2024 Food and Drug Administration Networking 
PM360
FEBRUARY 12, 2024
Given that less than 10% of rare diseases currently have an available treatment approved by the United States Food and Drug Administration (FDA) , advocating for the speedy development of novel drugs and therapies is a crucial step in improving the quality of life for those affected. What is a Rare Disease?
European Pharmaceutical Review
FEBRUARY 8, 2024
Regulatory plans for the cystic fibrosis medicine By mid-2024, Vertex declared that it plans to submit a New Drug Application (NDA) to the US Food and Drug Administration and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in patients with cystic fibrosis aged six years and older.
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European Pharmaceutical Review
JULY 21, 2023
A recent report from the US Food and Drug Administration (FDA) shows that while the number of new drug shortages has fallen significantly from a high of 250 in 2011 to 49 in 2022, there was an increase in new drug shortages year-on-year. Globalisation and supply chain complexity are a factor.
Legacy MEDSearch
MARCH 7, 2024
Food and Drug Administration (FDA) announced the clearance of Dexcom’s device, marking it as the first continuous glucose monitor available over the counter. Dexcom disclosed its plans to make Stelo available for purchase online without the need for a prescription, starting in summer 2024. On March 5, the U.S.
Legacy MEDSearch
MARCH 1, 2024
Boston Scientific’s AGENT Drug-Coated Balloon (DCB) has been granted approval by the U.S. Food and Drug Administration (FDA) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ” The final results from AGENT IDE are expected to be presented at CRT 2024.
European Pharmaceutical Review
JUNE 27, 2023
At MaaT Pharma our donor-derived products are made through pooling (ie, mixing multiple donors), thus achieving a higher overall richness and standardisation of the resulting drug product. Conversely, in the US, it has always been clear and regulated as a drug.
Legacy MEDSearch
SEPTEMBER 13, 2023
Food and Drug Administration (FDA) via the 510(k) pathway, with potential clearance expected during the first half of 2024. The Company’s vision is to transform external breathing assistance for over 20 million patients each year that require ventilation and oxygenation via external mechanical ventilation machinery.
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