Latest in Pharmaceutical

MHRA approves every-four-week dosing regimen for Chiesi's Elfabrio in stable adult Fabry disease patients

The firm has received MHRA approval for an additional 2 mg/kg every-four-week dosing regimen for pegunigalsidase alfa, halving the number of annual infusions required for eligible adult Fabry disease patients from 26 to 13

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FDA issues first cGMP warning letter citing AI misuse in pharmaceutical manufacturing

A Michigan-based lab has become the subject of the FDA's first dedicated enforcement action on artificial intelligence misuse in drug manufacturing — a landmark event with...
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Rice-ing to the occasion: how plant-based excipients are gaining ground in pharmaceutical manufacturing

As clean-label expectations migrate from health foods into pharmaceutical supply chains, natural ingredient supplier RIBUS says that rice-based excipients are becoming a credible alternative to synthetic standards

Oncopeptides to seek EMA label expansion for Pepaxti to include third-line multiple myeloma treatment

The company has said it will submit a Type II variation to the EMA to expand Pepaxti's indication to include patients with multiple myeloma who have received at least two prior lines of therapy — a move that would double the addressable patient population and treatment cycle potential in Europe

SGS launches GMP-compliant NMR testing for Chinese pharma industry

The inspection and certification specialist will now offer nuclear magnetic resonance (NMR) testing for analysis of both drug substances and drug products across China

Romaco to debut Tecpharm 400 tablet coater with automatic baffle adjustment at Interpack

The Tecpharm 400 tablet coater is the first to automatically adjust baffle geometry as tablet bed volume increases, with an optional energy recovery system cutting consumption by up to 50%, alongside the VENTILUS Lab fluid bed processor, capable of reducing batch processing times by 25%

SCIEX expands integrated software ecosystem with six mass spectrometry workflow collaborations

The firm has announced six software collaborations designed to unify instrument control, data processing and compliance within a single analytical environment, with more partnerships set to be revealed at ASMS 2026

WHO prequalifies Novartis' antimalarial Coartem Baby for treatment of newborns and young infants

The decision allows global procurement of artemether-lumefantrine (also known as Riamet Baby in some countries) for the first time, with Novartis adding that it will make the treatment available on a largely not-for-profit basis in malaria-endemic regions

BD and Suttons Creek collaborate to streamline combination product development for pharma and biotech

The new strategic collaboration will help pharmaceutical and biotech companies reduce development risk and regulatory complexity across drug-device combination products, including biologics and GLP-1 therapies

From lab to launch: transforming pharmaceutical formulation development with GEA’s CFC Lab Coater

A new generation of continuous film coating technology is giving R&D teams the speed, precision and scalability they need to take products from the laboratory to commercial production without the traditional bottlenecks

Latest posts in Pharmaceutical

FDA grants Orphan Drug Designation to pegrizeprument for prevention of heart transplant rejection

The FDA has granted Orphan Drug Designation to pegrizeprument (VEL-101), a novel monoclonal antibody fragment licensed to Veloxis Pharmaceuticals, for the prevention of heart allograft rejection, following a similar designation granted for liver transplant rejection in January 2026

Cipla receives FDA approval for first AB-rated generic of Ventolin HFA in $1.5bn US albuterol market

Indian pharmaceutical company Cipla has secured final FDA approval for its Albuterol Sulfate Inhalation Aerosol, becoming the first AB-rated generic therapeutic equivalent of GlaxoSmithKline's Ventolin HFA

Japanese pharma companies shifting to earlier CDMO outsourcing as peptide complexity increases

Neuland Laboratories has reported a notable shift in Japanese pharmaceutical outsourcing patterns during the past 12-24 months, with companies engaging CDMOs earlier in the development cycle

UK REACH reform falls short as industry warns of £500m+ compliance bill

The UK chemicals industry has condemned the Government's long-awaited response to the UK REACH Alternative Transitional Registration model consultation, arguing it does little to support growth or innovation

Freudenberg Medical launches CleanAssure ISO Class 5 cleanroom service for sterile single-use biopharma assemblies

CleanAssure is an ISO Class 5 controlled cleanroom service delivering washed, dried and gamma-sterilised single-use assemblies to biopharmaceutical customers, addressing industry challenges around cleaning validation and contamination risk

