
Bevespi Aerosphere is a twice-daily, fixed-dose dual bronchodilator.
Bevespi Aerosphere is a twice-daily, fixed-dose dual bronchodilator.
The FDA has approved AstraZeneca's glycopyrrolate and formoterol fumarate (Bevespi Aerosphere) inhalation aerosol for long-term maintenance treatment for patients with chronic obstructive pulmonary disease.
The FDA has approved Exelixis' cabozantinib (Cabometryx) as a treatment for advanced renal cell carcinoma patients who have received antiangiogenic therapy.
The FDA has granted breakthrough therapy designation to nivolumb (Opdivo) as a potential treatment for recurrent or metastatic squamous cell carcinoma of the head and neck after platinum-based therapy.
Radiofrequency ablation therapy can remove diseased esophageal tissue while minimizing damage to the healthy surrounding tissue.
Medtronic has launched a new product to help patients with Barrett's esophagus: the Barrx 360 Express radiofrequency ablation balloon catheter.
Approval was sought for octreotide (Mycapssa) capsules for the maintenance treatment of adults with acromegaly.
Chiasma told it had not provided enough evidence of the drug’s efficacy to warrant an approval.
The FDA has rejected Chiasma Inc's octreotide (Mycapssa) capsules for the maintenance treatment of adults with acromegaly.
Pharmakon Pharmaceuticals Inc voluntarily recalls sterile compounded products due to sterility and quality concerns.
Pharmakon Pharmaceuticals Inc is voluntarily recalling all lots of its sterile compounded products due to sterility and quality concerns.
Baxter is currently the only manufacturer to offer the antibiotic in a premixed presentation.
Baxter International Inc has launched a ready-to-use version of Vancomycin injection.
The FDA has accepted for review Merck's biologics license application for a dust mite sublingual allergy immunotherapy tablet.
The FDA is disputing the efficacy of Nubreed Nutrition's dietary supplement called Undisputed.
New dosage strengths of the generic version of Novartis' Lopressor treats conditions such as cardiogenic shock, overt cardiac failure, and severe peripheral arterial circulatory disorders.
Mylan has launched new dosage strengths of the generic version of Novartis' Lopressor.
The FDA has approved venetoclax (Venclexta) as a treatment for certain patients with chronic lymphocytic leukemia.
Entresto found to benefit clinically stable heat failure patients as much as the least-stable patients.
Novartis' sacubitril/valsartan (Entresto) is showing promise for heart failure patients with reduced ejection fraction, regardless of background therapy or clinical stability.
Valganciclovir treats cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome.
Aurobindo Pharma Limited has received final approval from the FDA to launch valganciclovir tablets USP, 450 mg, which are therapeutically equivalent to Hoofman-LaRoche's Valcyte.
The FDA has approved venetoclax (Venclexta) as a treatment for certain patients with chronic lymphocytic leukemia.
Lamivudine is designed to treat HIV-1 infection in combination with other antiretroviral agents.
Lamivudine is a nucleoside analogue reverse transcriptase inhibitor designed to treat HIV-1 infection in combination with other antiretroviral agents.
Mylan has launched lamivudine tablets USP, 150 mg and 300 mg, which are the equivalent of ViiV Healthcare's Epivir tablets.
Pacemaker is intended for patients with atrial fibrillation or other dangerous arrhythmias, such as bradycardia-tachycardia syndrome.
The FDA has approved the first leadless pacemaker: Medtronic's Micra Transcatheter Pacing System.
The FDA has approved infliximab-dyyb (Inflectra), which is a biosimilar to Janssen Biotech Inc's infliximab (Remicade).
The FDA has approved Gilead Sciences' emtricitabine 200 mg/tenofovir alafenamide 25 mg (Descovy), a treatment for HIV.