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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, ...
South Korea’s Ministry of Food and Drug Safety cleared Acryl Inc.’s Acryl-D01 as the country’s first AI-based digital ...
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.
Vanda Pharmaceuticals Inc.’s VGT-1849A, a selective antisense oligonucleotide (ASO)-based JAK2 inhibitor, has been awarded ...
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 ...
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 ...
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 ...
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 ...
China's National Medical Products Administration (NMPA) approved Innovent Biologics Inc.’s NDA for Dovbleron (taletrectinib), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for treating ...
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 ...