FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease

29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...

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PHARMAC publishes agenda for May 2022 PTAC meeting

12 May 2022 - Yet another PTAC meeting with very few applications for new medicines/medicines still under patent protection. ...

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Digital health devices must prove a benefit to get reimbursement

13 May 2022 - Digital health care companies should prove that their devices can improve the quality of patient care ...

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Hundreds of patients to get life-extending lung cancer drug on the NHS

13 May 2022 - Hundreds of people with a form of the most common form of lung cancer could survive ...

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Hansa Biopharma announces temporary marketing authorisation in Switzerland for Idefirix (imlifidase) in kidney transplantation

13 May 2022 - Idefirix is now granted marketing authorisation within the EU, the U.K., Israel and Switzerland. ...

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Health Canada accepts SNDS filing and grants priority review of oral edarvarone formulation for the treatment of ALS

13 May 2022 - Mitsubishi Tanabe Pharma Canada announced today that Health Canada has accepted the filing of a supplement to ...

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Bridgebio Pharma sells rare pediatric disease priority review voucher for $110 million

13 May 2022 - Entered into a definitive agreement to sell the rare paediatric disease priority review voucher it obtained in ...

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The man behind ‘value based pricing’ saw pharma distorting his message — and walked away

13 May 2022 - When Biogen announced the price for Aduhelm, its controversial Alzheimer’s drug, the explanation the company gave ...

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FDA approves novel, dual targeted treatment for type 2 diabetes

13 May 2022 - In clinical trials, treatment proved more effective than other therapies evaluated. ...

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PolarityTE announces FDA regenerative medicine advanced therapy designation granted to SkinTE

13 May 2022 - PolarityTE today announced that the U.S. FDA granted a regenerative medicine advanced therapy designation to SkinTE under ...

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Will the FDA change how it vets drugs following the Alzheimer's debacle?

13 May 2022 - The accelerated approval of aducanumab has triggered US law makers to push for more oversight from the ...

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NHS patients missing out on new medicines that could extend lives

13 May 2022 - Data shows that 1.2 million additional NHS patients are currently eligible for vital medicines but are ...

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Women with moderate to severe fibroids set to be offered new one a day treatment following final draft guidance from NICE

13 May 2022 - Around 4,500 women with uterine fibroids will be eligible for a new oral treatment after NICE recommended ...

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TGA commences evaluation of Moderna COVID-19 vaccine (Spikevax) for children aged 6 months to 5 years old

13 May 2022 - The TGA has received, and immediately commenced evaluation of, an application from Moderna to extend the ...

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Update on U.S. FDA review of biologics license application for bimekizumab

13 May 2022 - UCB announced today that the U.S. FDA has issued a complete response letter regarding the biologics ...

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TGA removes age limit for BBIBP-CorV (Sinopharm) COVID-19 vaccine recognition for international travel to Australia

13 May 2022 - The TGA has determined that the BBIBP-CorV (Sinopharm) COVID-19 vaccine will be 'recognised' for all ages for ...

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