FDA News

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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FDA and EC Approve Novartis’ Psoriasis Drug Cosentyx

The US Food and Drug Administration (FDA) and the European Commission (EC) approved Novartis’ biologic Cosentyx (secukinumab) as a treatment for psoriasis. Today, Novartis announced that it has received FDA-approval and recently received EU approval for the drug, making it the first drug in the interleukin-17A (IL-17A) inhibitor class to …

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FDA Grants Fast Track Status to Marathon’s Duchenne Muscular Dystrophy Drug

Marathon Pharmaceuticals’ investigational Duchenne Muscular Dystrophy (DMD) drug was granted Fast Track designation by US health regulators. The rare-disease focused biopharmaceutical company recently announced that the US Food and Drug Administration (FDA) granted fast track status for its deflazacort for treatment of patients with DMD, a fatal muscle disease found …

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