified the company that it will not meet the ...

Read more →

Lilly and Incyte provide update on supplemental new drug application for baricitinib for the treatment of moderate to severe atopic dermatitis

16 July 2021 - Eli Lilly and Incyte announced today that the U.S. FDA will not meet the Prescription Drug User ...

Read more →

AbbVie provides update regarding Rinvoq (upadacitinib) for the treatment of moderate to severe atopic dermatitis in the U.S.

16 July 2021 - AbbVie today announced the U.S. FDA did not meet the Prescription Drug User Fee Act action ...

Read more →