CLINICAL ROLE -
FDA Approves Opdivo for Patients with Head and Neck Cancer
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).
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FDA Approves Hepatitis B Drug
Vemlidy treats patients with chronic hepatitis B infection with compensated liver disease.
Vemlidy Approved for Chronic Hepatitis B
Vemlidy is a targeted prodrug of tenofovir for chronic hepatitis B infection with compensated liver disease.
FDA Approves Vemlidy for Treatment of Chronic Hepatitis B in Adults
The FDA has approved Vemlidy (tenofovir alafenamide) from Gilead for the treatment of chronic hepatitis B infection with compensated liver disease.
Phase 2 Trial Launched for Plantar Fasciitis Treatment
DaxibotulinumtoxinA injection assessed for the potential management of plantar fasciitis, which is the most common cause of heel pain.
Revance Begins Phase 2 Trial for RT002 for Plantar Fasciitis Management
Revance has begun its phase 2 placebo-controlled trial for DaxibotulinumtoxinA (RT002) for injection.
Phase 3 Trial Launched for Citrate Anticoagulant
Investigational drug combines a citrate anticoagulant and a renal replacement solution.
Baxter Begins Phase 3 Clinical Trial for Citrate Anticoagulant
Baxter has begun a phase 3 clinical trial for an investigational drug that combines a citrate anticoagulant and a renal replacement solution.
FDA Accepts BLA for Subcutaneous Version of Blood Cancer Drug
Rituximab is a cancer medication that can be used in combination with methotrexate to treat symptoms of adult rheumatoid arthritis.
FDA Accepts BLA for Subcutaneous Formulation of Rituximab
The FDA has accepted the biologics license application from Genentech for a subcutaneous formulation of rituximab for multiple blood cancer indications.
Phase 3 Trial to Evaluate Pimavanserin for Schizophrenia
Pimavanserin analzyed as an adjunctive treatment for schizophrenia
ACADIA Begins Phase 3 Trial to Evaluate Pimavanserin 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.
Priority Review Granted to Breast Cancer Drug
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.
FDA Grants NDA Approval and Priority Review for LEE011
The FDA has accepted Novartis’ New Drug Application (NDA) and granted Priority Review for LEE011 (ribociclib).
Restasis Multidose Gets FDA Approval for Chronic Dry Eye
Restasis Multidose helps patients with chronic dry eye create more of their own tears.
FDA Approves Allergan Restasis Multidose for Chronic Dry Eye
Allergan has received approval from the FDA for Restasis Multidose (cyclosporine ophthalmic emulsion) 0.05% for the treatment of chronic dry eye.
Rheumatoid Arthritis Biosimilar Enters Phase 1 Trial
Orencia is the only CTLA-4lg approved in the United States, European Union, and Japan for the treatment of rheumatoid arthritis.
Phase 1 Clinical Trial Launched for Orencia Biosimilar
Orencia is a fusion protein and the only CTLA-4lg approved in the United States for the treatment of rheumatoid arthritis.
Momenta and Mylan Begin Phase 1 Clinical Trial for Orencia Biosimilar
Momenta and Mylan have announced that dosing has begun in a phase 1 study for M834, the proposed biosimilar of Orencia (abatacept).
Phase 2 Trial Launched for Seizure Medication
FYCOMPA is an adjunctive therapy for partial-onset seizures.
Eisai Begins 2 Phase 3 Trials to Further Assess FYCOMPA
Eisai announced the beginning of 2 multi-center, global phase 3 clinical trials assessing FYCOMPA (perampanel).
FDA Approves Clostridium Difficile Infection Drug
Zinplava is indicated to reduce the recurrence of Clostridium difficile infection in adults receiving an antibacterial drug.
Generic Version of Vagifem Launched
Yuvafem delivers the same low dose of vaginal estrogen in a pre-loaded, single-use, disposable applicator.
Amneal Launches Yuvafem, the Generic Version of Vagifem
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 Grants Support Rare Disease Research
FDA awards grants for new clinical trial research worth more than $23 million over the next 4 years for rare disease drug development.
FDA Awards 21 Grants for Rare Disease Product 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.
FDA Approves Lartruvo for the Treatment of Soft Tissue Sarcoma
The FDA has approved Lilly's Lartruvo (olaratumab injection), in combination with "doxorubicin, for the treatment of soft tissue sarcoma (STS) in adults.
FDA Approves Label Change for Bipolar, Schizophrenia Agitation Drug
Adasuve inhalation powder is the first orally inhaled medication for the acute treatment of agitation associated with bipolar I or schizophrenia.
FDA Approves sNDA for Label Changes to ADASUVE
The FDA has approved the supplemental New Drug Application for label changes to ADASUVE (loxapine) inhalation powder.
Napo Launches Mytesi for Diarrhea Treatment in HIV Patients
Napo has launched Mytesi, (crofelemer) for the treatment of diarrhea in patients with HIV.