7 recent drug, device approvals

Seven drugs and medical devices approved by the FDA since Nov. 21:

  1. leva is Renovia's device designed to strengthen pelvic floor muscles to treat urinary incontinence in women.

  2. Oxbryta, the second ever drug approved to treat sickle cell disease, is made by Global Blood Therapeutics for patients 12 years and older.

  3. TULA system is Tusker Medical's device that is inserted in the eardrum to treat recurrent ear infections. It is the first ear tube delivery system that can be used in young children using local anesthesia in a physician's office.

  4. IN.PACT AV is Medtronic's device, designed for patients with end-stage renal disease, to receive longer periods of uninterrupted dialysis.

  5.  Xcopri is SK Life Science's drug designed to treat partial-onset seizures in adults.

  6. Calquence is AstraZeneca's drug designed to treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma.

  7. Givlaari is Alnylam's $575,00 drug, the first designed to treat acute hepatic porphyria, a rare genetic disorder.  

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Seven drugs and medical devices approved by the FDA since Nov. 21:

leva is Renovia's device designed to strengthen pelvic floor muscles to treat urinary incontinence in women.

 

Oxbryta, the second ever drug approved to treat sickle cell disease, is made by Global Blood Therapeutics for patients 12 years and older.

 

TULA system is Tusker Medical's device that is inserted in the eardrum to treat recurrent ear infections. It is the first ear tube delivery system that can be used in young children using local anesthesia in a physician's office.

 

IN.PACT AV is Medtronic's device, designed for patients with end-stage renal disease, to receive longer periods of uninterrupted dialysis.

 

Xcopri is SK Life Science's drug designed to treat partial-onset seizures in adults.

 

Calquence is AstraZeneca's drug designed to treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma.

 

Givlaari is Alnylam's $575,00 drug, the first designed to treat acute hepatic porphyria, a rare genetic disorder.

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