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May 18, 2023
UK’s NICE has recommended Kapruvia as a treatment for adult patients with moderate-to-severe chronic kidney disease (CKD)-associated pruritus.
UK's NICE has recommended RINVOQ (upadacitinib) as a treatment option for adult patients in England and Wales with moderately to severely active Crohn’s disease.
The two draft guidance documents provide recommendations for the approval of pediatric drugs, biologics, and vaccines under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act.
May 17, 2023
The agency’s safety committee is reviewing hydroxyprogesterone medicines and issuing a reminder on safety issues regarding fluoroquinolone antibiotics.
The agency has published guidance on good practices for securing the supply of medicines.
The report outlines highlights from the agency’s medicines evaluations and milestones for 2022.
May 16, 2023
In a brief, the Federal Trade Commission cited concerns about the acquisition resulting in an increased monopoly on Amgen’s newly acquired thyroid eye disease and chronic refractory gout treatments.
May 15, 2023
Aseptic techniques must be practiced throughout all stages of biologics production.
Machine learning provides real-time data for process control of high-shear wet granulation.
May 12, 2023
Congress have initiated a range of legislative proposals to further manage PBMs and the pharma market.