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 →

Sandoz supplemental biologics license application accepted by US FDA for biosimilar Hyrimoz (adalimumab-adaz) high concentration formulation

21 July 2022 - Submission supported by comprehensive analytical data package and clinical Phase I pharmacokinetics bridging study. ...

Read more →

ATAGI update following weekly COVID-19 meeting (20 July 2022)

21 July 2022 - The ATAGI met on 20 July 2022 to consider the latest developments relating to COVID-19 immunisation. ...

Read more →

TGA approves Padcev

21 July 2022 - Enfortumab vedotin is an antibody-drug conjugate targeting nectin-4, an adhesion protein located on the surface of epithelial ...

Read more →

Simulating colorectal cancer trials using real world data

20 July 2022 - Using real world data –based trial simulation approach, we aim to simulate colorectal cancer trials and ...

Read more →

For Medicaid insured patients with cancer, health insurance does not always mean health access

15 July 2022 - Although there has been a significant increase in the number of U.S. residents insured through Medicaid since ...

Read more →

The big squeeze?

20 July 2022 - With NHS England highlighting savings of £1.2 billion on medicines in three years coming from both ...

Read more →

FDA announces an Oncologic Drugs Advisory Committee meeting to discuss benefit/risk profile of Oncopeptides' Pepaxto

20 July 2022 - Oncopeptides today announces that the US FDA, has announced a forthcoming public advisory meeting of the ...

Read more →

FDA approves Qsymia for the treatment of obesity in adolescents ages 12-17

20 July 2022 - Vivus today announced that the U.S. FDA approved Qsymia (phentermine and topiramate extended-release capsules) for use in ...

Read more →

Karyopharm granted regulatory designations for eltanexor for the treatment of myelodysplastic syndromes

20 July 2022 - FDA fast track designation and European Commission orphan medicinal product designation underscore the significant need for ...

Read more →

Easier access to locally applied HRT to treat post-menopausal vaginal symptoms in landmark MHRA reclassification

20 July 2022 - From September women in the UK will be able to access Gina 10 microgram vaginal tablets without ...

Read more →

Statement by President Joe Biden on FDA and CDC authorising Novavax’s COVID-⁠19 vaccine for adults

19 July 2022 - Today is another step forward in our nation’s fight against the virus. Following an independent scientific review ...

Read more →

Pfizer and BioNTech complete submission to European Medicines Agency for Omicron BA.1 adapted bivalent vaccine candidate

19 July 2022 - Pfizer and BioNTech today announced they have completed a submission to the EMA for an Omicron-adapted bivalent ...

Read more →

Wugen receives US FDA fast track and rare paediatric disease designations for WU-CART-007 for the treatment of R/R T-ALL/LBL

19 July 2022 - Wugen, today announced that the U.S. FDA has granted fast track designation and rare paediatric disease ...

Read more →

Ascentage Pharma and Innovent announce the China NMPA accepted and granted priority review designation to a new drug application for olverembatinib for the treatment of drug resistant CML

19 July 2022 -  Ascentage Pharma and Innovent Biologics today announce that the Center for Drug Evaluation of China's NMPA ...

Read more →

ICER publishes final evidence report and policy recommendations on beti-cel gene therapy for beta thalassaemia

19 July 2022 - Independent appraisal committee unanimously determined that evidence is adequate to demonstrate that beti-cel provides a net ...

Read more →