Drug Approval | November 21, 2023
GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia
Decision on EU marketing authorisation expected for momelotinib by early 2024
Decision on EU marketing authorisation expected for momelotinib by early 2024
The countrywide initiative aims to spread awareness, educate the public & ensure that no one is left behind in the fight against respiratory diseases
Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone
XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy in nonmetastatic castration-sensitive prostate cancer
This product will be manufactured at Lupin’s Pithampur facility in India
The companies plan to start a pivotal Phase 3 trial in the coming months
In the Phase 3 LIBRETTO-431 study, Retevmo more than doubled progression-free survival (PFS) compared to chemotherapy plus pembrolizumab in patients with advanced or metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC)
Short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)
Approval of oral, once-daily VELSIPITY based on favorable safety and efficacy data from the ELEVATE UC Phase 3 trials
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GenWorks Health Introduces Braster Pro for breast screening & EVA for cervical screening in rural areas & communities
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