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Eisai’s Thyroid Cancer Drug Receives Early FDA Approval

The US Food and Drug Administration (FDA) has granted an early approval to Eisai’s drug for the most common form of thyroid cancer. The agency announced that it has approved the Japanese drugmaker’s Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive …

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Ignyta’s Lung Cancer Drug Receives Orphan Drug Status from the FDA

Today, precision oncology biotechnology company Ignyta, Inc. announced that its lead candidate has been granted orphan drug designation from US health regulators. According to the company, the US Food and Drug Administration (FDA) granted Ignyta’s entrectinib orphan drug designation for the treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive and ALK-positive non-small …

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Pfizer’s Breast Cancer Drug Receives Accelerated Approval from the FDA

Federal health regulators have provided an early approval to Pfizer Inc.’s Breakthrough breast cancer drug palbociclib. The company announced that the US Food and Drug Administration (FDA) has granted accelerated approval of Ibrance (palbociclib) in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth …

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FDA Approves Glyxambi for Patients with Type 2 Diabetes

US health regulators have approved a first-of-its-kind diabetes treatment, which combines two existing drugs in one tablet. The US Food and Drug Administration (FDA) has approved Eli Lilly and Co and Boehringer Ingelheim Pharmaceuticals’ Glyxambi (empagliflozin/linagliptin) tablets, as an adjunct to diet and exercise to improve glycemic control in adults …

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Genentech’s Investigational Monoclonal Antibody Granted Breakthrough Status for Treatment of Lung Cancer

US-based Genentech recently announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its investigational cancer immunotherapy. The agency granted the designation to Genentech’s MPDL3280A for treatment of patients with Programmed Death-Ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) whose disease has progressed during …

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PARI’s Electronic Nebulizer Receives FDA Approval for Cystic Fibrosis Patients

The US Food and Drug Administration (FDA) has approved the first electronic nebulizer to deliver cystic fibrosis patients their therapy. The agency approved PARI’s eRapid nebulizer system to deliver Genentech’s Pulmozyme (dornase alfa [recombinant human DNase] for treatment of cystic fibrosis (CF). According to PARI, eRapid cuts the average treatment …

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Insys’ Ovarian Cancer Treatment Receives Orphan Drug Designation from the FDA

The US Food and Drug Administration (FDA) granted Orphan Drug designation for Insys Therapeutics’ ovarian cancer candidate. The agency granted the designation to Insys’ Liposomal Encapsulated Paclitaxel (LEP) candidate for the treatment of ovarian cancer. The FDA’s Office of Orphan Products Development grants novel drugs or biologics that treat rare …

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Shire Gains as FDA Approves NPS Pharma’s Endocrine Disorder Drug

On Friday, the US Food and Drug Administration (FDA) approved NPS Pharmaceuticals’ rare endocrine disorder drug Natpara (parathyroid hormone), justifying Shire’s $5.2 billion acquisition of the company. The agency approved NPS’ Natpara to control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism, a rare disease that affects approximately 60,000 …

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