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Results For "approval"

2479 News Found

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


Teva reports 11th consecutive quarter of growth
News | November 06, 2025

Teva reports 11th consecutive quarter of growth

Teva reported third quarter revenues of $4.5 billion, an increase of 3 per cent year-over-year.


Akums Drugs gets 20- year patent for
News | November 04, 2025

Akums Drugs gets 20- year patent for "Dual Release Gastro-Resistant Composition"

The company has introduced an innovative Dual Release Proton Pump Inhibitor (PPI) tablet, a next-generation therapy for patients suffering from moderate to severe or treatment resistant gastroesophageal reflux disease


Lilly to build $3 billion oral medicine facility in Netherlands
News | November 04, 2025

Lilly to build $3 billion oral medicine facility in Netherlands

Netherlands site will bring 500 manufacturing and 1,500 construction jobs while further strengthening Lilly's global supply chain


Kimberly-Clark to acquire Kenvue in $48.7 billion mega deal
News | November 04, 2025

Kimberly-Clark to acquire Kenvue in $48.7 billion mega deal

Upon completion, Kimberly-Clark shareholders are expected to own about 54% of the combined entity, while Kenvue shareholders will hold the remaining 46%


EU approves Alexion’s Koselugo to treat adults with neurofibromatosis type 1 tumours
Clinical Trials | October 31, 2025

EU approves Alexion’s Koselugo to treat adults with neurofibromatosis type 1 tumours

Approval based on pivotal KOMET Phase III trial demonstrating significant tumour reduction in adults with NF1


FDA approves Bayer’s Lynkuet as first hormone-free therapy for menopausal hot flashes
Drug Approval | October 29, 2025

FDA approves Bayer’s Lynkuet as first hormone-free therapy for menopausal hot flashes

This approval marks a significant milestone in women’s health, introducing Bayer’s first hormone-free treatment for menopause-related symptoms


FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma
Drug Approval | October 29, 2025

FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma

The Fast Track Designation was supported by nonclinical data as well as clinical results from the ongoing Phase I/IIa trial evaluating the safety and tolerability


Medherant announces positive Phase 1 results of clinical trial of testosterone patch for women
Clinical Trials | October 29, 2025

Medherant announces positive Phase 1 results of clinical trial of testosterone patch for women

Medherant’s testosterone TEPI Patch could become the first-in-class testosterone patch developed specifically for women