The Food and Drug Administration (FDA) has accepted Celgene Corp.'s new drug application for Enasidenib, a treatment for patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase 2 mutation.

The Food and Drug Administration has approved AstraZeneca's Qtern, which is taken to help treat Type 2 diabetes.

A recent SEARCH for Diabetes in Youth study found that teens and young adults with Type 2 diabetes are more likely to develop complications in the years following their diagnosis than their peers with Type 1 diabetes.

A Phase 1 clinical trial to test the safety and tolerability of an investigational vaccine against respiratory syncytial virus has begun at the National Institutes of Health Clinical Center in Bethesda, Maryland.

Physicians have opposed the merger between Aetna and Humana for over a year and a half, trying to challenge the merger by giving the Department of Justice and state attorneys general evidence against the merger.

The U.S. Food and Drug Administration approved AbbVie’s IMBRUVICA for treatment of relapsed/refractory marginal zone lymphoma in patients who require systemic therapy and have received at least one prior anti-CD 20-based therapy.

The U.S. Food and Drug Administration recently reminded medical professionals nationwide that effective this week, the majority of powdered medical gloves will be banned from use following its regulation passed in December 2016.

In a revised approach to its plan with Arena Pharmaceuticals Inc. dating to November 2013, Eisai Inc. recently agreed to purchase all development and marketing rights for Arena’s weight loss treatment medication, lorcaserin hydrochloride CIV.

Advising health care facilities nationwide of possible safety defects in battery-operated mobile medical carts, the U.S. Food and Drug Administration recently issued a warning accompanied by guidance from its headquarters in Silver Spring, Maryland.

Alere Forensics at Redwood Toxicology Laboratory, the forensics division of Alere, has received accreditation from the American Board of Forensic Toxicology.

New Yorkers now have protection against health risks caused by Step Therapy/Fall First Therapy after Gov. Andrew Cuomo signed new legislation into law.

Adynovate by Shire was approved by the U.S. Food and Drug Administration last week for the treatment for hemophilia A in children under 12 years old and for use in surgical settings for both adult and pediatric patients.

The American Academy of Family Physicians sent a letter to UnitedHealthcare expressing its concerns with the insurer's practice of sending out nurses to provide care without coordinating with the primary care physician.

Authorizing the nation’s first injectable drug targeting the rare, lethal disease of spinal muscular atrophy, the U.S. Food and Drug Administration recently approved Spinraza (nusinersen) as a treatment for both children and adults.

Pfizer Inc.'s IBRANCE supplemental New Drug Application was accepted by the U.S. Food and Drug Administration last week.

The U.S. Food and Drug Administration has approved marketing of a tissue expander system designed for the expansion of soft tissue in two-stage breast reconstruction after a mastectomy as well as for the treatment of breasts that are underdeveloped and deformities in soft tissue.

A regulatory application for belimumab was submitted to the Japanese Ministry of Health, Labor and Welfare by British pharmaceutical company GlaxoSmithKline for the treatment of active, autoantibody-positive systemic lupus erythematosus in patients who have not found adequate response after standard therapy.

Marketing authorization for REKOVELLE (follitropin delta) was granted this month by Ferring Pharmaceuticals.

The EMA Committee for Medicinal Products for Human Use (CHMP) holds a positive opinion regarding Keytruda (pembrolizumab), which is designed to treat metastatic non-small cell lung cancer.

Eisai Inc. and Arena Pharmaceutical recently announced that Belviq, developed by Eisai subsidiary Eisai Laboratories, has been given regulatory approval by the Brazilian Health Surveillance Agency (ANVISA).