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RSS Channel: Rxmed - New Drug Approvals
New drug approvals news from Rxmed. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.
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FDA Approves Defitelio (defibrotide sodium) for Hepatic Veno-Occlusive Disease Following Hematopoietic Stem-Cell Transplantation
March 30, 2016 -- The U.S. Food and Drug Administration today approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities after they receive a...

FDA Approves Cinqair (reslizumab) to Treat Severe Asthma
March 23, 2016 -- The U.S. Food and Drug Administration today approved Cinqair (reslizumab) for use with other asthma medicines for the maintenance treatment of severe asthma in patients aged 18 years and older. Cinqair is approved for patients who...

FDA Approves Taltz (ixekizumab) for Plaque Psoriasis
March 22, 2016 -- The U.S. Food and Drug Administration today approved Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis. Psoriasis is a skin condition that causes patches of skin redness and flaking. Psoriasis is an...

FDA Approves Anthim (obiltoxaximab) for Inhalation Anthrax
March 21, 2016 -- On Friday, March 18, the U.S. Food and Drug Administration approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Anthim is also approved to prevent inhalational...

FDA Approves Bayer's Kovaltry (Antihemophilic Factor (Recombinant)) for the Treatment of Children and Adults with Hemophilia A
WHIPPANY, N.J., March 17, 2016 /PRNewswire/ -- The U.S. Food and Drug Administration has approved Bayer's Kovaltry Antihemophilic Factor (Recombinant), an unmodified, full-length factor VIII compound for the treatment of hemophilia A in children and...

FDA Grants Spectrum Pharmaceuticals Approval of Evomela (melphalan) for Injection
HENDERSON, Nev., March 15, 2016 --(BUSINESS WIRE)--Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today...

FDA Expands Use of Xalkori (crizotinib) to Treat ROS-1 Positive Non-Small Cell Lung Cancer
March 11, 2016 -- The U.S. Food and Drug Administration today approved Xalkori (crizotinib) to treat people with advanced (metastatic) non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration. Xalkori is the first and only FDA...

FDA Approves Imbruvica (ibrutinib) for the First-Line Treatment of Chronic Lymphocytic Leukemia
NORTH CHICAGO, Ill., March 4, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) approved Imbruvica (ibrutinib) as a first-line treatment for patients with...

FDA Approves Idelvion (coagulation factor IX (recombinant), albumin fusion protein) to Treat Patients with Hemophilia B
March 4, 2016 -- The U.S. Food and Drug Administration today approved Idelvion, Coagulation Factor IX (Recombinant), Albumin Fusion Protein, for use in children and adults with Hemophilia B. Idelvion is the first coagulation factor-albumin fusion...

FDA Approves Odefsey (emtricitabine, rilpivirine and tenofovir alafenamide) for the Treatment of HIV-1 Infection
FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 1, 2016-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or...

FDA Approves Afinitor (everolimus) for Progressive, Nonfunctional Gastrointestinal and Lung Neuroendocrine Tumors (NET)
EAST HANOVER, N.J., Feb. 26, 2016 Novartis today announced that the United States Food and Drug Administration (FDA) approved Afinitor (everolimus) tablets for the treatment of adult patients with progressive, well-differentiated, nonfunctional...

FDA Approves Genentechs Gazyva (obinutuzumab) for Certain People with Previously Treated Follicular Lymphoma
South San Francisco, CA -- February 26, 2016 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Gazyva (obinutuzumab) plus bendamustine chemotherapy...

Allergan Announces FDA Approval of Aczone (dapsone) Gel, 7.5% for Treatment of Acne Vulgaris
DUBLIN, Feb. 25, 2016 /PRNewswire/ -- Allergan plc (NYSE:AGN), a leading global pharmaceutical company, today announced that the Company has received approval from the U.S. Food and Drug Administration (FDA) to market Aczone (dapsone) Gel, 7.5%, a...

Pfizer Announces FDA Approval of Xeljanz XR (tofacitinib citrate), the First and Only Once-Daily Oral JAK Inhibitor Treatment for Rheumatoid Arthritis
February 24, 2016 -- Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Xeljanz XR (tofacitinib citrate) extended-release 11 mg tablets for the once-daily treatment of moderate to severe rheumatoid...

Pfizer Receives Expanded FDA Approval For Ibrance (palbociclib) In HR+, HER2- Metastatic Breast Cancer
Friday, February 19, 2016 -- Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication expanding the use of Ibrance (palbociclib) 125mg capsules, Pfizers metastatic breast cancer...

FDA Approves Briviact (brivaracetam) to Treat Partial Onset Seizures
February 19, 2016 -- The U.S. Food and Drug Administration yesterday approved Briviact (brivaracetam) as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy. Epilepsy is a...

FDA Approves Two Supplemental Indications for Harvoni in Chronic Hepatitis C Patients With Advanced Liver Disease
FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 16, 2016-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved additional indications for Harvoni (ledipasvir/sofosbuvir) for use in chronic...

Arbor Pharmaceuticals Announces FDA Approval of Cetylev
Atlanta, GA, February 9, 2016 -- Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Cetylev (acetylcysteine effervescent tablets for oral solution). Cetylev is an...

Promius Pharma Receives FDA Approval for Sernivo (betamethasone dipropionate) Spray
HYDERABAD, India & PRINCETON, N.J., February 07, 2016 --(BUSINESS WIRE)--Dr. Reddys announced today that its US subsidiary, Promius Pharma, LLC, U.S. (BSE: 500124, NSE: DRREDDY, NYSE: RDY), has received approval for Sernivo (betamethasone...

FDA Approves Expanded Use of Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C
PRINCETON, N.J., February 5, 2016 --(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that Daklinza (daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA)...