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Zacks News
ObsEva's (OBSV) Yselty Gets EU Nod to Treat Uterine Fibroids
by Zacks Equity Research
ObsEva's (OBSV) Yselty receives its first marketing approval in the European Union for the treatment of uterine fibroids in adult women. Shares were up 11% in pre-market trading following the news.
Clovis (CLVS) Up 19.4% on Upbeat Data From Solid Tumor Study
by Zacks Equity Research
Clovis Oncology (CLVS) reports favorable data from a study, which supports the potential clinical utility of FAP-2286, its targeted radiotherapy candidate, as a treatment for advanced solid tumors.
FDA Committee Endorses bluebird's (BLUE) Thalassemia Therapy
by Zacks Equity Research
An FDA advisory committee favors approval for bluebird bio's (BLUE) beti-cel to treat transfusion-dependent thalassemia. A final decision by the regulatory body is expected on Aug 19, 2022.
FDA Committee Recommends bluebird's (BLUE) CALD Therapy
by Zacks Equity Research
An FDA advisory committee supports approving bluebird bio's (BLUE) eli-cel for treating cerebral adrenoleukodystrophy. NASDAQ halts trading BLUE's common stock on Jun 9 and 10.
bluebird (BLUE) Up as FDA Nod Likely for Thalassemia Therapy
by Zacks Equity Research
Based on briefing documents issued by the FDA, a positive regulatory approval is expected on bluebird bio's (BLUE) gene-therapy for treating thalassemia.
AstraZeneca (AZN) Breast Cancer Drug Cuts Risk of Death to Half
by Zacks Equity Research
Data from a late-stage study shows that AstraZeneca's (AZN) Enhertu meets superior and clinically meaningful progression-free survival and overall survival in HER2-low metastatic breast cancer patients.
BioMarin (BMRN) Delays FDA Re-Submission for Hemophilia Drug
by Zacks Equity Research
BioMarin (BMRN) posts follow-up data from a phase I/II study on its gene-therapy candidate for hemophilia A. However, the stock falls 7% as management plans to defer the candidate's BLA filing.
Amicus' (FOLD) Galafold Aids Growth, Overdependence a Woe
by Zacks Equity Research
Currently, Amicus Therapeutics (FOLD) has only one marketed product in its portfolio, the Fabry disease drug Galafold. The FDA is reviewing FOLD's filings that seek approval for Pompe disease.
Verrica (VRCA) Down 64% as Molluscum Drug Gets CRL From FDA
by Zacks Equity Research
Verrica Pharmaceuticals' (VRCA) new drug application for VP-102 to treat molluscum contagiosum faces rejection from the FDA for a second time.
Aerie (AERI) Starts Late-Stage Study to Treat Dry Eye Disease
by Zacks Equity Research
Aerie Pharmaceutials (AERI) doses the first patient in a phase III study on its investigational TRMP8 agonist drug for the treatment of dry eye disease.