Krystle Vermes

The FDA has approved Opdivo (nivolumab) by Bristol-Myers Squibb for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).

Vemlidy treats patients with chronic hepatitis B infection with compensated liver disease.

Vemlidy is a targeted prodrug of tenofovir for chronic hepatitis B infection with compensated liver disease.

The FDA has approved Vemlidy (tenofovir alafenamide) from Gilead for the treatment of chronic hepatitis B infection with compensated liver disease.

DaxibotulinumtoxinA injection assessed for the potential management of plantar fasciitis, which is the most common cause of heel pain.

Revance has begun its phase 2 placebo-controlled trial for DaxibotulinumtoxinA (RT002) for injection.

Investigational drug combines a citrate anticoagulant and a renal replacement solution.

Baxter has begun a phase 3 clinical trial for an investigational drug that combines a citrate anticoagulant and a renal replacement solution.

Rituximab is a cancer medication that can be used in combination with methotrexate to treat symptoms of adult rheumatoid arthritis.

The FDA has accepted the biologics license application from Genentech for a subcutaneous formulation of rituximab for multiple blood cancer indications.

Pimavanserin analzyed as an adjunctive treatment for schizophrenia

ACADIA has announced that it has begun ENHANCE-1, a phase 3 study designed to evaluate pimavanserin as an adjunctive treatment for schizophrenia.

Ribociclib seeks approval as a first-line treatment of postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer.

The FDA has accepted Novartis’ New Drug Application (NDA) and granted Priority Review for LEE011 (ribociclib).

Restasis Multidose helps patients with chronic dry eye create more of their own tears.

Allergan has received approval from the FDA for Restasis Multidose (cyclosporine ophthalmic emulsion) 0.05% for the treatment of chronic dry eye.

Orencia is the only CTLA-4lg approved in the United States, European Union, and Japan for the treatment of rheumatoid arthritis.

Orencia is a fusion protein and the only CTLA-4lg approved in the United States for the treatment of rheumatoid arthritis.

Momenta and Mylan have announced that dosing has begun in a phase 1 study for M834, the proposed biosimilar of Orencia (abatacept).

FYCOMPA is an adjunctive therapy for partial-onset seizures.

Eisai announced the beginning of 2 multi-center, global phase 3 clinical trials assessing FYCOMPA (perampanel).

Zinplava is indicated to reduce the recurrence of Clostridium difficile infection in adults receiving an antibacterial drug.

Yuvafem delivers the same low dose of vaginal estrogen in a pre-loaded, single-use, disposable applicator.

Amneal has launched the first-to-market generic version of Vagifem, being sold as Yuvafem. The 10-mcg estradiol vaginal inserts were shipped to distributors and wholesalers beginning on Oct. 17, 2016.

FDA awards grants for new clinical trial research worth more than $23 million over the next 4 years for rare disease drug development.

The FDA has awarded 21 grants for new clinical trial research worth more than $23 million to be spent over the next 4 years on the development of products for patients with rare diseases.

The FDA has approved Lilly's Lartruvo (olaratumab injection), in combination with "doxorubicin, for the treatment of soft tissue sarcoma (STS) in adults.

Adasuve inhalation powder is the first orally inhaled medication for the acute treatment of agitation associated with bipolar I or schizophrenia.

The FDA has approved the supplemental New Drug Application for label changes to ADASUVE (loxapine) inhalation powder.

Napo has launched Mytesi, (crofelemer) for the treatment of diarrhea in patients with HIV.