News

La Jolla’s acquisition of Carterra’s LSA Platform is designed to advance their immunological and infectious disease research.

Synthego has launched new engineered cell libraries to validate targets for quicker drug discovery timelines.

Better clinical data are needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.

Ipsen and Marengo Therapeutics will collaborate to advance two precision immuno-oncology candidates.

CRYOPDP is expanding its footprint to Spain with its acquisition of Polar Expres.

Bio-Rad has expanded its range of recombinant monoclonal anti-idiotypic antibodies.

The new facility in Albany, Ore., will support biopharmaceutical development and lyophilization services.

FDA’s hybrid inspection model will remain a regular means for supplementing onsite inspections and will be further integrated into the agency’s oversight operations.

DuPont’s new manufacturing site will expand its biopharmaceutical tubing manufacturing capabilities.

The European Commission has granted marketing authorization to Upstaza (eladocagene exuparvovec) for treatment of aromatic L-amino acid decarboxylase (AADC) deficiency.

Shimadzu’s new ultra-high performance liquid chromatography system is designed to solve common problems in biopharma analysis.

Roche’s new test is the first available immunoassay that allows for simultaneous, independent determination of the hepatitis C virus antigen and antibody status.

WuXi STA is opening a new large-scale oligonucleotide and peptide manufacturing facility.

Scrutiny of accelerated approvals has generated a range of reform proposals to accelerate the conduct of confirmatory studies.

Discovery Life Sciences’ acquisition of AllCells is intended to bolster its cell and gene therapy products and services.

AstraZeneca's acquisition of TeneoTwo will give the company access to its clinical-stage T-cell engager, TNB-486, strengthening their hematological cancer pipeline.

WHO has determined that monkeypox constitutes a public health emergency of international concern.

The agency’s human medicines committee recommended drugs to treat breast cancer, lupus nephritis, type 2 diabetes and more.

A joint statement calling for international collaboration on the creation and use of real-world evidence has been published by the International Coalition of Medicines Regulatory Authorities.

Hospira has issued a voluntary nationwide recall for one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), due to the potential presence of visible particulate.

TFF Pharmaceuticals is expanding its R&D operations with a new facility in Austin, Texas.

The PerkinElmer Flow Cytometry Instrument Concierge Services will provide biopharmaceutical labs with expert, on-site flow cytometry specialists.

Cytiva has acquired a new chromatography resins manufacturing site in the United States as part of its $1.5 billion capacity expansion investment.

Health Canada has authorized Moderna’s COVID-19 vaccine for use in young children aged six months to five years.

US legislators are devising strategies ahead of the reauthorization deadline for the FDA User Fee legislation.

Royalty Pharma is paying $1.6 billion for the royalty rights to Trelegy Ellipta, a treatment for COPD and asthma.

FDA has granted an Emergency Use Authorization to Novavax’s COVID-19 vaccine.

The European Medicines Agency guidance highlights key principles and examples of good practices to prevent and manage shortages of human medicines.