Pharma News

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...

Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced positive topline...

Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration has informed the Company that it does not plan to hold ...

Korea’s antitrust regulator has fined AstraZeneca and Korean generics company Alvogen a combined $1.82 million for colluding to avoid competition.

Gilead Sciences and MacroGenics entered into a licensing and collaboration pact worth up to $1.7 billion to develop a bispecific antibody to treat hematological cancers. This comes only two months ...