Tag: FDA

U.S Food and Drug Administration (FDA)

FDA Authorizes Robotic Device for Automated Blood Collection

FDA authorizes Vitestro’s Aletta, a robotic blood-drawing device designed to automate blood…

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Emergency Authorization Expands Treatment Options for New World Screwworm in Dogs

FDA grants emergency authorization for Simparica Trio to treat New World screwworm…

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FDA Grants Breakthrough Therapy Designation to Olomorasib for Advanced Pancreatic Cancer

The U.S. FDA has granted Breakthrough Therapy designation to Lilly's investigational KRAS…

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Major Acquisition to Advance Therapies for Treatment-Resistant Depression

Lilly will acquire AtaiBeckley in a deal valued at up to $3.8…

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ADAP Crisis Task Force Strikes Deal to Widen Access to New HIV Pill

Merck has partnered with the ADAP Crisis Task Force to expand access…

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Harbour BioMed Announces NMPA Acceptance for the Treatment of Advanced Solid Tumors

Harbour BioMed has announced that China’s National Medical Products Administration (NMPA) has…

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ImmunityBio Signs Exclusive U.S. Agreement with Japan BCG Laboratory to Expand BCG Supply in the United States

ImmunityBio has signed an exclusive U.S. development and supply agreement with Japan…

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FDA Grants Priority Review for GSK’s Bepirovirsen for Chronic Hepatitis B

The FDA has granted Priority Review to GSK’s bepirovirsen for chronic hepatitis…

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FDA accepts application for Roche’s Gazyva/Gazyvaro for the treatment of the most common form of lupus

The FDA has accepted Roche’s supplemental application for Gazyva/Gazyvaro as a treatment…

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Philips receives FDA 510(k) clearance for its Rembra platform

Philips has received FDA 510(k) clearance for its Rembra platform, including Rembra…

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