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.

Merck, known as MSD outside the United States and Canada, and Orion Corporation are collaborating to develop and commercialize a treatment for metastatic castration-resistant prostate cancer.

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.

Guest contributor Frederic Kahn discusses the state of the Indian pharmaceutical manufacturing industry.

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.

Vertex’s $320 million acquisition of ViaCyte will give the company complementary capabilities for its Type 1 diabetes therapy program.

Application for OTC contraceptive highlights efforts to broaden access to medicines.

WHO’s Science Council released a report calling for a collective effort to accelerate global access to genomics.

Merck, known as MSD outside the United States and Canada, now offers the Merck Digital Sciences Studio, designed to enable innovative tech for drug discovery and development.

Pfizer and Touchlight have signed a patent license agreement for Pfizer to use Touchlight’s doggybone DNA (dbDNA) in the manufacture of mRNA vaccines, therapeutics, and gene therapies.

Wacker is investing more than €100 million (US$100.5 million) to expand its Halle, Germany, site with an mRNA competence center.

Coya Therapeutics has secured intellectual property rights to the research, development, and manufacturing of exosome-polymer hybrids.

Bio-Rad’s CFX Opus Deepwell Real-Time PCR Detection System is designed to support researchers in developing nucleic acid detection assays.

Bio-Rad’s EconoFit Chromatography Column Packs support resin screening experiments in the development of protein purification workflows.

Some states look to block access to approved drugs.