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 →

BeiGene and EUSA Pharma announce China NMPA approval of Qarziba (dinutuximab beta) for patients with high risk neuroblastoma

17 August 2021 - BeiGene and EUSA Pharma today announced that the China National Medical Products Administration has granted Qarziba (dinutuximab ...

Read more →

Pharmaceutical companies should pay for raiding nature's medicine cabinet

11 August 2021 - In 2019, the pharmaceutical industry profited from US$1·2 trillion of global spending on medicines. Most of this ...

Read more →

Tempus submits PMA application to the FDA for its xT-Onco assay

17 August 2021 - Tempus today announced the submission of a premarket approval application for its proprietary broad-panel DNA sequencing ...

Read more →

Novartis secures new approval in China for Cosentyx (secukinumab) in paediatric psoriasis

17 August 2021 - China NMPA approval reinforces that Cosentyx (secukinumab) is safe and effective for children and adults with psoriasis. ...

Read more →

Will Government further expand reimbursement for rare leukaemia drugs?

17 August 2021 - As the Government has gradually increased reimbursement for combination drugs treating chronic lymphocytic leukaemia, patients’ hopes ...

Read more →

EMA validates Bristol Myers Squibb’s applications for Opdivo (nivolumab) and Yervoy (ipilimumab) and Opdivo and chemotherapy as first-line treatments for unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma

17 August 2021 - Applications based on positive results from the Phase 3 CheckMate-648 trial, in which both Opdivo-based combinations demonstrated ...

Read more →

ICER publishes final evidence report and policy recommendations on therapies for atopic dermatitis

17 August 2021 - Given uncertainty about safety data on oral JAK inhibitors for other indications, a narrow majority of the ...

Read more →

Agios announces FDA acceptance and priority review of new drug application for mitapivat for treatment of adults with pyruvate kinase deficiency

17 August 2021 - PDUFA date set for 17 February 2022. ...

Read more →

FDA grants accelerated approval of Jemperli (dostarlimab-gxly) for dMMR recurrent or advanced solid tumours

17 August 2021 - Second FDA approval of PD-1 antagonist antibody under clinical development for solid tumours in collaboration with GSK. ...

Read more →

Helius Medical Technologies announces FDA breakthrough device designation for the treatment of dynamic gait and balance deficits following a stroke

17 August 2021 - Helius Medical Technologies today announced that it has received breakthrough designation from the U.S. FDA for its ...

Read more →

Oncopeptides' Pepaxto receives a permanent J code, clarifying reimbursement processes in hospital outpatient and physician office settings of care

16 August 2021 - Oncopeptides today announced that the Centers for Medicare and Medicaid Services has established a specific billing Level ...

Read more →

Information Act shows racism in PHARMAC’s decision-making

17 August 2021 - Paati Māori Co-leader, Debbie Ngarewa-Packer, has received information that blatantly outlines the inequity within PHARMAC and ...

Read more →

Final terms of reference and public consultation to the post-market review of opiate dependence treatment program medicines

17 August 2021 - The public consultation process for the post-market review of opiate dependence treatment program medicines is now ...

Read more →

PHARMAC to fund new cardiovascular medicine with amended Special Authority criteria

17 August 2021 - Pharmac has approved funding for a new medicine with substantial health benefits for around 75,000 New ...

Read more →

Abbott's Amplatzer Amulet device approved by FDA to treat people with atrial fibrillation at risk of stroke

16 August 2021 - Amulet is the first and only minimally invasive treatment option to offer immediate closure of the left ...

Read more →