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.

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?

Orange prescription bottles in rows with one opened, illustrating PBM reform and US drug pricing

Why US Federal Legislation Is the Best Chance to Rein In PBMs

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.

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Microscope on a lab bench beside cosmetic actives in labelled dropper bottles, cream jars and petri dishes of powder

The Evidence Problem in Cosmetic Actives: Why In-Vitro Data Is Not Enough

Bepirovirsen NHS access: two prefilled syringes on a white tray beside a blood test form in a hospital clinic room

Bepirovirsen NHS Access: Will UK Hepatitis B Patients Get Hibsago?

Pathology laboratory microscope and tissue slides used to test for dMMR in dostarlimab rectal cancer patients

Dostarlimab Rectal Cancer: Will the NHS Offer It Outside Wales?

AI medical devices on a hospital ward: a clinician uses a touchscreen linked to a cloud-hosted model

When the AI Inside a Medical Device Belongs to Someone Else

Attendees at a hybrid public meeting discuss the FDA rare disease framework for drug development, with rare disease therapy vials in the foreground

FDA Rare Disease Framework: What Will It Change for Developers?

Quiet UK urology outpatient corridor with a consultation room door ajar, illustrating Anktiva NHS access for bladder cancer patients

Anktiva NHS Access: Can UK Patients Get It for Bladder Cancer?

Desk calendar with an ink loop spanning two months, illustrating the FDA national priority voucher review timeline.

The National Priority Voucher: Inside the FDA’s Shortest Review Pathway

Dermatologist discussing treatment options with a psoriasis patient, illustrating icotrokinra NHS access in the UK

Icotrokinra NHS Access: Will the Oral Psoriasis Pill Reach Patients?

Ripe longan fruit on a wooden plate, illustrating traditional foods and mandatory GRAS notification

When Familiar Is Not Documented: Mandatory GRAS and Traditional Botanicals

Smartphone showing health data charts beside a glowing security shield, illustrating SaMD regulatory strategy

A Regulatory Playbook for SaMD and Digital Health

Pathologist examining an immunohistochemistry slide of colon tissue to identify dMMR colon cancer

Will the NHS Offer Atezolizumab for dMMR Colon Cancer?

Glowing teal wireframe columns rising from a grid, representing a digital twin of a manufacturing process

Digital Twins Need a New Validation Trigger: Drift, Not Deployment