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Roche's (RHHBY) Inavolisib NDA Gets FDA Priority Review Tag
Zacks via Yahoo Finance· 5 hours agoThe FDA grants priority review to Roche's (RHHBY) NDA for the inavolisib combination regimen for...
FDA sets review date for Merck's KEYTRUDA in mesothelioma treatment By Investing.com
Investing.com· 2 hours agoMerck & Co., Inc., a global healthcare leader, has announced that the U.S. Food and Drug...
Inspira Technologies' (IINN) ART100 Gets FDA 510(k) Grant
Zacks via Yahoo Finance· 4 hours agoRevenues of $511 million improved 17.7% from last year’s comparable figure. You can see the complete...
Immunocore advances melanoma trial to phase 3 after FDA talks By Investing.com
Investing.com· 2 hours agoThis decision comes after recent consultations with the U.S. Food and Drug Administration (FDA) and...
Milestone Pharmaceuticals Announces FDA Acceptance of New Drug Application for CARDAMYST™
Digital Journal· 9 hours ago(Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that the United States Food and Drug Administration ...
Cortechs.ai launches OnQ Prostate advanced imaging solution in US
Medical Device Network via Yahoo Finance· 11 hours agoApproved by the US Food and Drug Administration (FDA), the OnQ Prostate post-processing software...
Verona prepares for anticipated US launch of ensifentrine for COPD in Q3 2024
Pharmaceutical Technology via Yahoo Finance· 7 hours agoVerona Pharma’s PDE3/4 inhibitor gained the FDA’s interest after two positive Phase III clinical...
FDA upgrades safety alert for Hologic's breast cancer marking implant after 71 reported injuries
FierceBiotech· 5 days agoThe FDA is upgrading its safety warnings related to complications from Hologic’s implantable marker...
FDA authorises CamDiab’s CamAPS FX artificial pancreas app
Medical Device Network via Yahoo Finance· 2 days ago“It has been extensively...have shown a significant increase in time in range and a reduction in...
REMSleep Holdings Shareholder Update
NewMediaWire via Yahoo Finance· 5 hours agoCLEARWATER, FL - (NewMediaWire) - May 29, 2024 - REMSleep Holdings, Inc. (OTCQB: RMSL) gives an update on FDA 510(K) status.We received the AINN Letter (...
