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Roche's (RHHBY) Inavolisib NDA Gets FDA Priority Review Tag
Zacks via Yahoo Finance· 3 hours agoThe FDA grants priority review to Roche's (RHHBY) NDA for the inavolisib combination regimen for...
Inspira Technologies' (IINN) ART100 Gets FDA 510(k) Grant
Zacks via Yahoo Finance· 3 hours agoRevenues of $511 million improved 17.7% from last year’s comparable figure. You can see the complete...
Milestone Pharmaceuticals Announces FDA Acceptance of New Drug Application for CARDAMYST™
Digital Journal· 8 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 ...
FDA panel votes against Novo Nordisk's weekly insulin shot
Becker’s Hospital Review· 1 day agoFDA committee votes against Novo Nordisk's weekly insulin shot for Type 1 diabetes due to elevated hypoglycemia risks and lack of additional benefits.
Cortechs.ai launches OnQ Prostate advanced imaging solution in US
Medical Device Network via Yahoo Finance· 9 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· 6 hours agoVerona Pharma’s PDE3/4 inhibitor gained the FDA’s interest after two positive Phase III clinical...
REMSleep Holdings Shareholder Update
NewMediaWire via Yahoo Finance· 3 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 (...
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...
What's the Difference Between Ozempic and Wegovy?
Health via Yahoo News· 2 days agoOzempic and Wegovy are GLP-1 medications that aim to improve blood sugar and obesity. While these drugs are similar, they differ in effectiveness and...
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...