Regulatory

Stay up to date with the latest regulatory news and analysis from across the global pharmaceutical, biotech, and life sciences industry. From FDA and EMA decisions to evolving compliance requirements and policy developments, our coverage tracks the regulatory landscape shaping drug development and market access.

Clinician reviewing tissue images on a tablet beside a microscope, illustrating Zolgensma tumour risk under review

Zolgensma Tumour Risk: Does the Gene Therapy Cause Tumours?

Preservative-free cosmetics in white jars, a tube and a dropper bottle, with microbe and lab test images and a safety shield

Preservative-Free Is Not Risk-Free: The Microbiology Behind Safe Cosmetics

Pharmacist in a sterile compounding room preparing a single peptide vial, illustrating US peptide compounding under the HHS policy

Peptide Compounding Explained: What the HHS Six-Peptide Policy Allows

Cereal box with front-of-pack labelling under a magnifying glass, beside an avocado, salt shaker and sugar cubes

What FDA’s “Healthy” Rule and Front-of-Pack Labelling Mean for Food Makers

Technician inspecting a vial of individualised mRNA therapy in a clean room, illustrating melanoma vaccine approval timing

Melanoma Vaccine Approval: When Could Intismeran Reach Patients?

Brain MRI showing multiple sclerosis lesions on a radiology monitor as a clock marks time, illustrating the wait for a fenebrutinib approval decisio

Fenebrutinib Approval: When Could the FDA Decide on Roche’s MS Drug?

Regulatory decisions determine which drugs and therapies reach patients, how quickly they move through the approval process, and what conditions govern their commercial use. In 2025 alone, the FDA approved over 45 novel therapies. For life science professionals, understanding the regulatory landscape is not optional. It is essential to building effective regulatory strategy.

Life Science Daily News covers FDA drug approvals, EMA marketing authorisations, MHRA decisions, Health Canada reviews, and developments from agencies worldwide, alongside ICH guidelines and regulatory harmonisation efforts. Reporting spans the full spectrum of regulatory pathways and submissions: new drug applications (NDA), biologics license applications (BLA), marketing authorisation applications (MAA), investigational new drug (IND) applications, accelerated approval, breakthrough therapy designation, fast track designation, priority review, orphan drug designation, emergency use authorisation (EUA), and PDUFA dates.

Biosimilar approvals, medical device clearances, CE marking, companion diagnostics, and product labelling requirements also feature. Beyond approval decisions, coverage extends to pharmacovigilance and drug safety, drug recalls, post-marketing surveillance, risk-benefit assessment, GMP, GCP, quality assurance, real-world evidence requirements, drug pricing and reimbursement, HEOR, market access strategy, and intellectual property and patent law.

Regulators worldwide are adapting to emerging technologies. The growing role of artificial intelligence and real-world data in regulatory decision-making is a developing story with major implications. Sources include regulatory filings, guidance documents, agency announcements, and expert commentary.

Explore the latest regulatory articles on this page. Whether you work in regulatory affairs, policy, or commercial strategy, subscribe for updates on the decisions that shape market access and drug development timelines.