Tyrvaya (varenicline) is a prescription drug that’s used to treat dry eye disease in adults. The drug comes as a nasal spray. It’s typically used twice per day. Tyrvaya comes as a nasal spray ...

Ibsrela (tenapanor) is a prescription drug used to treat irritable bowel syndrome with constipation (IBS-C) in adults. The drug comes as an oral tablet. It’s typically taken twice per day.

If a drug product is listed as discontinued in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book"), the manufacturer will also need to ask FDA if the drug ...

Bevespi Aerosphere (glycopyrrolate/formoterol fumarate) is a brand-name drug prescribed as a maintenance treatment for chronic obstructive pulmonary disease (COPD) in ...

The FTC warned in September that it may consider legal action against companies who list new patents in the Orange Book – or Approved Drug Products with Therapeutic Equivalence Evaluations ...

The Orange Book – or Approved Drug Products with Therapeutic Equivalence Evaluations, as it is otherwise known – is a registry of patents on drug substances, products, and methods of use that ...

Incruse Ellipta is approved by the Food and Drug Administration (FDA) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults. Incruse Ellipta belongs to a drug ...

In February, the U.S. Food and Drug Administration approved Iovance’s TIL therapy, called lifileucel, brand name Amtagvi, for advanced melanoma. Though other T cell–based therapies that ...

The U.K. regulatory authority approved the Alzheimer's disease drug, Leqembi, last month. But the U.K. cost-effectiveness ...

A new anti-osteoporosis drug has just been approved for use in the UK. The drug, called abaloparatide, is licensed for post-menopausal women with osteoporosis and a very high risk of fractures.

Patients may self-inject Nemluvio after receiving training on SC injection technique. The Food and Drug Administration (FDA) has approved Nemluvio ® (nemolizumab-ilto) for the treatment of adults ...