Regenerative medicine company Mesoblast Ltd. received an early Christmas present from the FDA for approval of its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil ...

First, the good news about pandemics – and in 2024, there was big “good news.” Science Magazine named lenacapavir (Gilead Sciences Inc.) as the Breakthrough of the Year. In two separate trials, ...

Vanda Pharmaceuticals Inc.’s VGT-1849A, a selective antisense oligonucleotide (ASO)-based JAK2 inhibitor, has been awarded ...

South Korea’s Ministry of Food and Drug Safety cleared Acryl Inc.’s Acryl-D01 as the country’s first AI-based digital ...

As recently as last month, Lexicon Pharmaceuticals Inc. was holding out hope regarding the NDA for Zynquista (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 ...

With Alhemo (concizumab-mtci) from Novo Nordisk A/S, a third hemophilia drug in the past eight months has been approved by the U.S. FDA. The once-daily injectable prophylaxis is to prevent or reduce ...

In the 1970s, scientists from several countries proposed to reconstruct, one by one, all the neurons in the brain as they appear under an electron microscope. They started with a small worm.

As if the uncertainties surrounding an incoming administration weren’t enough, a landmark U.S. Supreme Court decision and a potential new avenue of liability for drug and device manufacturers could ...

The U.S. FDA’s authority was challenged on a number of occasions over the past few decades, but the rate is likely to pick up as the U.S. Supreme Court ruled recently that the agency cannot take ...

SK Bioscience Co. Ltd. won €50 million (₩75.5 billion, US$52.03 million) up front from Sanofi SA to expand an earlier agreement to develop and commercialize novel pneumococcal conjugate vaccines (PCVs ...

Cstone Pharmaceuticals Co. Ltd. has filed a clinical trial application in Australia seeking to initiate a first-in-human study of CS-2009 for solid tumors. The company plans to initiate a ...

In a deal worth $100 million up front and up to $1.25 billion in milestone payments, Bioarctic AB licensed its pyroglutamate-amyloid-β (pyroglutamate-Aβ) antibody program to Bristol Myers Squibb Co.