Pharma News, 2022

Novavax has received FDA Emergency Use Authorization (EUA) for its adjuvanted COVID-19 vaccine for use as a first booster dose at least six months after completion of primary vaccination with an au...

The FDA has granted Tvardi Therapeutics’s TTI-101 a Fast Track designation for treatment of patients with relapsed/refractory locally advanced, unresectable or metastatic hepatocellular carcinoma...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted Avrobio an “innovation passport” under a new accelerated approval pathway — the Innovative Licensing and Acce...

Salarius Pharmaceuticals has paused new patient enrollment in its phase 1/2 clinical trial of seclidemstat for treating people with various forms of sarcoma, after the death of one patient in the ...

After a successful phase 1 study in which PTC518 reduced huntingtin protein by 30% to 50%, the company is pausing the US enrollment of its phase 2 study until additional data is provided to the FDA...

Backed by Pfizer, Merck KGaA and J&J, Nucleome Therapeutics secured £37.5 million (about $42.16 million) in an oversubscribed Series A financing round to mine the dark genome for precision med...

Noema Pharma has received FDA’s Fast Track designation for basimglurant for treatment of patients with trigeminal neuralgia, a condition that includes pain from the trigeminal nerve in the front ...

Jazz Pharmaceuticals and Zymeworks Inc. entered into a $50 million licensing agreement over zanidatamab, Zymeworks’ bispecific antibody targeting HER2, the companies announced Wednesday. ...

The European Commission has approved Gilead subsidiary Kite’s Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-ce...

WASHINGTON, DC—Robert Califf, MD, commissioner of the US Food and Drug Administration (FDA), today announced 19 new grants worth more than $38 million over the next 4 years to support clinical tr...

In a phase 2 study, fosgonimeton showed positive effects on measures of cognition, function, and neurodegeneration when taken as a monotherapy, prompting an unblinded interim analysis. ...

The FDA has pushed back its decision date on Biogen’s New Drug Application for tofersen for the treatment of patients with superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS), a ra...