Tag: FDA

U.S Food and Drug Administration (FDA)

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…

Harshad Hussain B

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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FDA Grants Breakthrough Therapy Designation to Novartis’ Ianalumab for Sjögren’s Disease

The FDA has granted Breakthrough Therapy designation to Novartis’ ianalumab for Sjögren’s…

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The SFDA CEO Receives Syrian Minister of Health to Discuss Joint Cooperation

H.E. the CEO of the Saudi Food and Drug Authority (SFDA), Dr.…

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Lilly to acquire Verve Therapeutics to advance one-time treatments for people with high cardiovascular risk

Eli Lilly and Company and Verve Therapeutics, Inc., a Boston-based clinical-stage company…

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FDA grants accelerated approval to Novartis’ Vanrafia® for IgA Nephropathy treatment

Basel- April 2025- Novartis announced the US Food and Drug Administration (FDA)…

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Hera Health Solutions wins Arab Health’s Innov8 competition, securing US$10,000 top prize

Dubai, United Arab Emirates- 30 January 2025: Hera Health Solutions has won…

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