News Wire

The FDA has approved three new drugs for type-2 diabetes: Steglatro tablets (ertugliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor; Steglujan tablets (ertugliflozin/sitagliptin), the only fixed-dose combination of an SGLT2 inhibitor and the dipeptidyl peptidase-4 inhibitor sitagliptin;…
The FDA is removing boxed warnings about asthma-related deaths from the labels of drugs that combine long-acting beta agonists (LABAs) with inhaled corticosteroids (ICS) after studies showed such combinations don’t cause more serious asthma-related side effects than ICS treatment alone. However, using…
The FDA has approved pertuzumab (Perjeta, Genetech), in combination with trastuzumab (Herceptin, Genentech) and chemotherapy, for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence. People should receive the adjuvant pertuzumab-based regimen for one year. The FDA also…
Nivolumab (Opdivo, Bristol-Myers Squibb) has secured FDA approval for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. Adjuvant therapy aims to reduce the risk of recurrence following surgical removal of the…
The FDA has approved a new indication for cabozantinib tablets (Cabometyx, Exelixis, Inc.) for treatment of patients with advanced renal cell carcinoma (RCC), the most common form of kidney cancer in adults. The FDA’s priority review and approval were based on results from the randomized phase 2 CABOSUN…
Bosutinib (Bosulif, Pfizer Inc.) is now FDA-approved to treat adults with newly diagnosed chronic-phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). The FDA gave the supplemental new drug application to expand the indication for bosutinib priority review and granted accelerated…
The FDA has approved the gene therapy Luxturna (voretigene neparvovec-rzyl, Spark Therapeutics, Inc.) to treat children and adults with an inherited form of vision loss that may result in blindness. Luxturna is the first directly administered gene therapy approved in the U.S. that targets a disease…
Rates of vaccine exemptions among students in Washington fell significantly after the state required parental counseling, according to a study published online in the journal Pediatrics. “This highlights the importance of more stringent policies for obtaining immunization exemptions,” the authors…
The FDA has approved netarsudil ophthalmic solution, 0.02% (Rhopressa, Aerie Pharmaceuticals, Inc.) for the lowering of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The FDA approval decision came two months ahead of the scheduled Prescription Drug…
Shire has asked a federal court to restrict Roche AG from creating, transporting, and marketing its recently approved hemophilia drug Hemlibra (emicizumab-kxwh, Genentech) in the U.S., according to a BioPharma Dive report. The request came in the form of a motion for preliminary injunction filed with…
Ultragenyx Pharmaceutical, Inc., has agreed to sell its rare pediatric disease priority review voucher (PRV) to Novartis for $130 million. Ultragenyx was awarded the voucher under an FDA program intended to encourage the development of treatments for rare pediatric diseases. The company received the…
These are certainly desperate times when it comes to the nation’s opioid epidemic. It might not be a desperate measure to force addicts into short-term rehabilitation facilities, but it’s getting attention, the Wall Street Journal reports. “In an aggressive, new proposal, Massachusetts authorities…
Adding to a late-in-the year flurry of huge mergers, Ascension and Providence St. Joseph are in talks that would create the largest hospital operator in the country, according to the Wall Street Journal. “A deal would create a new operation of unprecedented reach, with 191 hospitals in 27 states and…
Rapidly dividing aberrant stem cells are a major source of cancer. But a new study suggests that mature cells also play a key role in initiating cancer––a finding that could upend the way scientists think about the origin of the disease. Researchers at Washington University School of Medicine in…
After reviewing the latest research, the FDA has reaffirmed its 2014 warning that power morcellators should rarely be used in gynecological surgery because of the risk of spreading a hidden uterine cancer. According to a report in the Philadelphia Inquirer, the FDA said the latest studies are consistent…

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