Latest in Regulatory

Pfizer and BioNTech’s COMIRNATY COVID-19 vaccine wins FDA approval for seniors and high-risk individuals

The COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies

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Ensuring drug safety using AI models for adverse drug reaction prediction

Adverse drug reactions (ADRs) are a significant cause of hospital admissions and treatment discontinuation worldwide
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Roca secures EMA recognition of radiation maculopathy as a distinct indication and Orphan Drug Designation

Roca Therapeutics (Roca) announces the granting of Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) for its lead clinical candidate, RCT002, to treat radiation maculopathy

NICE recommends enfortumab vedotin with KEYTRUDA for adults in England/Wales with untreated metastatic urothelial cancer

The results from the Phase III study EV-302/KN-A39 showed nearly a doubling of survival rates in patients compared with those who received platinum-based chemotherapy, which is the current standard of care in the UK

Filter manufacturer maintains official seal of approval for health and safety

Inspectors from health and safety standards body BSI have praised a process filter maker’s “thorough and well-organised approach” to workplace safety management

WuXi Biologics Ireland receives EMA approval to manufacture an innovative biologic

This approval adds to WuXi Biologics’ multiple facilities, which have received EMA and FDA approvals for commercial manufacturing of the same product since 2023

ElevateBio BaseCamp achieves ICMC certification for commercial CGT manufacturing capabilities

ICMC certification delivered by Dark Horse Consulting certifies ElevateBio’s compliant and scalable manufacturing capabilities for advanced therapies using US and EU commercial-level evaluation standards

MHRA's approval of Sanofi's Teplizumab signals a new era in type 1 diabetes management

Imagine delaying a life-altering chronic illness. Teplizumab offers precious time, potentially freeing eligible individuals and their families from the immediate and overwhelming demands of T1D

Shilpa Medicare's NorUDCA makes history as first approved NAFLD therapy worldwide

Shilpa Medicare emerges as a global pioneer by receiving approval for NorUDCA, offering new hope to more than a billion people affected by Non-Alcoholic Fatty Liver Disease (NAFLD)

Sustainability that performs: how GEA is building a better future for pharma

By embedding ESG principles into pharmaceutical manufacturing, GEA is delivering measurable sustainability performance without compromising compliance or productivity

Latest posts in Regulatory

Veranova’s Devens site passes FDA inspection with zero observations

This result demonstrates Veranova’s commitment to driving the highest standards of quality and compliance, and delivering consistent and reliable product supply for customers and patients

New whitepaper details regulatory requirements needed for transition to low-GWP medical propellants

Orbia has published a new whitepaper about the industry’s ongoing transition to pressurised  metered dose inhalers (pMDIs) to low global warming potential (Low-GWP) propellants

Amphastar Pharma’s iron sucrose injection receives US FDA approval to treat iron deficiency anaemia in patients with CKD

Amphastar Pharmaceuticals has received FDA approval for its generic iron sucrose injection and plans to launch it in Q3 2025, targeting a significant US market

Woodley BioReg secures GMP authorisation for two Umesh Modi Group businesses

Licences approved for international pharmaceutical distribution following expert regulatory and quality support plus training

NICE recommends MSD’s KEYTRUDA with carboplatin and paclitaxel for endometrial cancer

NICE recommends first-line treatment option for adult patients in England living with untreated primary advanced or recurrent endometrial cancer, representing an additional first-line treatment for patients

ASTM standard enhances RNA-LNP characterisation in drug development

New guide offers optimal methods to improve analysis and quality of RNA-based therapeutics

European Commission approves CAR-T therapy with lentiviral vectors from AGC Biologics

Following news on July 21 that the EC has granted marketing authorisation for AUCATZYL (obecabtagene autoleucel – obe-cel), AGC Biologics’ Milan site achieved its 10th product approval from the EMA or US FDA
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Start with the end in mind: the role of materials control in early CMC strategy for cell therapies

Cell and gene therapy products are complex in their design, nature and mode of action. Because of this, the road to market can be a challenging one; littered with variables and failures, what might have been a valuable treatment often fails to reach much-in-need patients

Piramal Pharma posts steady Q1FY26 results with growth in CDMO and consumer segments

Company maintains zero OAI status, expands US capacity, and sees strong e-commerce gains

UK point of care manufacturing legislation: why it matters

On 23 July, new UK legislation governing vaccine manufacturing at point of care locations (such as hospitals and pharmacies) came into force, transforming the personal healthcare landscape

Takeda receives FDA clearance for HyHub devices to simplify HYQVIA administration

Needle-free infusion tools aim to improve in-home treatment for primary immunodeficiency and CIDP

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Suncombe launches compact pH neutralisation systems for labs and small facilities

Expanded SUNpH range delivers compliance and performance in space-limited settings

One family’s journey from diagnosis to gene replacement therapy

How the Krueger family, supported by clinicians, researchers, and manufacturers, accelerated a novel treatment for ultra-rare NEDAMSS in just 14 months

Scalable chemistry and cross-sector expertise at CARBOGEN AMCIS Manchester

How the Manchester site delivers flexible solutions from early-phase synthesis to cosmetics GMP

Innovative silicone tubing for increased application pressure in (bio-)pharma

Raumedic launches SILMOTION-H transfer tubing to meet higher pressure requirements in pharma fluid handling

Inhalytix+ streamlines cascade impaction data analysis

Copley launches connected software to automate inhaler testing workflows

Atlas Copco unveils upgraded TCX chillers for precise pharmaceutical cooling

New R32 refrigerant and advanced technology reduce emissions and boost energy efficiency

Thermo Fisher launches new Heratherm Environmental Chamber for high-performance stability testing

The sustainable, precision-controlled chamber meets 21 CFR Part 11 and ICH guidelines

The foundations of pharmaceutical compliance for beginners

Whether you’re stepping into the pharmaceutical industry for the first time or pivoting into a compliance or quality assurance role after years of experience, mastering...

Precision under pressure

Why pharma manufacturing needs a harder look at weight control

Gerresheimer achieves leadership status with A- CDP score

Sustainability progress earns strong rating for climate disclosure and emissions strategy

Why rigorous clinical evaluations matter: strategies to boost safety and compliance

This white paper provides a blueprint for achieving excellence in clinical evaluations through strategic enhancements

Why integrated drug–device testing is critical in autoinjector development

A guide to robust testing strategies for accelerating timelines and reducing regulatory risk

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