
The agency recommended 77 drugs for marketing authorization in 2023, including 39 new APIs.

The agency recommended 77 drugs for marketing authorization in 2023, including 39 new APIs.

The acquisition will give Novartis full rights to CALY-002, Calypso’s lead product candidate.

FDA’s Center for Drug Evaluation and Research released its report on new drugs approved in 2023.

Charles River’s off-the-shelf rep/cap plasmids are intended to simplify gene therapy supply chains.

The acquisition marks a pivotal expansion for the company into the US market.

The agency is reviewing data on secondary malignancies related to T-cells for approved CAR T-cell medicines.

Through the acquisition of Harpoon Therapeutics, Merck will gain an investigational delta-like ligand 3-targeting T-cell engager under development for cancer treatment.

According to the Pharmapack Europe 2024 survey results, contract packaging will see growth over the coming 12 months.

CellVoyant has raised £7.6 million in seed funding to speed up the development of novel cell therapies.

The European Medicines Agency safety committee says there is a potential risk of neurodevelopment disorders in children born to men treated with valproate.

Boehringer Ingelheim is investing €120 million (US$131 million) into its Koropi, Greece site to expand production for new therapeutics.

As innovation accelerates, pharmaceutical regulators continue their path of maintaining proportion, balance, and restraint.

Pluri has launched PluriCDMO, a new contract development and manufacturing organization business that will offer cell therapy manufacturing services.

Regulators from around the world will gather to help shape the mRNA and RNA therapeutics landscape at an exceptional April 2024 Washington, D.C. convocation.

Clarivate's Drugs to Watch report highlights 13 potential blockbuster drugs and gamechangers set to launch in 2024.

MHRA has granted a Clinical Trial Authorization to PharmaKure for its oral combined drug for the treatment of mild cognitive impairment.

Nanoform has completed the First Subject First Visit in a trial evaluating the relative bioavailability of its nanotechnology-enhanced enzalutamide.

Cherwell Laboratories’ cleanroom microbiology solutions will join AnalytiChem’s group of seven companies across Europe, North America, and Australia.

In a deal worth up to $1.4 billion, GSK aims to acquire Aiolos Bio and gain an expanded pipeline of biologic-based respiratory therapeutic candidates.

The potential for superpotent drug initiated the voluntary recall.

The expansion will boost solid-phase peptide synthesis total reactor volume to 32,000 L.

MediWound has been granted an additional $6.7 million by the DoD to advance NexoBrid as a non-surgical field care solution for the US military.

Under the collaboration, Boehringer Ingelheim and Ribo will develop RNA-based therapeutics to treat NASH/MASH.

Roche will acquire select parts of the LumiraDx group related to that company’s point-of-care technology, which integrates multiple tests on a single instrument.

AstraZeneca’s acquisition of Gracell includes a clinical-stage autologous cell therapy targeting hematologic malignancies and autoimmune diseases and a proprietary manufacturing platform.

The new Europe headquarters will be the hub for the company’s European operations, including production of product.

European bio/pharma companies have no choice but to invest and adapt to the evolving industry needs.

Novel molecular glues are transforming targeted protein degradation.

UK scientists are once again able to participate in the Horizon European research programme thanks to a deal struck in 2023.

With the acquisition, AstraZeneca will gain a potential RSV and hMPV combination vaccine.