Nearly four years after differences between U.S. and Russian clinical results derailed an NDA for its pregnancy prevention candidate, Phexxi, San Diego-based Evofem Biosciences Inc. has prevailed, winning FDA approval today for the vaginal pH regulator.
Unpredictable and unaffordable copays for insulin could be a thing of the past for millions of people enrolled in certain Medicare Part D prescription drug plans.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abivax, Akeso, Algernon, Alnylam, Aurinia, Cytrx, Expression, Hansa, Kala, Neurobo, Novaremed, Orphazyme, Qurient, Rockwell, Sino, Takeda, Zealand.
Sunovion Pharmaceuticals Inc.’s apomorphine sublingual film (APL-130277), a dopamine agonist the company will market as Kynmobi, has won FDA approval for the acute intermittent treatment of motor fluctuations (off episodes) associated with Parkinson’s disease.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Astrazeneca, Beigene, Bluebird, BMS, Daiichi, Evofem, Geron, Intercept, Orphazyme, Sunovion.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akari, Alethia, Anavex, Appili, Astellas, Calcimedica, Chiesi, Fibrogen, Genexine, I-Mab, Passage Bio.
Just days after Clovis Oncology Inc.'s Rubraca (rucaparib) became the first PARP inhibitor approved by the FDA to treat certain cases of metastatic prostate cancer (mCPRC) in third-line care, the agency granted an even broader label in the indication to its first-in-class competitor, Lynparza (olaparib). Endorsement of second-line use of Lynparza in mCPRC and an overall survival (OS) benefit listed in its updated label will help rapidly establish it as "the drug of choice in the [second] line, leaving little commercial opportunities for Rubraca downstream," SVB Leerink analyst Andrew Berens said.
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