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February 13, 2023
After years of FDA issuing guidance documents and launching programs to encourage sponsors to seek broader representation in clinical trials, policy makers have added a “stick” to the process.
Pseudoephedrine is an oral treatment that can be used alone or in combination with other medicines to treat nasal congestion resulting from a cold, flu, or allergy.
The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study.
The technology is designed to enable patients to self-inject biologic-based therapies at home instead of a hospital setting.
February 09, 2023
Biden outlined a host of priorities for improving health care and building the economy during State of the Union address.
February 08, 2023
Pharmapack Europe has announced the winners of the 2023 Pharmapack Awards spanning five categories across two dedicated awards.
Roche’s Phase III global program, centered around the biologic crovalimab as a treatment for paroxysmal nocturnal haemoglobinuria, showed the drug was non-inferior to current standards of care.
February 07, 2023
Clinicians, pediatric patients, regulators, and more are being considered to further strengthen focus on unmet medical needs.
The change would impact every package and hundreds of systems.
Thermo Fisher and Celltrio are introducing a new automation platform to address critical scale-up challenges in biotherapeutics.