Tonmya now available for fibromyalgia; safety warnings for DMD treatment; mitapivat shows mixed results in sickle cell disease trial; Redemplo approved for familial chylomicronemia syndrome; Hyrnuo ...

The nod brings Bayer face-to-face in the market with Boehringer Ingelheim and AstraZeneca, each of which has its own HER2 ...

Berlin: Bayer has received accelerated approval from the U.S. Food and Drug Administration (FDA) for HYRNUO ...

Bayer’s Hyrnuo gets US FDA accelerated approval to treat patients with previously treated advanced HER2-mutant NSCLC: Berlin Friday, November 21, 2025, 11:00 Hrs [IST] Following ...

A new oral HER2-directed breast cancer therapy from Bayer AG, and its companion diagnostic from Thermo Fisher Scientific Inc.

The FDA also approved Thermo Fisher's Oncomine Dx Target Test as a companion diagnostic to identify patients eligible for Hyrnuo.

In patients naïve to HER2-targeted therapy, the objective response rate was 71% with a median duration of response of 9.2 months.

Regeneron announced the FDA’s approval of two indications of Eylea HD, including an 8mg injection for patients with macular ...

FDA grants accelerated approval to Bayer's Hyrnuo and full approval to Amgen's Imdelltra, expanding treatment options for ...

The accelerated FDA approval of Bayer's Hyrnuo covers treatment of advanced cases of non-small cell lung cancer with HER2 ...

A new report commissioned by KlariVis, a leading performance intelligence platform built for financial institutions, and conducted by Cornerstone Advisors, a leading provider of business and ...

U.S. FDA Approves HYRNUO® (sevabertinib) for Previously Treated Patients with HER2-Mutated Locally Advanced or Metastatic Non-Squamous NSCLC ...