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Amid FDA turmoil Sarepta’s gene therapy worries begin to ease
But the impact of George Tidmarsh’s CBER appointment after Vinay Prasad’s abrupt resignation remains to be seen.
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Regs & Legs
news
Broad label FDA approval for phenylketonuria drug
Alongside Phase III data demonstrating significant efficacy in the rare disease, the FDA’s decision could position the small molecule as a future standard of care.
news
EU and US agree preliminary tariffs deal
Marking the first step in the negotiation process, this deal establishes key parameters of the final political agreement on trade and tariffs between the EU and US.
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Pharma Horizons: leading-edge formulation
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
article
What will shape the Pharma landscape in Q3 2025?
Upcoming drug approvals and clinical progress will be pivotal during the third quarter of the year, says GlobalData.
news
World-first legislation backs decentralised manufacturing
The landmark regulation establishes a future where highly personalised treatments are part of routine care, says MHRA’s Chief Executive.
news
MHRA approves needle-free allergy drug alternative
The MHRA's approval provides eligible patients with a novel delivery method that is convenient and non-invasive.
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UK Government publishes Life Sciences Sector Plan
While a focus on accelerating access for innovative medicines has been welcomed, industry representatives caution that current system infrastructure could hinder the plans proposed by the UK Government.
news
NICE recommends innovative cystic fibrosis therapy
Recommendation of the once-daily triple therapy increases the number of eligible cystic fibrosis patients who can access treatments in the UK.
news
Updated licensing agreement marks “major milestone” in global HIV response
The expanded agreement between ViiV Healthcare and Medicines Patent Pool (MPP) provides a more patient-centric treatment approach for HIV patients worldwide.
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Advancing endotoxin testing with sustainable recombinant LAL solutions
The pharmaceutical industry faces mounting pressure to modernise its testing methods, driven by concerns over animal welfare, sustainability, and the need for more reliable results. Following a recent webinar, Fujifilm Wako discusses its Pyrostar™ Neo+ reagent and reveals how recombinant technology is transforming endotoxin testing while addressing evolving industry demands.
news
FDA approves first-of-a-kind oral therapy for rare disease
The US drug agency’s authorisation provides hereditary angioedema (HAE) patients with the first new on-demand treatment in over ten years.
webinar
Harnessing AI to transform quality and manufacturing in life sciences
2 July 2025 | By MasterControl
This webinar explores innovative, purpose-built AI solutions that elevate compliance and efficiency in quality and manufacturing operations.
news
Novel pre-filled autoinjector receives EU approval
The EU authorisation offers a new treatment option for acromegaly, providing effective disease control and enabling convenient self-administration.
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Alliance for impact – advancing CGT development in Europe
Cell therapy expert Lindsay Davies, PhD, FHEA, discusses the key considerations for moving the needle to broader adoption of CGTs in Europe.
