Tristan Manalac

After the unexpected success of their PHOENYCS GO study for dapirolizumab pegol in lupus earlier this fall, Biogen and UCB are planning a second late-stage trial by the end of the year to support a drug application.

Readouts from Novo Nordisk and Viking Therapeutics at AASLD 2024 strengthen the argument for GLP-1 therapies as an emerging backbone of MASH treatment, with the potential to combine it with other drug classes to achieve deeper responses, according to BMO Capital Markets analyst Evan Seigerman.

After previously failing studies in Parkinson's and Alzheimer's, dalzanemdor's latest stumble in Huntington's disease has pushed Sage Therapeutics to pull the plug on the NMDA receptor modulator.

Makary is a pancreatic surgeon at Johns Hopkins who became known for battling medical mistakes and in recent years has been an outspoken critic of COVID-19 policies.

The agreement will give Kuro enough capital to support the development and launch of its menin inhibitor ziftomenib.

Lilly will provide the funding and expertise to advance Laekna's LAE102, a first-in-class monoclonal antibody targeting the activin type IIA receptor to induce weight loss and boost muscle mass.

Pending the FDA's decision, compounding pharmacies will remain free to make and market versions of the blockbuster weight-loss therapy.

The pharma is seeking full approval for its anticoagulation reversal drug Andexxa, which the FDA granted accelerated approval in 2018 for patients who had been treated with apixaban or rivaroxaban.

Despite the death, the FDA has allowed Neurogene to forge ahead with the Phase I/II Rett syndrome trial, but using only the lower 1E15 vg dose of its investigational gene therapy NGN-401.

FDA researchers have found new evidence of a molecular link between Merck 's former blockbuster asthma drug montelukast—which is now marketed by