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- Read more about US FDA granted Nevro's Senza spinal cord stimulation system
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.
- Read more about Biogen & AbbVie want approval by US FDA marketing for Zinbryta to treat multiple sclerosis
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).
- Read more about aTyr Pharma's Resolaris receives US FDA orphan drug status to treat FHSD
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.
- Read more about Indian pharma companies received US FDA marketing nod for generic aripiprazole
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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- Read more about Expanded dosing time & modification in label for Medicure's Aggrastat approved by USFDA
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).
- Read more about Syneron Medical's PicoWay picosecond laser approved by USFDA to treat pigmented lesions
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.
- Read more about AstraZeneca's selumetinib get US FDA orphan drug status for uveal melanoma treatment
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.
- Read more about Sandoz generic Copaxone get US FDA approval for to treat relapsing forms of multiple sclerosis
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.
- Read more about Exelixis’ cabozantinib received Fast Track designation by US FDA for RCC treatment
The US Food & Drug Administration (FDA) has granted Fast Track designation to Exelixis, Inc's cabozantinib for treatment of patients with advanced renal cell carcinoma (RCC). Cabozantinib is the Exelixis' lead compound . Exelixis, Inc. is a biopharmaceutical company committed to developing small molecule therapies for the treatment of cancer.
- Read more about US FDA approved indication for Ethicon’s EVARREST Fibrin Sealant Patch
Ethicon, a part of J&J, received expanded FDA indication for its EVARREST Fibrin Sealant Patch to be used to help control bleeding during adult liver surgeries. The device is bioabsorbable and contains human thrombin and fibinogen proteins that participate in clot formation. It retains its strength and stickiness while it’s still around. EVARREST is a novel convergence of biologics and medical device that rapidly and reliably stops problematic bleeding during surgery on the first attempt in indicated patients. EVARREST is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis . The unmatched mechanism of action behind EVARREST drives rapid and durable clot formation. The technology is comprised of a flexible composite patch, which contains embedded human biologics (human thrombin and fibrinogen), which are proteins involved in the natural clotting process.