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 Chinaโ€™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 GSKโ€™s Bepirovirsen for Chronic Hepatitis B

The FDA has granted Priority Review to GSKโ€™s bepirovirsen for chronic hepatitis…

Harshad Hussain B

FDA accepts application for Rocheโ€™s Gazyva/Gazyvaro for the treatment of the most common form of lupus

The FDA has accepted Rocheโ€™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 Novartisโ€™ Ianalumab for Sjรถgrenโ€™s Disease

The FDA has granted Breakthrough Therapy designation to Novartisโ€™ ianalumab for Sjรถgrenโ€™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 Novartisโ€™ Vanrafiaยฎ 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 Healthโ€™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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