
The Supreme Court’s action leaves open the prospect of further rulings that could undermine FDA’s approval process.

The Supreme Court’s action leaves open the prospect of further rulings that could undermine FDA’s approval process.

BioChain has reached partnerships with NanoString and 10x Genomics to extend its spatial multiomics services.

JMI Laboratories and bioMérieux will work to improve microbiology diagnostics tools.

A report from Business Standard highlighted India’s recent growth in the pharma sector.

GSK has reached an agreement to acquire late-stage biopharmaceutical company BELLUS Health.

SAB Biotherapeutics has received both breakthrough and fast track designations from FDA for its lead antibody drug candidate for treating influenza.

Jaeger notes that the program is focused on addressing specific scientific questions that will produce immediate impacts on how CDER and FDA make drug approval decisions.

Merck will acquire Prometheus Biosciences, a clinical-stage biotechnology company specializing in immune-mediated diseases, at a total equity valuation of $10.8 billion.

Moderna and Merck reported that a combination therapy involving pembrolizumab and an mRNA demonstrated a 44% reduction in recurrence or death in cancer patients compared to non-combination treatments.

AbbVie’s RINVOQ has received European Commission approval for the treatment of moderately to severely active Crohn’s disease.

Gamida Cell’s therapy is meant to reduce the risk of infection following stem cell transplantation.

Integrated systems combine functions.

Avid Bioservices has launched new CGMP mammalian cell manufacturing suites at its Myford, Calif., facility.

FDA has granted fast track designation to Caribou Biosciences for its allogeneic CAR-T cell therapy for relapsed or refractory multiple myeloma.

Under this partnership, the two companies will develop bioprinted tissue therapeutics for diabetes and obesity.

The construction will expand Catalent’s clinical supply facility in Schorndorf, Germany.

Ginkgo Bioworks has acquired StrideBio's AAV capsid discovery and engineering platform and has formed a partnership with WARF for development of next-gen cell therapies.

The acquisition of Cell Systems will bolster AnaBios’ portfolio of human tissue and cells for use in drug discovery.

Forecyte Bio has opened a new GMP facility in Shanghai just two months after its sister site in the United States.

The new site will include state-of-the-art cleanroom facilities, laboratories, R&D, and office spaces.

The decision was issued in a joint statement by the FDA Commissioner and Chief Scientist, and effective on April 11.

The BalanCD CHO media portfolio is designed to ensure maximized growth, viability, and productivity of CHO cell lines.

A document signed by members of more than 400 companies and investment firms decries the decision made by a federal judge concerning mifepristone, a medication used in abortions.

Will court challenges to FDA’s oversight authority open the door for multiple lawsuits to block agency decisions on all sides?

The agency is dealing with high demand for staff because of a surge in the development of cell and gene therapies.

If approved, Johnson & Johnson would pay $8.9 billion to resolve all current and future claims in its ongoing talc litigation.

FDA aims to address mounting criticisms of its accelerated approval pathway.

Lonza and ABL Bio are collaborating on the development and manufacture of bispecific antibody product.

NextPharma has acquired a leading European chewable tablets manufacturing site from Takeda in Asker, Norway.

Sartorius’ acquisition of Polyplus is designed to strengthen its cell and gene therapy capabilities.