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 ...

Read more →

UK MHRA grants GenSight Biologics’ Lumevoq ophthalmic gene therapy Promising Innovative Medicine Designation

6 September 2021 - GenSight Biologics today announced that its gene therapy Lumevoq has been granted Promising Innovative Medicine designation by ...

Read more →

EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty

6 September 2021 - EMA has started evaluating an application for the use of a booster dose of Comirnaty to be ...

Read more →

Leap forward for patients accessing medicines

7 September 2021 - Medicines Australia has secured a 5 year strategic agreement with the Federal Government, centered on earlier ...

Read more →

Health economic assessment of Sarclisa in multiple myeloma

6 September 2021 - TLV has produced a health economic assessment for the regions for the drug Sarclisa (isatuximab) in combination ...

Read more →

Democrats’ plans to introduce prescription drug pricing reform face formidable obstacles

6 September 2021 - For years, reducing prescription drug prices has been a policy goal of (mostly Democratic) legislators at the ...

Read more →

Congress “concerned by apparent anomalies” around FDA’s approval of Aduhelm

6 September 2021 - Congress demands more information from the FDA on its controversial approval of Biogen’s Alzheimer’s drug and its ...

Read more →

Statement on Moderna COVID-19 vaccine

6 September 2021 - Medicines Australia welcomes the TGA provisional approval for the COVID-19 vaccine, Spikevax (Moderna) for Australia. The ...

Read more →

Four million Pfizer doses arrive to super-charge vaccine roll out

6 September 2021 - Four million extra Pfizer-BioNTech (Pfizer) vaccine doses will begin arriving in Australia in days following a historic ...

Read more →

New treatment option for schizophrenia Reagila listed on PBS

6 September 2021 - Adults living with schizophrenia will have access to a new treatment option with Reagila (cariprazine), reimbursed ...

Read more →

New Zealand’s tocilizumab supply to be paused

6 September 2021 - PHARMAC has today announced that Roche, the global pharmaceutical company which provides tocilizumab, will not provide New ...

Read more →

CStone announces China's NMPA has accepted its new drug application for sugemalimab in the treatment of stage III NSCLC

2 September 2021 - Sugemalimab becomes the world’s first anti-PD-1/PD-L1 monoclonal antibody to significantly improve progression-free survival in patients with stage ...

Read more →

America desperately needs a much better FDA

2 September 2021 - In the early 1960s, an unflappable FDA scientist named Frances Kelsey spared the nation from the horrors ...

Read more →

Moderna announces submission of data to European Medicines Agency for its COVID-19 vaccine booster

3 September 2021 - mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40 times against ...

Read more →

GSK’s shingles vaccine Shingrix gains UK license

2 September 2021 - GlaxoSmithKline's Shingrix has been licensed in the UK for the prevention of shingles in adults aged ...

Read more →

COVID-19 vaccine: Spikevax (elasomeran)

4 September 2021 - On 3 September 2021, the TGA granted provisional approval to Moderna Australia for the use of ...

Read more →