Bristol Myers (BMY) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval ...
Bioconjugation presents an new frontier for pharmaceutical development, providing an option for improved drug efficacy across ...
Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences," HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the ...
She said focus area of the partnership for her country includes drugs regulations, indigenous manufacturing of active ...
The contract will support R&D of high-quality APIs for substance use disorders and mental health conditions, starting with synthesis and scale-up of psilocybin, which is derived from mushrooms.
The decision by the EC follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use released in January 2025 and was based on results from ...
BSI’s goal is to make QS-21 accessible to a wider range of vaccines and populations, particularly in low-income countries.
From the regulatory authorisation perspective, all medicinal products ... they intend to use and to support the notification for the responsibilities of QP are defined in EU GMP Annex 16 (1.4 ...
“They do have an artificial, almost medicinal ... products aren’t certified. CBDfx also says its products are exclusively produced in facilities that meet current good manufacturing practices ...
Waylivra’s approval is based on a positive opinion from the European Medicines Agency’s Committee for Medicinal Products Human Use (CHMP) earlier this year. This ran contrary to a decision ...