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.

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.

A CPHI North America panel discussion forewarns that CDMO supply chains are potentially the biggest single risk to product resilience.

What can we take away from Pfifzer's acquisition of Seagen?

A further setback to the publication of the pharmaceutical legislative changes in Europe may mean time is running out for appropriate review before 2024 parliamentary elections.

Direct-to-consumer drug advertising has developed as a cottage industry which has been used to increase prescriptions immensely.

FDA has approved Evkeeza for young children with homozygous familial hypercholesterolemia.

Takeda received approval in Japan for a subcutaneous injection formulation of Entyvio (vedolizumab) for treating ulcerative colitis.

CDMO Exothera and biotech company Remedium are joining forces to scale up the manufacturing process for Remedium’s lead gene therapy candidate for treating osteoarthritis.

Takeda plans to build a new facility in Osaka, Japan, for the manufacture of plasma-derived therapies.