Pharmaceuticals, Biotechnology and Life Sciences
Regeneron Pharmaceuticals and Sanofi have received U.S. Food and Drug Administration (FDA) acceptance for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) to treat children aged 1 to 11 years with eosinophilic esophagitis (EoE).
ABRYSVO recommended by CDC Advisory Committee for pregnant persons 32 through 36 weeks gestation to help protect infants from respiratory…
AiCuris Anti-infective Cures AG has received milestone payments in the amount of EUR €30 million from its licensing partner MSD (Merck) after the U.S. FDA’s approval for first-in-class antiviral agent PREVYMIS® in a new indication – the prophylaxis of CMV disease after kidney transplant in Donor CMV-seropositive/Recipient CMV-seronegative patients.
The data showed that tiragolumab plus Tecentriq was well-tolerated and no new safety signals were identified when adding tiragolumab to Tecentriq.
Redx has received Orphan Drug Designation from the US Food and Drug Administration (FDA) for the potential treatment of Idiopathic Pulmonary Fibrosis (IPF) for Zelasudil, which is currently in a Phase 2a clinical study for IPF, with topline data expected in Q1 2024.
Launching in the fourth largest aesthetic toxin injectables market in Europe1 is part of the company’s geographic expansion strategy GP…
The Company to host an earnings conference call via webcast VICTORIA, British Columbia–(BUSINESS WIRE)–$IPA #AI–IPA (IMMUNOPRECISE ANTIBODIES LTD.) (the “Company”…
Moderna said Monday that both of its bivalent Omicron-targeting booster candidates (mRNA-1273.214 and mRNA-1273.222) trigger a superior antibody response compared…
In recent years, there has been an industry-wide recognition of the need for speed and agility. Accelerating the trial processes for COVID-19 vaccine candidates required proactive and cooperative efforts from participants at all points in the supply chain. A sense of urgency and an expectation that trials should be completed more quickly and effectively emerged as a result of the realization that a drug can be approved and released to the market in a relatively short period of time. In light of this, improving the speed, accuracy, and agility of clinical trials labeling — and more specifically, the translation of label content — is one of the crucial areas that would help organizations to achieve this.
The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a 10-µg booster dose of Pfizer BioNTech Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 5 through 11 years of age.