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 →

Pfizer plans to request FDA approval for COVID booster shot in August

9 Jul 2021 - Pfizer plans to request US emergency authorisation in August for a third booster dose of its ...

Read more →

BeiGene announces acceptance of a supplemental biologics license application in China for tislelizumab in oesophageal squamous cell carcinoma

7 July 2021 - BeiGene today announced that the Center for Drug Evaluation of the China National Medical Products Administration ...

Read more →

Y-mAbs announces NMPA submission of BLA for Danyelza (naxitamab-gqgk) in China

6 July 2021 - Y-mAbs Therapeutics today announced that SciClone Pharmaceuticals has submitted the biologics license application for Danyelza (naxitamab-gqgk) for ...

Read more →

ATAGI update following weekly COVID-19 meeting – 7 July 2021

8 July 2021 - An update from the Australian Technical Advisory Group on Immunisation following their weekly meeting on 7 July ...

Read more →

House report: drug companies spent more on buybacks, dividends than research

8 July 2021 - House Democrats on Thursday released a report that found that the 14 leading drug companies paid ...

Read more →

Lysogene announces FDA fast track designation for LYS-GM101 gene therapy for the treatment of GM1 gangliosidosis

8 July 2021 - Lysogene today announced that the U.S. FDA has granted fast track designation to its LYS-GM101 program, which ...

Read more →

In a reversal, FDA calls for limits on who gets Alzheimer’s drug

8 July 2021 - The agency faced criticism for approving Aduhelm for all Alzheimer’s patients. The new label recommends that the ...

Read more →

COVID-19: flood of Pfizer doses finally here

8 July 2021 - Australia has clinched a potentially game-changing deal to triple its access to Pfizer Covid-19 vaccines to one ...

Read more →

FDA approves updated Aduhelm prescribing information to emphasise population studied in clinical trials

8 July 2021 - Aduhelm should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s ...

Read more →

Tezepelumab regulatory submission accepted and granted FDA priority review in the US for the treatment of patients with asthma

8 July 2021 - Tezepelumab is the first and only biologic to consistently and significantly reduce asthma exacerbations in a ...

Read more →

COVID-19 vaccine weekly safety report (8 July 2021)

8 July 2021 - Seven additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...

Read more →

Health Canada approves Vyxeos, the first chemotherapy advance in over 40 years for adults with high-risk acute myeloid leukaemia

7 July 2021 - Jazz Pharmaceuticals today announced the Health Canada approval and availability of Vyxeos (daunorubicin and cytarabine liposome for ...

Read more →

Hospitals often charge uninsured people the highest prices, new data show

6 July 2021 - Cash payers are often charged more than insurance companies for the same service by the same hospital, ...

Read more →

WHO recommends life-saving interleukin 6 receptor blockers for COVID-19 and urges producers to join efforts to rapidly increase access

7 July 2021 - The World Health Organization (WHO) has updated its patient care guidelines to include interleukin-6 receptor blockers, a ...

Read more →

Change to PBS Closing the Gap program sees Aboriginal patients inadvertently charged more for medication

7 July 2021 - On NAIDOC week, some Aboriginal and Torres Strait Islander patients have been forced to pay more for ...

Read more →