Browsing Tag
Medicines and Healthcare products Regulatory Agency
15 posts
CSL Seqirus reports stronger immune response with enhanced flu vaccine in adults over 50
CSL Seqirus has published pivotal Phase III results from 7,699 adults showing superior immune responses versus an adjuvanted egg-based flu vaccine, while the study design leaves real-world comparative effectiveness as a separate question.
AMT-130 reaches FDA as uniQure targets first disease-modifying Huntington’s therapy
uniQure files AMT-130 for accelerated FDA approval after a 75% slowing in Huntington’s disease progression. See the key catalysts ahead.
Lupin adds Yuvezzi to €190m VISUfarma bet as European ophthalmology strategy takes shape
Lupin has secured exclusive Yuvezzi rights across major European markets through VISUfarma, extending its €190 million ophthalmology investment into a differentiated prescription therapy that still requires regional approvals.
Fate Therapeutics bets on outpatient CAR T as FT819 enters potentially registrational study
FT819 enters a potentially registrational lupus nephritis trial with outpatient dosing as Fate tests whether off-the-shelf CAR T can scale.
Cytokinetics secures UK approval and NHS access for aficamten in obstructive HCM
UK approval and NICE reimbursement give aficamten access to 6,600 patients as Cytokinetics expands its global HCM commercial launch.
MedPal AI raises £5m as MPAL buys eMAR software and backs oral Wegovy launch
MedPal AI is combining pharmacy dispensing, care-home medication software and a private weight-loss clinic, but a 25% share-count expansion raises the execution bar.
Could pediatric anaphylaxis become the next growth opportunity for ALK Abelló’s EURneffy franchise?
Find out how EURneffy’s UK pediatric approval could strengthen ALK Abelló’s allergy strategy and challenge auto-injectors.
MHRA weight-loss drug raid exposes black-market risk behind Britain’s slimming jab boom
Weight-loss jabs are booming, and criminals are following demand. The MHRA raid shows how illicit supply is becoming a patient safety threat.
Novo Nordisk gets UK nod for single-dose Wegovy 7.2mg pen in obesity care
MHRA has approved the single-dose Wegovy 7.2mg pen for adults with obesity in the United Kingdom. Read what it means for patients and Novo Nordisk.
Can weight loss drugs cause fatal pancreas illness? UK raises red flag on GLP-1 therapies
UK strengthens pancreatitis risk warning for GLP-1 weight loss and diabetes drugs like Wegovy and Mounjaro. Find out what it means for health systems and pharma.