The first round of the U.S.’ Medicare negotiations accounted for a lot of digital ink and headlines in 2024. Next year is sure to bring more of the same as Medicare is to announce up to 15 Part D ...
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The U.S. FDA’s newest draft guidance for dealing with medical product misinformation might seem to signal a cooperative attitude toward misinformation on the agency’s part, but regulatory attorney ...
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 ...
Engineered probiotics, mainly bacterial probiotics, are an emerging platform for in situ delivery of therapeutics, including anticancer therapies, to the gut. Writing in Cell Chemical Biology, ...
Epirium Bio Inc. has obtained IND clearance from the FDA for MF-300, a first-in-class orally administered, 15-hydroxyprostaglandin dehydrogenase (15-PGDH) enzyme inhibitor.
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, ...
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 ...
Investors will get more details during the International Lewy Body Dementia Conference in Amsterdam late next month, but Wall Street is already buzzing about ...