The FDA accepts and grants priority review to BAYRY's sNDA for Kerendia to treat patients with a common form of heart failure ...

Bayer AG BAYRY recently announced that the FDA had accepted its supplemental new drug application (sNDA) seeking approval for Kerendia (finerenone) to treat a new indication. The sNDA seeks ...

The data will be filed with regulatory authorities to seek an expansion of the label for Nubeqa, according to Bayer, which developed Nubeqa in collaboration with Finland's Orion. The drug is ...

Jiangsu Hengrui Pharmaceuticals and its partner Elevar Therapeutics will have to wait even longer before their PD-1 inhibitor ...

Bayer’s push to become a top 10 oncology player is being spearheaded by prostate cancer drug Nubeqa (darolutamide), which it thinks could become a €3 billion-plus product if its label can be ...

Doubled the royalty and milestone portfolio to over 120 royalty assets with significant milestone potential through five transactions in 2024 Completed two whole company acquisitions to unlock shareho ...

Bayer was ordered to pay more than $2 billion by a jury in a Georgia state court in the latest legal case surrounding alleged ...

Brazilian drugmaker Hypera plans to launch next year a generic version of semaglutide, the active ingredient of Novo ...

Buying Canadian can be more complicated than it sounds, especially when it comes to medications and medical supplies.

These labels are important ... information that could potentially lead to hazardous administration of the drug and an adverse reaction. This scenario was most notable on the label "Do not chew ...