This is the first time the Agency has authorized the Phase 3 clinical evaluation in the U.S of a microbiota-based live biotherapeutic based on a pooling technology
Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression
The Indian government will float a global tender in April 2023 to procure HPV vaccines.
This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
At commercial scale, Bluestem's patent pending technologies will reduce carbon emission by an estimated 75% or more and be cost-competitive with petroleum based chemicals
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients
The partnership is announced at Aero India 2023, Bangalore
Label expansion for CIBINQO provides new systemic oral option for adolescents (12 to <18 years) with moderate-to-severe atopic dermatitis
This clearance allows the company to initiate a clinical trial for patients with an ileal pouch-anal anastomosis
The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial
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