news
EMA accepts marketing application for ALS treatment
The EMA has accepted the marketing authorisation application for tofersen, which could be the first treatment for a rare genetic cause of ALS.
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Regulation & Legislation
news
EMA accepts momelotinib marketing application
The marketing authorisation application for momelotinib, a new oral treatment for myelofibrosis has been accepted by the EMA.
news
FDA approves Rezlidhia™ for leukaemia
Rezlidhia™ has been approved for adults with mIDH1 relapsed/refractory acute myeloid leukaemia by the US Food and Drug Administration (FDA).
news
First faecal microbiota product approved for C. diff
The first faecal microbiota product to prevent recurrence of Clostridioides difficile infection in adults has been approved by the FDA.
news
First paediatric EC approval of HIV drug
The European Commission has granted the first paediatric marketing authorisation for Gilead's low-dose Biktarvy® HIV tablet.
news
EC approves Libtayo® for metastatic cervical cancer
The European Commission has approved Libtayo® for cervical cancer and disease progression while on or after platinum-based chemotherapy, due to positive Phase III trial results.
news
NICE recommends combo therapy for gastroesophageal cancer
Nivolumab together with chemotherapy has been recommended in NICE final draft guidance for treatment of gastroesophageal cancer.
article
Can holograms help in the frontline fight against pharmaceutical counterfeiting?
With Europol advising that counterfeit pharmaceuticals continue to pose ‘…a substantial threat to the EU and affect most, if not all, member states’, Dr Paul Dunn, chair of the International Hologram Manufacturers Association, looks at developments in authentication holography.
news
EMA launches quality control group to aid medicine innovation
A new regulatory group, part of the European Medicines Agency, will aid innovative approaches for the development and quality control of medicines, including new technologies for EU patients.
news
FDA approves first gene therapy for Haemophilia B
Hemgenix, the first gene therapy for adults with Haemophilia B has been approved by the US Food and Drug Administration (FDA).
podcasts
EPR Podcast Episode 17 – Antimicrobial Resistance – Boumediene Soufi, Sandoz
Antimicrobial resistance represents a potentially unprecedented global health challenge. Tune in to this episode with Sandoz to learn more about the causes of AMR, why it is such a concern, and some of the actions being taken by pharmaceutical manufacturers to tackle the issue.
news
Clinical trials authorised for 3D-printed ulcerative colitis drug
The FDA gives clinical trial clearance to 3D-printed colon-targeted oral drug for ulcerative colitis, to help improve safety of the dosage release.
news
FDA priority review for AbbVie lymphoma bispecific antibody
The FDA has accepted priority review of epcoritamab for adults with relapsed/refractory large B-cell lymphoma, which could be the first subcutaneous bispecific antibody for large B-cell lymphoma.
news
Therapeutic-first for cold agglutinin disease haemolytic anaemia
The European Commission has approved Enjaymo®, the first-and-only approved therapeutic for haemolytic anaemia in adults with cold agglutinin disease.
news
FDA approves first drug to delay type 1 diabetes
The US Food and Drug Administration (FDA) has approved Tzield, the first drug that can help delay the onset of stage 3 type 1 diabetes in patients over eight years old with stage 2 type 1 diabetes.
