USFDA

AbbVie, a  research-based biopharmaceutical company, has been granted breakthrough therapy designation  to Venetoclax by the US FDA for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation.

The US Food and Drug Administration (FDA) has approved Roche's cobas KRAS mutation test for diagnostic use. The real-time PCR test is designed to identify KRAS mutations in tumour samples from metastatic colorectal cancer (mCRC) patients and aid clinicians in determining a therapeutic path for them.

Nevro Corp., a medical device company focused on developing solutions in the neuromodulation spacea, has received approval from the United States Food and Drug Administration (FDA) for its Senza spinal cord stimulation (SCS) system. This is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.

The US Food and Drug Administration (FDA) has accepted request by Biogen and AbbVie's Biologics License Application (BLA) for marketing approval of Zinbryta (daclizumab high-yield process) for the  treatment of multiple sclerosis (MS).

aTyr Pharma, a biotherapeutics company engaged in the discovery and development of physiocrine-based therapeutics to address rare diseases, announced  that Resolaris has been granted Orphan Drug designation by the US Food and Drug Administration (FDA) for the treatment of facioscapulohumeral muscular dystrophy (FSHD).  Resolaris, an investigational new drug,  is being developed as a first-in-class intravenous protein therapeutic for the treatment of rare myopathies with an immune component.

Three Indian pharmaceutical companies, namely Alembic Pharmaceuticals, Hetero Labs and Torrent Pharmaceuticals have get the US Food and Drug Administration (FDA) approval for generic versions of Abilify (aripiprazole). Aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder.   Teva Pharmaceuticals has also get  similar approval.

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United States Food and Drug Administration (FDA) has approved a revision to the duration of the bolus delivery for the Aggrastat (tirofiban HCl) high-dose bolus (HDB) regimen launched by Medicure Inc, a specialty pharmaceutical company. Aggrastat is Antiplatelet drug. It is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).

Syneron Medical Ltd. (NASDAQ: ELOS), a global market leader in the aesthetic medical device marketplace, announced today that the PicoWay® picosecond laser received U.S. Food and Drug Administration (FDA) clearance for the treatment of pigmented lesions.

AstraZeneca, a global, innovation-driven biopharmaceutical business,  announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for the MEK inhibitor selumetinib, for the treatment of uveal melanoma.

Sandoz, a global leader in generic pharmaceuticals and a  subsidiary of Novartis, has received approval from the US Food and Drug Administration (FDA) for Glatopa. Glatopa is the first FDA-approved, substitutable generic version of Copaxone^® 20mg, a treatment for relapsing forms of multiple sclerosis. Sandoz, together with Momenta, is proud to be the first company to receive FDA approval for a substitutable generic version of this important therapy.