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Medicines and Healthcare products Regulatory Agency

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Seasonal influenza vaccine research advances as CSL Seqirus reports Phase 3 data from a 7,699-participant study supporting its enhanced flu vaccine strategy, while mixed A/H3N2 results highlight the challenges of broad influenza strain protection. Representative image.
Pharma & Biotech

CSL Seqirus Phase 3 influenza vaccine study tests triple-enhancement strategy in older adults

CSL Seqirus’ 7,699-person Phase 3 study supports its enhanced flu-vaccine strategy, though one A/H3N2 comparison missed non-inferiority.

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Representative image: Huntington’s disease gene therapy research as uniQure submits AMT-130 for accelerated FDA approval following three-year clinical data.
Pharma & Biotech

uniQure takes one-time Huntington’s gene therapy to FDA after pivotal regulatory turnaround

uniQure files AMT-130 for accelerated FDA approval after three-year Huntington’s disease data showed a 75% slowing in progression.

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Dunbar Pharma targets UK compounding market with EU GMP dronabinol API
Pharma & Biotech

UK already had dronabinol APIs. What makes Dunbar Pharma’s plant-derived entry different?

Dunbar Pharma brings plant-derived dronabinol API to the UK through IPS Pharma, opening a new pharmaceutical cannabinoid supply route.

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A representative image illustrating Hemab Therapeutics’ sutacimig research as the once-weekly therapy moves toward a pivotal Phase 3 trial after sustained reductions in bleeding among patients with Glanzmann thrombasthenia.
Pharma & Biotech

FDA endorsement moves once-weekly sutacimig into decisive Glanzmann thrombasthenia study

Sutacimig gets an FDA-backed Phase 3 path after sustained bleed reductions in Glanzmann thrombasthenia. Read what the pivotal trial must prove.

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Representative image: A cardiologist reviews heart imaging as Cytokinetics’ $CYTK aficamten gains UK approval and NICE backing for approximately 6,600 adults with symptomatic obstructive hypertrophic cardiomyopathy.
Pharma & Biotech

Aficamten wins UK approval and NICE backing for 6,600 adults with obstructive HCM

Aficamten gains UK authorisation and NICE backing for symptomatic obstructive HCM after Phase 3 improvements in exercise capacity.

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Digital critical care monitoring in a modern hospital setting, reflecting FIZE Medical’s European and UK commercial expansion after CE marking and UKCA certification for the FIZE kUO automated urine output system. Representative image.
Medical Devices & Diagnostics

FIZE Medical receives CE marking and UKCA certification for FIZE kUO

FIZE Medical’s CE and UKCA milestones open Europe and Great Britain to FIZE kUO, shifting attention to ICU adoption and clinical evidence.

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Tenpoint Therapeutics is seeking MHRA authorisation for Yuvezzi, a once-daily dual-agent presbyopia eye drop for blurry close-up vision in adults. Representative image.
Pharma & Biotech

Tenpoint wants Yuvezzi to open a new UK presbyopia market, but another eye drop filed first

Tenpoint Therapeutics seeks UK authorisation for Yuvezzi, testing whether a dual-agent presbyopia eye drop can build a market beyond the United States.

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Representative image of a doctor discussing needle-free allergy treatment with a child and caregiver, reflecting coverage of EURneffy 1 mg’s UK approval for pediatric anaphylaxis care.
Pharma & Biotech

Why EURneffy’s UK pediatric approval could change emergency allergy treatment for children

Find out how EURneffy 1 mg’s UK approval could change needle-free anaphylaxis treatment for young children today.

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