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March 06, 2023
The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.
March 03, 2023
The new guidance provides detailed recommendations to drug developers with a target of helping to ensure that drug developers provide adequate information to assess potency at each stage of a product’s life cycle.
March 02, 2023
Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.
That wave beginning to crash over PhRMA’s gunwales may well emanate from a startup mindset, rather than Big Pharma or government policy pundits.
March 01, 2023
CHMP recommended the approval of AbbVie’s RINVOQ (upadacitinib) as a treatment for adults with moderate-to-severe Crohn’s disease.
February 28, 2023
Moderna and Merck’s investigational personalized mRNA cancer vaccine has been granted Breakthrough Therapy Designation by FDA.
February 27, 2023
WHO is appealing for US $392 million to reach 12.9 million people with essential health assistance in 2023.
Orchard Therapeutics has announced an agreement which will enable reimbursed access to Libmeldy for all eligible MLD patients in Sweden.
February 24, 2023
Sanofi’s once-weekly replacement therapy is FDA-approved for prevention and treatment of bleeding episodes in people with hemophilia A.
February 23, 2023
GAO calls for more oversight of institutional review boards in clinical trials.