When pharmaceutical companies develop a novel drug for the market, several steps are required to assess and regulate its safety, effectiveness, manufacturability, and reliability. These processes, and ...
(Reuters) -Eisai and partner Biogen said on Tuesday that the Japanese drugmaker has begun submitting data on a rolling basis to the US health regulator for a marketing application of a subcutaneous ...
Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...
IRVINE, Calif., Dec. 06, 2023 (GLOBE NEWSWIRE) -- Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company, today announced it has begun the FDA single-site process for its VitaGraft ...
Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that it has successfully completed generation and analysis of all key data required to ...
Shares of Capricor Therapeutics CAPR gained 8.4% on Thursday following the completion of the submission of a biologics license application (BLA) to the FDA seeking full approval for deramiocel to ...
In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI)[1] models in drug development and in regulatory submissions titled, ...
PRINCETON, N.J., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced it has successfully supported 300 completed submissions to ...
Advances in biofabrication and 3D in vitro model systems are transforming biomedical research, drug development, and toxicity testing. However, despite ...
Dublin, Dec. 12, 2025 (GLOBE NEWSWIRE) -- The "The FDA (Food and Drug Administration) Drug Approval Process Training Course (Feb 23rd - Feb 24th, 2026)" training has been added to ...
Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...
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