
Eisai’s lecanemab-irmb was converted from an accelerated approval to a traditional approval.

Eisai’s lecanemab-irmb was converted from an accelerated approval to a traditional approval.

The agency is reviewing the medicines after receiving reports of self-injury and suicidal thoughts in patients using the type 2 diabetes treatments.

Start-ups are plagued with common issues that dramatically decrease their odds of achieving investor funding.

EMA looks to focus on mRNA vaccines because their classification depends on the target and/or whether they are obtained chemically or biologically.

The acquisition will continue to strengthen the area of conjugate vaccines and bioconjugate drugs and will expand Biosynth’s capabilities from good manufacturing practice facilities located in Berlin, Germany.

Parenteral packaging and handling advancements receive awards.

FDA's approval of Leqembi paves the way for wider coverage of the drug by Medicare and establishes a process for further clinical testing and evaluation of treatments for this widespread, debilitating condition

The transaction is expected to be completed by the end of 2023 where CorEvitas will become a part of Thermo Fisher’s Laboratory Products and Biopharma Services segment.

Caribou will maintain full ownership and control of its pipeline of allogeneic CAR-T and CAR-NK cell therapies.

Camena Bioscience has completed $10 million in Series A financing on the back of growing demand for DNA synthesis.

Thermo Fisher Scientific’s new tumoroid culture medium kit is designed to help cancer researchers better model the disease.

Eurofins Genomics Blue Heron’s novel mRNA synthesis service is designed for customizable applications.

EMA, the European Commission, and HMAs are phasing out the flexible regulations put into place during the pandemic.

Full Marketing Authorization has been granted for Novavax’s COVID-19 vaccine by the European Commission.

Chime Biologics, Leads Biolabs, and BeiGene have formed a three-way collaboration to advance the development and global manufacturing of Leads Biolabs’ lead mAb candidate, LBL-007.

Meletios Therapeutics has been awarded with funding worth €1.2 million (US$1.3 million) from Bpifrance’s Deeptech development program.

Syngene has acquired a multi-modal biologics drug substance manufacturing facility in Bangalore, India, from Stelis Biopharma.