The agency’s safety committee is assessing reported cases of period irregularities associated with Comirnaty and Spikevax mRNA vaccines.

The agency’s safety committee is reviewing the use of Janus kinase inhibitors to treat inflammatory disorders because of the potential for major cardiovascular problems.

The agency recommended 53 new active substances in 2021, up 35% from 2020.

Thermo Fisher Scientific's solution for cell and gene therapies involves a combination of cold chain logistics, serialization compliance, and distribution

While companies today outsource numerous processes, from early development through to manufacturing, there are still many opportunities to realize the full potential of outsourcing services.

Novavax’s COVID-19 vaccine has received conditional marketing authorization from MHRA and provisional approval from Medsafe.

Piramal Pharma Solutions plans to construct a multipurpose ADC manufacturing and aseptic fill/finish facility in Grangemouth, Scotland, and to upgrades its existing API manufacturing facility in Morpeth, England.

China-based CDMO Asymchem acquires US-based chemical technology company Snapdragon.

EMA has started its evaluation of an application for the use of a booster dose of Comirnaty in adolescents aged 12–15 years.

FDA has approved sutimlimab-jome as a treatment for hemolysis in individuals with CAD.

In an agreement with MaaT Pharma, Skyepharma will build MaaT a dedicated 1500-m² microbiome ecosystem therapies manufacturing site.

Sartorius Stedim Biotech has completed the acquisition of the chromatography equipment division of Novasep.

The European Patent Office has granted another patent to Salipro Biotech, covering the composition-of-matter, methods, and uses of the company’s novel antigen technology.

CGT Catapult has partnered with MICA Biosystems to advance MICA’s regenerative medicine technology to the UK’s MHRA.

With new COVID-19 infections declining, the agency is resuming domestic inspections of drug manufacturing facilities.

MacroGenics will use Synaffix’s technology to investigate next-generation ADCs.

The acquisition will include Rewrite’s DNA writing platform, expanding Intellia’s genome editing tools.

The agency approved Roche’s Vabysmo to treat neovascular or “wet” age-related macular degeneration and diabetic macular edema.

Bio-Rad’s four new antibodies will develop highly selective and sensitive assays for bioanalysis and drug monitoring of pertuzumab and its biosimilars.

Gandeeva raisded $40 million to advance its AI-driven cryo-EM platform, with which it will develop new therapeutics based on the precise imaging of protein–drug interactions.

A range of political issues have impacted FDA initiatives vital to the agency’s effectiveness and stature, both at home and on the important global stage.

Domainex is collaborating with Parkinson’s UK for the development of small-molecule therapies targeting the neuroinflammation that is associated with Parkinson’s disease.

ABPI has responded to the publication of a white paper on ‘Levelling Up’ by the government of the United Kingdom.

Zetta Genomics has raised £2.5 million ($3.4 million) in new seed funding.

Janssen has submitted a MAA to the EMA for teclistamab as a treatment of relapsed or refractory multiple myeloma (RRMM).

pharmasol has completed the strategic merger with PharmaLex.

Pharming Group has announced positive results from the Phase II/III study of leniolisib for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS).

The UK’s NICE issued a Final Appraisal Document recommending marketing authorization for AstraZeneca’s chronic kidney disease treatment, Forxiga (dapagliflozin).