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FDA grants conditional approval for TransMedics’ OCS ENHANCE Heart trial
The US Food and Drug Administration (FDA) has conditionally approved TransMedics Group’s investigational device exemption ...
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FDA Crackdown on Trial Design: What July’s CRLs to Replimune and Capricor Mean for Sponsors
Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.
Replimune Receives Complete Response Letter from FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma
Detailed price information for Replimune Group Inc (REPL-Q) from The Globe and Mail including charting and trades.
Denali Therapeutics Inc. (DNLI) Secures FDA Priority Review for First-Ever Brain-Penetrant Hunter Syndrome Therapy
We recently compiled a list of 11 Best Future Stocks to Buy Now. Denali Therapeutics Inc. stands sixth on our list among the ...
TransMedics Receives FDA IDE Approval to Initiate Next-Generation OCS Heart Trial
TransMedics Group, Inc. ("TransMedics") (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, today ...
Sutro Biopharma Announces Research Collaboration with the FDA to Advance Regulatory Standards for Antibody Drug Conjugates
Detailed price information for Sutro Biopharma Inc (STRO-Q) from The Globe and Mail including charting and trades.