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Icentia Receives U.S. Food and Drug Administration (FDA) Clearance for CardioSTAT®

Legacy MEDSearch

CardioSTAT has now become the leading wearable cardiac monitoring solution in Canada. Expansion has followed in 2018 with the United Kingdom, where it is experiencing an exceptional adoption rate. Food and Drug Administration (FDA) Clearance for CardioSTAT® appeared first on Legacy MedSearch | Medical Device Recruiters.

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A perfect storm for biotech stocks

World of DTC Marketing

According to STAT News “after a double-digit decline in 2021, the sector has fallen another 20% in the new year, erasing billions in value and leading even the most seasoned investors to question whether biotech has further to fall. Meanwhile, the Food and Drug Administration has delayed several drug approvals, and Sen.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few?

Marketing 103
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Alimera Sciences buys US rights to EyePoint’s Yutiq

Pharmaceutical Technology

It received approval from the US Food and Drug Administration in October 2018. Alimera Sciences has acquired the US commercialisation rights for Yutiq (fluocinolone acetonide intravitreal implant) 0.18mg from EyePoint Pharmaceuticals.

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Progressing personalised cell therapies in oncology

European Pharmaceutical Review

Last month, CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) was the first BCMA-targeted CAR-T cell therapy to be approved for second-line treatment of multiple myeloma by the US Food and Drug Administration (FDA). Imran joined Oncology US Medical Affairs in 2018 as the Therapeutic Area Lead, Lymphoma and Myeloid Malignances.

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Early diagnosis in Alzheimer’s disease: A first step towards better care

Clarivate

It has been shown that Aβ deposition can begin more than 20 years before symptom onset (Gordon, 2018), and that accumulation of NFT starts during the preclinical stage (Counts, 2017), when cognitive function appears normal (Anon., Currently, of the eight drugs approved by the U.S. Food and Drug Administration, 2023 and 2024).

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Reflecting on five years of quality control for nitrosamine impurities

European Pharmaceutical Review

Based on scientific knowledge and process understanding, manufacturers of drugs and drug substances have a broad awareness of potential impurities – including nitrosamine impurities – that could form during manufacturing or degradation. 1 Nitrosamines are not new or unknown impurities.