Category archives for: FDA News

FDA Approves Besponsa (inotuzumab ozogamicin) for Relapsed or Refractory Acute Lymphoblastic Leukemia

August 17, 2017 — The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). “For adult patients with B-cell…

Healthy Breakfasts for Kids: It's All About Balance

Healthy breakfasts are a must for kids and help keep them going strong all day. This article and short video provide tips on making it happen.

May 23 Webinar on Hearing Aids: The Basic Information You Need to Know

In this webinar, FDA audiologist Sue-Chen Peng, Ph.D., offers consumers basic information on hearing loss and hearing aids.

5 Tips for Traveling to the U.S. With Medications

Can you bring foreign drugs into the U.S.? Or refill a foreign prescription at a U.S. pharmacy? The U.S. Food and Drug Administration can help you understand the rules for flying with medications or shipping them from overseas.

CMP Pharma, Inc. Announces FDA Approval of CaroSpir (spironolactone) Oral Suspension

Farmville, NC. August 7, 2017 – CMP Pharma today announced that the US Food and Drug Administration (FDA) has granted final approval of the company’s New Drug Application (NDA) for CaroSpir (Spironolactone Oral Suspension, 25 mg/5mL), the first…

FDA Approves Vyxeos (daunorubicin and cytarabine) Liposome for Injection for Certain Types of Poor-Prognosis Acute Myeloid Leukemia

August 3, 2017 — The U.S. Food and Drug Administration today approved Vyxeos for the treatment of adults with two types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes…

Should You Put Sunscreen on Infants? Not Usually

For infants under age 6 months, it’s best to cover them up and keep them well shaded. An FDA pediatrician tells how to protect babies from dangerous ultraviolet rays.

FDA Approves Imbruvica (ibrutinib) for Chronic Graft Versus Host Disease

August 2, 2017 — The U.S. Food and Drug Administration today expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the…

FDA Approves Idhifa (enasidenib) for Relapsed or Refractory Acute Myeloid Leukemia with IDH2 Mutation

August 1, 2017 — The U.S. Food and Drug Administration today approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for…

FDA Expands Approval of Yervoy (ipilimumab) to Include Pediatric Patients 12 Years and Older with Unresectable or Metastatic Melanoma

PRINCETON, N.J.–(BUSINESS WIRE) July 24, 2017 –Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has expanded the indication for Yervoy (ipilimumab) injection for intravenous use to now…

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