Mabwell signs Malaysia licensing deal for denosumab biosimilars MAILISHU and MAIWEIJIAN

Mabwell has entered a licensing and commercialisation agreement to bring its denosumab biosimilars to Malaysia, supporting regional access through local registration and supply of its Prolia and Xgeva reference products

"Miracle" Alzheimer's drugs show no meaningful benefit, says major review

Amyloid-clearing drugs hailed as a breakthrough for Alzheimer's treatment make "no meaningful difference to patients" and increase the risk of brain swelling and bleeding, according to a sweeping new Cochrane meta-analysis

Aragen launches ChemiSHE, India's first women-led chemistry synthesis laboratory

The firm has inaugurated ChemiSHE, a pioneering all-women chemistry synthesis laboratory at its Hyderabad campus, as part of a broader diversity initiative targeting the addition of up to 1000 women employees across scientific and leadership roles during the next three years

Cleanroom Technology Awards 2026: The winners

The winners of the Cleanroom Technology Awards 2026 have now been revealed. The 2026 edition brought together some of the most forward-thinking organisations in the industry, recognising innovation, technical excellence, and impactful advancements across cleanroom design, operation, and technology

Haisco licenses novel pain compounds to AbbVie in deal worth up to $745 million

The pair have entered into an exclusive licensing agreement which grants AbbVie global rights outside mainland China to develop and commercialise its portfolio of novel pain compounds, with Haisco receiving a $30m upfront payment with potential milestone payments of up to $715m

Touchlight partners with SVF Vaccines to advance dual hepatitis B/D vaccine into clinical development

The pair will progress an innovative dual-targeting hepatitis B and D vaccine into clinical trials, leveraging Touchlight's enzymatic doggybone DNA platform, which has demonstrated significant dose-sparing potential compared to traditional plasmid DNA

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How the QA and QP Talent Market Is Changing in Pharma: Insights from Compliance Unlocked Podcast

Recruiting and retaining experienced quality and regulatory professionals has become significantly more complex for pharmaceutical and biotech companies

White paper: Leadership as the missing control in the Pharmaceutical Quality System (PQS)

Why senior management determines the effectiveness of the pharmaceutical quality system

Ardena strengthens executive team to drive its next phase of growth

Ghent, Belgium, 4 May 2026 – Ardena, a specialist pharmaceutical CDMO and bioanalytical CRO enabling precision medicines and other complex therapies, announces the...

Backed by investments exceeding $1 billion, PCI Pharma Services announces major expansion of US sterile fill-finish and drug-device delivery combination capabilities

As pharma manufacturers prioritise US supply chain resilience, highlights include high-speed isolator filling lines for prefilled syringes, cartridges and vials, and...

New Romaco Tecpharm 400 tablet coater at interpack

Ideal for pharmaceutical coatings with a very large weight gain

Batch recovery or batch rejection? Making better decisions when weight variability appears

Recent regulatory and quality-system developments are a reminder that decisions in pharmaceutical operations must be evidence-based, proportionate, and capable of standing...

From complexity to confidence: Smurfit Westrock finds a better way to ensure accuracy with EyeC

Demands for printing perfection and regulatory compliance, Smurfit Westrock faced growing complications in producing multilingual pharmaceutical inserts

Tekpak Automation to showcase pharma pick-and-place robotic cell at interpack 2026

Tekpak Automation will demonstrate the benefits of robotics for pharmaceutical applications at interpack 2026, with a LIVE working demonstration of a 3-axis pick-and-place...

Nulogy launches Supplier Compliance Management to build stronger, more resilient supplier networks

Nulogy, a leading provider of manufacturing operations software, announced the launch of Nulogy Supplier Compliance Management, a solution designed to centralise and...

The challenges of developing combination products

Regulatory complexity and the case for a holistic development strategy

The future of aseptic manufacturing: Compact and advanced solutions

As the pharmaceutical industry advances into more complex modalities, from biologics to cell and gene therapies, the need for flexible, aseptically robust fill-finish...

Compliance podcast: How EU law, AI and decentralised manufacturing are redefining the QP role

On the NSF Life Sciences Compliance Podcast, Dr Peter Gough speaks on where pharmaceutical quality is headed next

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