The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.

Gilead and MacroGenics will work together on bispecific antibodies for the treatment of blood cancers.

Ebvallo (tabelecleucel) would be the first EMA-approved therapy for patients with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease.

Takeda’s dengue vaccine is designed to prevent disease caused by virus serotypes 1, 2, 3, and 4 in individuals four and older.

Merck has exercised a $250 million option with Moderna to jointly develop and commercialize cancer vaccine mRNA-4157/V940.

Alexion’s acquisition of LogicBio is designed to accelerate the company’s growth in genomic medicines.

FDA amended its authorization for the Moderna and Pfizer-BioNTech bivalent booster vaccines to permit their use in children as young as five years old.

Russell Kneipp, who has been Spectrum’s COO since 2018, will assume the roles effective immediately.

CRB’s Horizons: Life Sciences report covers challenges facing manufacturers and how to keep pace with rapid innovation.

CBER maps modernization plan to handle surge in research and applications.

Agilent Technologies opened a Dissolution Center of Excellence in Craven Arms, United Kingdom, on Oct. 12, 2022.

Cytiva’s acquisition of CEVEC Pharmaceuticals strengthens the company’s cell line development and biomanufacturing capabilities.

Amphista Therapeutics and Domainex will work together to develop treatments focusing on targeted protein degradation.

OGT has launched the SureSeq Myeloid Plus panel and OGT Universal NGS Complete Workflow.

Thermo Fisher’s new centrifuge technology is designed to enable efficient, sustainable cell culture harvesting.

Freudenberg Medical’s Heflix TPE tubing is a high purity TPE intended for bioprocessing applications.

The UK’s MHRA has approved Colonis’ melatonin oral solution for sleep onset insomnia in children and adolescents with ADHD.

H.I.G. Capital’s portfolio company Aspire Pharma has acquired Morningside Healthcare and Morningside Pharmaceuticals.

Klucel xtend HPC is the latest addition to the company’s Klucel product line and further expands their controlled-release portfolio.

FDA has granted Fast Track designation for CUE-101, a treatment of recurrent/metastatic head and neck squamous cell carcinoma.

Pfizer has completed its acquisition of Biohaven Pharmaceuticals for approximately $11.6 billion.

Pharmaceutical Technology Europe pays tribute to the role Her Majesty Queen Elizabeth II had in promoting innovation within life sciences.

One can only learn the secrets of "fight club" by attending its meetings.

The 1VQ papers advocate for the idea that certain post-approval changes should be streamlined and expedited.

Novo Nordisk will pay up to $700 million for the exclusive rights to develop and commercialize candidates from Ventus Therapeutics NLRP3 inhibitor portfolio.

FDA has approved Relyrio as a once-to-twice daily treatment for patients with ALS.

Citius and the University of Pittsburgh will investigate I/ONTAK in combination with pembrolizumab for treatment of recurrent or metastatic solid tumors.

Forge Biologics will offer three grades of plasmid manufacturing services at its Columbus, Ohio, location.