The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases
Poviztra is a second brand of Wegovy
The said inspection concluded with Zero Form 483 observation
Syngene International has reported total income of Rs. 926 crore during the period ended September 30, 2025
A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations
Orphan drug designation (ODD) by the USFDA for Desidustat, provides eligibility for a potential seven-year marketing exclusivity subject to the USFDA approval
Senores Pharmaceuticals (SPI) acquired 51% stake in Zoraya Pharmaceuticals
Oral semaglutide 25 mg was associated with the same weight loss efficacy in women with obesity regardless of menopausal stage, and patients reported improvements in physical function, respectively
Cupid has been allocated approximately 23.4 million units of female condoms per year
Exemestane is a key therapeutic used in the treatment of certain types of breast cancer in postmenopausal women
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