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Roche's (RHHBY) Inavolisib NDA Gets FDA Priority Review Tag
Zacks via Yahoo Finance· 4 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· 10 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...
REMSleep Holdings Shareholder Update
Digital Journal· 4 hours agoFDA request for more information). On 5/29/2024 REMSleep submitted answers to AINN Letter from FDA requesting more information. REMSleep expects to receive ...
FDA advisers weigh benefits of weekly insulin for people with diabetes
WXII-TV Winston-Salem· 3 days agoFood and Drug Administration, but a committee of agency advisers is divided on whether the benefits...
FDA panel votes against Novo Nordisk's weekly insulin shot
Becker’s Hospital Review· 2 days agoFDA committee votes against Novo Nordisk's weekly insulin shot for Type 1 diabetes due to elevated hypoglycemia risks and lack of additional benefits.
