The FDA has accepted for review the supplemental New Drug Application (sNDA) for sacubitril/valsartan (Entresto; Novartis) in the treatment of heart failure with preserved ejection fraction. The Food ...

The FDA approved a new generic of valsartan Feb. 12 to help relieve the shortage of the critical blood pressure drug that resulted from a string of recent recalls. Since last summer, several ...

A few years ago India’s Alkem Laboratories was in the hot seat with the FDA, having had several plants cited by inspectors. Today it is in the driver’s seat after the agency approved its new generic ...

In HF patients, ARBs and ACE inhibitors should be used according to current guidelines, recognizing the increasing evidence that these drugs might exert some beneficial effects through a reduction in ...

Sacubitril/valsartan may be a better treatment option compared with ACEi/ARBs for patients with malignant hypertension-associated thrombotic microangiopathy. Kidney recovery is better when thrombotic ...

A New Jersey federal judge on Friday tossed out consumers' fraud claims against distributors of generic valsartan blood pressure drugs but waved through allegations against manufacturers themselves. U ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

PHILADELPHIA — Further analyses of the PARADIGM and PARAGON heart failure trials of sacubitril/valsartan (Entresto, Novartis) appear to show that the benefits of the drug combination established in ...

When two generic drug makers scrambled last July to recall hundreds of lots of the blood pressure-lowering drug valsartan, a third company unaffected by the recall saw a "one-off opportunity" to ...