Cancer patients, advocates 'gobsmacked' PHARMAC declining funding application for life-changing drug

29 July 2021 - Ovarian cancer patients and advocates are "utterly gobsmacked" Pharmac has proposed to decline a funding application ...

Read more →

2021 October price disclosure cycle – indicative prices

30 August 2021 - Indicative 1 October 2021 prices resulting from the 2021 October Cycle of Price Disclosure have now ...

Read more →

GSK announces FDA approval for Nucala (mepolizumab) for use in adults with chronic rhinosinusitis with nasal polyps

29 July 2021 - First IL-5 therapy approved as an add-on treatment in the US for adults with chronic rhinosinusitis with ...

Read more →

Erytech granted U.S. FDA fast track designation for Eryaspase in hypersensitive ALL

29 July 2021 - Fast track designation for eryaspase underscores the need for new treatment options for patients who developed ...

Read more →

Announcement of the National Medicines Policy Review Committee and Terms of Reference

30 August 2021 -  The Minister for Health has established an Expert Advisory Committee to lead the Review of the National ...

Read more →

Ardelyx receives complete response letter from U.S. FDA for new drug application for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis

29 July 2021 - Ardelyx today announced that it has received a complete response letter from the U.S. FDA regarding ...

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 approves expanded Botox (onabotulinumtoxinA) label to include eight new muscles to treat adults with upper limb spasticity

29 July 2021 - Botox has demonstrated efficacy and has an established safety profile with over 10 years of clinical ...

Read more →

Biofourmis earns FDA's first ever breakthrough device designation for a novel digital therapeutic for heart failure

29 July 2021 - BiovitalsHF approved for expedited FDA review process as a first-in-class digital therapeutic for heart failure that augments ...

Read more →

Arrowhead Pharmaceuticals receives breakthrough therapy designation from U.S. FDA for ARO-AAT for the treatment of alfa-1 anti-trypsin deficiency associated liver disease

29 July 2021 - Full enrollment reached in Phase 2 SEQUOIA study of ARO-AAT. ...

Read more →

Advanz and private equity groups fined for 1,000 per cent drug price hike

29 July 2021 - Regulator penalises pharma company and buyout firms Cinven and Hg after NHS hit by ‘unfair’ rises. ...

Read more →

FDA accepts application for Genentech’s faricimab for the treatment of wet age-related macular degeneration and diabetic macular oedema

28 July 2021 - Across four Phase 3 studies, approximately half of patients receiving faricimab could extend treatment time to every ...

Read more →

COVID-19 vaccine weekly safety report (29 July 2021)

29 July 2021 - Over the last week, six additional cases of blood clots with low blood platelets have been assessed ...

Read more →

FDA authorizes baricitinib alone as treatment for COVID-19

28 July 2021 - Today, the U.S. FDA revised the Emergency Use Authorisation for baricitinib (Olumiant) now authorising baricitinib alone for ...

Read more →