CLINICAL ROLE -
FDA Approves New COPD Maintenance Treatment
Bevespi Aerosphere is a twice-daily, fixed-dose dual bronchodilator.
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New COPD Maintenance Treatment Approved
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.
Renal Cell Carcinoma Treatment Approved
The FDA has approved Exelixis' cabozantinib (Cabometryx) as a treatment for advanced renal cell carcinoma patients who have received antiangiogenic therapy.
Opdivo Granted Breakthrough Therapy Designation for New Indication
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.
Balloon Catheter Launched for Barrett's Esophagus Treatment
Radiofrequency ablation therapy can remove diseased esophageal tissue while minimizing damage to the healthy surrounding tissue.
Balloon Catheter for Barrett's Esophagus Treatment Launched
Medtronic has launched a new product to help patients with Barrett's esophagus: the Barrx 360 Express radiofrequency ablation balloon catheter.
Acromegaly Maintenance Rejected by FDA
Approval was sought for octreotide (Mycapssa) capsules for the maintenance treatment of adults with acromegaly.
FDA Rejects Acromegaly Maintenance Treatment
Chiasma told it had not provided enough evidence of the drug’s efficacy to warrant an approval.
Acromegaly Maintenance Treatment Rejected
The FDA has rejected Chiasma Inc's octreotide (Mycapssa) capsules for the maintenance treatment of adults with acromegaly.
Recall Issued for Sterile Compounded Products
Pharmakon Pharmaceuticals Inc voluntarily recalls sterile compounded products due to sterility and quality concerns.
Sterile Compounded Products from Pharmakon Pharmaceuticals Recalled
Pharmakon Pharmaceuticals Inc is voluntarily recalling all lots of its sterile compounded products due to sterility and quality concerns.
Ready-to-Use Version of Antibiotic Vancomycin Injection Launched
Baxter is currently the only manufacturer to offer the antibiotic in a premixed presentation.
Premix Vancomycin Injection in Sodium Chloride Launched
Baxter International Inc has launched a ready-to-use version of Vancomycin injection.
Dust Mite Allergy Immunotherapy Tablet Under Review
The FDA has accepted for review Merck's biologics license application for a dust mite sublingual allergy immunotherapy tablet.
Dietary Supplement Recalled Due to Presence of Acacia Rigidula
The FDA is disputing the efficacy of Nubreed Nutrition's dietary supplement called Undisputed.
Generic Intermediate Dosage Cardiovascular Drug Launched
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.
First Intermediate Dosage Strengths of Generic Lopressor Launched
Mylan has launched new dosage strengths of the generic version of Novartis' Lopressor.
New Treatment for Chronic Lymphocytic Leukemia Approved
The FDA has approved venetoclax (Venclexta) as a treatment for certain patients with chronic lymphocytic leukemia.
Entresto Offers Hope to Heart Failure Patients
Entresto found to benefit clinically stable heat failure patients as much as the least-stable patients.
Entresto Shows Benefit Even in Clinically Stable Heart Failure Patients
Novartis' sacubitril/valsartan (Entresto) is showing promise for heart failure patients with reduced ejection fraction, regardless of background therapy or clinical stability.
FDA Approves Generic CMV Disease Drug
Valganciclovir treats cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome.
Generic Valcyte Receives Approval
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.
Mylan Launches Generic HIV Treatment
Lamivudine is designed to treat HIV-1 infection in combination with other antiretroviral agents.
Generic HIV Drug Launched
Lamivudine is a nucleoside analogue reverse transcriptase inhibitor designed to treat HIV-1 infection in combination with other antiretroviral agents.
Generic Version of Epivir Launched
Mylan has launched lamivudine tablets USP, 150 mg and 300 mg, which are the equivalent of ViiV Healthcare's Epivir tablets.
FDA Approves First Leadless Pacemaker
Pacemaker is intended for patients with atrial fibrillation or other dangerous arrhythmias, such as bradycardia-tachycardia syndrome.
First Leadless Pacemaker Approved
The FDA has approved the first leadless pacemaker: Medtronic's Micra Transcatheter Pacing System.
Second Biosimilar Approved
The FDA has approved infliximab-dyyb (Inflectra), which is a biosimilar to Janssen Biotech Inc's infliximab (Remicade).
New TAF-Based HIV Treatment Approved
The FDA has approved Gilead Sciences' emtricitabine 200 mg/tenofovir alafenamide 25 mg (Descovy), a treatment for HIV.