A new twice-yearly shot could be a "game changer" in the fight against AIDS, but experts' hopes have dimmed because of the ...

Earlier, in January 2025, the FDA released a companion piece of draft guidance titled “Considerations for the Use of ...

Donanemab was approved by the FDA in July 2024 to treat adults with early symptomatic Alzheimer's disease with confirmed ...

Eight years after it was established partly by AstraZeneca, Dizal Pharmaceuticals has gained its first FDA approval, winning an accelerated nod for Zegfrovy (sunvozertinib) to become the only ...

In a primary efficacy population of 85 patients, the confirmed overall response rate was 46%.

ZEGFROVY is the only approved targeted oral treatment for NSCLC with EGFR exon20ins Approval follows the U.S. FDA's Priority Review and is supported by the pivotal WU-KONG1 Part B study, in which ...

Regeneron Pharmaceuticals has won FDA accelerated approval of its Lynozyfic treatment for certain patients with the blood cancer multiple myeloma.

Zegfrovy (sunvozertinib) received accelerated FDA approval for NSCLC patients with EGFR exon 20 insertion mutations post-platinum-based chemotherapy progression. The Oncomine Dx Express Test was ...

Evidence-based recommendations on nemolizumab (Nemluvio) for treating moderate to severe atopic dermatitis in people 12 years and over. Last reviewed: 02 July 2025 Next review: This guidance will be ...

The FDA has given accelerated approval to the BiTE, linvoseltamab, for use in the fifth line of therapy for relapsed/refractory multiple myeloma.

Regeneron’s approval is based on compelling clinical trial data that showed Lynozyfic’s strong performance in this difficult-to-treat population. In the Phase 1/2 LINKER-MM1 trial, which studied the ...