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 →

Sutro Biopharma announces STRO-002 FDA fast track designation for patients with advanced ovarian cancer

18 August 2021 - Sutro Biopharma today announced that the U.S. FDA has granted fast track designation for STRO-002, a folate ...

Read more →

Joint statement from HHS public health and medical experts on COVID-19 booster shots

18 August 2021 - Today, public health and medical experts from the U.S. Department of Health and Human Services released the ...

Read more →

Update on Actemra (tocilizumab) supply in the U.S.

16 August 2021 - The unprecedented surge in worldwide demand and supply constraints driven by Delta variant spikes in much ...

Read more →

AmoyDx Pan lung cancer PCR panel receives MHLW approval as companion diagnostic for Tepmetko (tepotinib)

17 August 2021 - Riken Genesis, Amoy Diagnostics and Precision Medicine Asia today announced that the Ministry of Health, Labour ...

Read more →

Abiraterone acetate for treating newly diagnosed high-risk hormone sensitive metastatic prostate cancer

18 August 2021 - NICE has published final guidance on the use of Zytiga in newly diagnosed patients following an ...

Read more →

COVID-19 vaccines additional doses: codes & payment

16 August 2021 - The FDA amended the emergency use authorisations for both the Pfizer BioNTech COVID-19 vaccine and the ...

Read more →

Moderna COVID-19 vaccine approved by MHRA in 12-17 year olds

17 August 2021 - The UK regulator has confirmed the vaccine is safe and effective in this age group. ...

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 →