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Venclexta was previously granted provisional approval in this setting under the FDA’s accelerated approval program in November 2018. Today’s FDA approval converts Venclexta’s accelerated approval in this setting

The approval from an Indian regulator allows conducting an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in the country. According to RDIF, the multi-centre and

Preclinical evaluation of MRT5500, importantly, demonstrated a favorable immune response profile against SARS-CoV-2. These data support the selection of MRT5500 for clinical development. A Phase 1/2 clinical trial

The approval is based on results from the Phase 3 KEYNOTE-204 trial in which KEYTRUDA significantly reduced the risk of disease progression or death by 35% (HR=0.65 [95%

The deal also allows Disarm equity-holders to secure up to $1.225bn in additional future payments for potential development, regulatory and commercial milestones based on the successful development and

The human adenovirus (hAd5) vector vaccine candidate has been designed to target both the inner nucleocapsid (N) and outer spike (S) proteins, said ImmunityBio. The N-protein has been

Medulloblastomas are invasive, rapidly growing tumors that, unlike most brain tumors, spread through the cerebrospinal fluid and frequently metastasize to different locations along the surface of the brain

Confirmation of eligibility was given in response to the submission of a letter of intent enabling Moderna to evaluate the opportunity for submitting a Marketing Authorization Application (MAA)

Inmazeb, which was previously called REGN-EB3, is now the first treatment to have been approved by the FDA for Ebola. The antibody cocktail has been indicated for the