Latest in Regulatory

FDA refuses review for Moderna's mRNA flu vaccine

Moderna has said that it has received an RTF letter about its next-generation flu shot, a move it has called 'inconsistent' with previous feedback. The company is seeking a meeting with the FDA to determine the next steps

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New computational approaches could pave the way for safer medicines with fewer side effects

Advances in computational modelling and artificial intelligence are offering new ways to understand why medicines cause side effects and how to avoid them in future drug...
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Leqembi subcutaneous formulation granted Priority Review status in China

The Chinese drug regulators' decision to grant Priority Review designation to Eisai’s biologics licence application potentially accelerates approval of the at-home autoinjector option

Hims & Hers backs down on oral GLP-1 copycat after FDA pressure

Facing threats of legal action from Wegovy manufacturer Novo Nordisk and an FDA probe, the health and wellness company has decided to abandon its plans to offer a GLP-1 copycat

ECHA adds two hazardous chemicals to list of substances of very high concern

Companies are responsible for managing the risks of these chemicals and giving customers and consumers information on their safe use

NHS, MHRA and Medicines UK launch Project Revive to tackle medicine shortages

NHS England, the MHRA and Medicines UK have launched Project Revive, a collaborative pilot designed to address critical medicines shortages by fast-tracking dormant MHRA-approved licences and creating dedicated NHS purchasing arrangements to improve long-term supply resilience

En Carta Diagnostics bags FDA Breakthrough Device Designation for EC Pocket Lyme test

The rapid, Point-of-Need molecular diagnostic platform will fill a critical gap in early-stage detection of Borrelia bacteria, the cause of Lyme disease

FDA accepts first quality control standard for mesenchymal stromal cells

The FDA has accepted the first dedicated quality control protocol for mesenchymal stromal cells, recognising the Tasly 3P Characterisation Assay and setting a new regulatory benchmark for MSC safety and clinical performance

3PBIOVIAN secures French CIR certification for Spain and Finland R&D sites

The CDMO has obtained French Crédit d’Impôt Recherche (CIR) certification for its Pamplona and Turku sites, enabling French partners to access tax incentives when collaborating on recombinant protein and advanced therapy projects

Drug-loaded pellets: unlocking flexible oral dosage design with modern pelletisation technologies

Produced using advanced extrusion–spheronisation technologies such as GEA’s NICA systems, drug-loaded pellets are gaining traction as a flexible and scalable oral solid dosage platform that enhances release control, patient outcomes and manufacturing efficiency

Latest posts in Regulatory

Shilpa Medicare targets US approval for extended-release Ondansetron injection for CINV

Shilpa Medicare plans to pursue US approval and licensing partners for OERIS after a Phase III study in India met all primary and secondary endpoints and showed a strong safety profile in chemotherapy-induced nausea and vomiting

MedPharm completes FDA inspection of manufacturing plant in Durham

The topical drug product manufacturing facility in North Carolina successfully completed its FDA inspection for the commercial manufacture of drug products with no Form 483 issued plus an NAI classification

Ascletis secures FDA IND clearance for Phase II Study of oral GLP-1 candidate in type 2 diabetes

Ascletis has received US FDA IND clearance to begin a 13-week Phase II trial of ASC30, its oral small-molecule GLP-1 receptor agonist, evaluating efficacy, safety and tolerability in people with type 2 diabetes

Novo Nordisk wins positive ruling for semaglutide compound patent from China’s Supreme People’s Court

The company has welcomed a decision by China’s Supreme People’s Court affirming the validity of its semaglutide compound patent, strengthening confidence for foreign drugmakers operating in the Chinese market

Grifols receives US FDA approval for new fibrinogen concentrate: FESILTY (fibrinogen, human-chmt)

The fibrinogen concentrate complements Grifols’ bleeding management portfolio, expanding therapeutic options for patients

Hansa Biopharma submits BLA to FDA for Imlifidase in desensitisation for kidney transplantation

Imlifidase is an enzyme that rapidly and efficiently cleaves all types of immunoglobulin G (IgG) antibodies both intra- and extra-vascularly to inhibit IgG-mediated immune response

New pharmaceutical legislation in Europe agreed

The agreement is the most significant overhaul of the regulatory framework in more than 20 years and represents a huge opportunity to reshape medicines regulation in the EU

Grifols gets nod from European Medicines Agency for entire value chain of Grifols Egypt

The institution's certification endorses the entire plasma value chain under the highest European standards and opens the door for Egypt to, once domestic needs are met, export to other markets including Europe

Regulating innovation: a new focus on digital mental health technologies (DMHTs)

IMed Consultancy’s Benjamin Austin provides a clear understanding of how digital mental health technologies are innovating care and describes the evolving regulatory frameworks that ensure their safety and effectiveness

FDA considers black box warning for COVID-19 vaccines amid internal disputes

The US FDA is reportedly weighing a black box warning for COVID-19 vaccines — a move that has alarmed public health leaders and vaccine manufacturers, who say no new safety signals support such action

BIOSECURE Act on track to curb Chinese biotech investment in the US

The amended Act was included in the annual defence bill after failing to pass muster in the last key defence spending bill, but has some notable omissions

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Extract Technology fully integrates into Dec Group and unveils new company name

Dec Group UK reflects unified vision and strengthened capabilities for global customers

testo Saveris 1 update automates environmental monitoring workflows for pharma compliance

Testo Saveris, global leader in measurement solutions, has announced the latest software update for its testo Saveris 1 Environmental Monitoring System, designed to...

New thermal inkjet printer expands AM Labels’ coding portfolio

M2 system delivers high resolution variable data printing at production-line speeds

Why aseptic processing is critical for microsphere drug manufacturing

As microsphere-based drug delivery systems move from niche innovation to commercial reality, manufacturers face growing pressure to guarantee sterility without...

ten23 health QC lab to support commercial product testing for US customer following FDA approvals

This pivotal regulatory milestone enables FDA-compliant release and stability testing for injectable drug products throughout the clinical and commercial phases, in...

Autopack launches modular semi-automatic bucket line

Flexible system helps manufacturers improve efficiency and reduce costs

A-Z Color advances automated quality control in pharmaceutical label production

EyeC inspection systems help deliver zero-error labels and GMP-compliant reliability

ASTM acquires Insight SQC from Sabine River Partners

ASTM International has announced its acquisition of the Insight SQC platform and its customers through an agreement signed in October 2025

Work safely with hazardous substances – new Asecos catalogue available now

Asecos cabinets help minimise risks when storing flammable substances

Piramal Pharma Solutions’ bioconjugates facility in Grangemouth, UK, receives updated MHRA GMP certificates

These certificates cover all activities conducted in the site’s Helix building, including its supporting warehouse and laboratory areas

Updated MHRA GMP certificates strengthen Piramal’s bioconjugates capabilities at Grangemouth

Certification renewal supports clinical and commercial ADC development and manufacturing

Redefining QP training for today’s professionals

How NSF is making specialist learning more flexible and accessible

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