European Pharmaceutical Review
NOVEMBER 13, 2023
The pharmaceutical company also highlighted that the decision was additionally supported by data from a subpopulation of adult patients with moderate to severe anaemia from the SIMPLIFY-1 Phase III trial. GSK shared that a decision on marketing authorisation for momelotinib in the EU is expected by early 2024.
Express Pharma
JUNE 12, 2024
The investigational combination vaccine displayed an acceptable safety and tolerability profile, with the most commonly reported adverse reactions being injection site pain, fatigue, myalgia, and headache.
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European Pharmaceutical Review
SEPTEMBER 2, 2022
This can be achieved by reducing the burden of adverse reactions or by optimising benefits through patient selection (eg, contraindications, recommendations of use, warnings, concomitant medicine[s], or certain test parameters) and treatment management (eg, specific dosing regimen, relevant testing, patient follow-up).
PharmaState Academy
MAY 29, 2024
2 / 15 How should a pharmaceutical company respond if its drug is found to have severe unreported side effects after market release? 3 / 15 How should pharmaceutical companies structure their post-marketing surveillance reports to align with UCPMP 2024 requirements?
pharmaphorum
MAY 12, 2022
The software can be used to conduct an initial analysis of adverse reactions to medications that have already been approved to identify potential side effects and undesirable events, and provides a decision-making tool for those working in pharmacovigilance, helping them process each case more quickly.
Digital Pharmacist
OCTOBER 24, 2022
When it comes to innovation in the development of new drugs and therapeutic biological products in the pharmaceutical industry, the United States Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) is a key supporter of the pharmaceutical industry. . Date of Approval: 9/21/2022.
Pharmaceutical Technology
JUNE 15, 2023
But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. During these phases, data is obtained from participants and monitored for adverse reactions or changes to health indicators, such as blood pressure or heart rate.
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