Drug Approval | June 23, 2022
Menarini Group and Radius Health submit new drug application to the USFDA for Elacestrant
Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients
Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients
Avillion announces expansion of partnership with AstraZeneca on PT027 and will fund and execute a new Phase 3b study
The companies expect to complete the submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression is anticipated in the first half of 2023
AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS).
The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022
The supplemental adolescent approval enhances Solosec’s strong position as the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV
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In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed in 2020
Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU
Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD
Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)
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