EMA
5 stories in The Vital Record · Agency
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· Clinical Trials
Aficamten Beats Metoprolol on Exercise Capacity in Phase 3 Head-to-Head Trial for Obstructive HCM -
· FDA & Regulatory
FDA accepts a proposed Entyvio biosimilar for review; interchangeability not yet granted -
· Biotech Business
Servier to buy Edgewise's investigational dystrophy drug sevasemten for up to $2.65B as Edgewise turns to cardiology -
· FDA & Regulatory
EU regulators back AstraZeneca's camizestrant for ESR1-mutated breast cancer, guided by a ctDNA early-switch strategy -
· FDA & Regulatory
EMA committee recommends approving Boehringer's nerandomilast for two pulmonary fibrosis indications