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Results For "Food-and-Drug-Administration"

1255 News Found

Sovato secures series B funding to advance remote robotic surgery platform
Medical Device | November 07, 2025

Sovato secures series B funding to advance remote robotic surgery platform

The company plans to use the funds to enhance its technology and forge new strategic partnerships with surgical robotics companies


Senores Pharma forms new subsidiary in US
News | November 06, 2025

Senores Pharma forms new subsidiary in US

Senores Pharmaceuticals (SPI) acquired 51% stake in Zoraya Pharmaceuticals


FDA approves UCB’s Kygevvi for rare genetic mitochondrial disease TK2 deficiency
Drug Approval | November 06, 2025

FDA approves UCB’s Kygevvi for rare genetic mitochondrial disease TK2 deficiency

Kygevvi combines two pyrimidine nucleosides, doxecitine and doxribtimine, which act by integrating deoxycytidine and deoxythymidine into skeletal muscle mitochondrial DNA


Zydus receives FDA’s tentative approval for Budesonide delayedrelease capsules, 4 mg
Drug Approval | November 05, 2025

Zydus receives FDA’s tentative approval for Budesonide delayedrelease capsules, 4 mg

Budesonide is indicated for mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in adults and children 8 years of age and olde


Roche’s Gazyva shows breakthrough efficacy in phase III lupus study
Clinical Trials | November 04, 2025

Roche’s Gazyva shows breakthrough efficacy in phase III lupus study

The ALLEGORY study demonstrated statistically significant improvements in key measures, including British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response


BMS’ Cobenfy sees steady start, eyes stronger growth ahead
News | October 31, 2025

BMS’ Cobenfy sees steady start, eyes stronger growth ahead

Cobenfy generated $43 million in third-quarter sales, up from $35 million in the second quarter


Aldeyra refocuses pipeline on next-gen RASP modulators despite positive phase II success
Clinical Trials | October 31, 2025

Aldeyra refocuses pipeline on next-gen RASP modulators despite positive phase II success

ADX-248, which replaces ADX-743, is being developed for the treatment of metabolic inflammation, including obesity and hypertriglyceridemia


FDA issues warning letter to Philips over manufacturing and quality system deficiencies
Medical Device | October 31, 2025

FDA issues warning letter to Philips over manufacturing and quality system deficiencies

The FDA’s review also revealed delays in Philips’ internal investigations, with 54 inquiries failing to meet targeted completion dates—23 of which were delayed by more than 100 days