USA – Dems urge free OTC birth control while GOP fights to ban mail-order...
US Democratic senators have signed a letter to the Biden administration to issue guidances that ensure Perrigo’s over-the-counter birth control pill Opill (norgestrel) is...
USA – FDA draft guidance aims to ensure accurate measurements of pediatric growth
Joint draft guidance from two centers at the US Food and Drug Administration (FDA) outlines ways sponsors can measure pediatric growth consistently in clinical...
Europe – First RSV vaccine to protect infants up to 6 months of age...
EMA has recommended granting a marketing authorisation in the European Union (EU) for Abrysvo, a vaccine to protect against disease caused by the respiratory syncytial virus (RSV)....
France – L’ANSM classe plusieurs vaccins sur la liste I des substances vénéneuses
L’ensemble des vaccins, à l’exception des vaccins grippaux, est désormais classé sur la liste I des substances vénéneuses, à la suite d’une décision de...
UK – NICE nod for AstraZeneca’s Lynparza
Therapy treats patients with specific types of ovarian, fallopian tube or primary peritoneal cancer
The National Institute for Health and Care Excellence (NICE) has recommended...
Europe – Report: How EU ensured safety of medicines during COVID-19
Preparedness for intensified monitoring, methodologies based on established pharmacovigilance tools as well as on innovative approaches and the flexibility and commitment of all the stakeholders...
Europe – EMA confirms recommendation for non-renewal of authorisation of Duchenne muscular dystrophy medicine...
Update as of 21 May 2024
The European Commission has asked the CHMP to review its January opinion on the renewal of the marketing authorisation for Translarna. The CHMP will now consider the...
USA – FDA issues guidance documents on labeling drug identity, constituents
The US Food and Drug Administration (FDA) has issued two draft guidance documents aimed at improving the consistency of labeling for both over-the-counter (OTC)...
USA – FDA finalizes umbrella trial guidance for cell and gene therapies
The US Food and Drug Administration (FDA) laid out its recommendations for sponsors to study multiple versions of a cellular or gene therapy in...
UK – Roche’s Polivy recommended by NICE for lymphoma therapy
In final draft guidance, NICE recommended the antibody drug conjugate be used in combination with rituximab, cyclophosphamide, doxorubicin and prednisolone (R-CHP) for untreated diffuse...
