TUESDAY, Nov. 27, 2018 — The U.S. Food and Drug Administration is warning men that “Rhino” products promising better sex may pose serious health risks. Since 2007, the FDA has identified more than 25 products marketed with variations of the name Rhino that contained hidden drug ingredients, the agency reported Tuesday. The FDA has received […]Continue Reading ...
Treatment for Postpartum Depression Sage Therapeutics Receives Notification of PDUFA Extension for Zulresso (brexanolone) Injection CAMBRIDGE, Mass.–(BUSINESS WIRE)–Nov. 20, 2018– Sage Therapeutics, Inc. (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug […]Continue Reading ...
MONDAY, Nov. 19, 2018 — The U.S. Food and Drug Administration on Friday expanded approval for the use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with specific types of peripheral T-cell lymphoma (PTCL). The FDA stated in a press release that this approval is the first for treatment of newly […]Continue Reading ...
NOVATO, Calif., Nov. 14, 2018 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, today announced that it has completed a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) and plans to submit a New Drug Application […]Continue Reading ...
(HealthDay)—Rare but serious genital infections, as well as one death, have been reported in some patients taking a certain class of type 2 diabetes medicine, the U.S. Food and Drug Administration says. As a result, the FDA has ordered a new warning about this risk to be added to the prescribing information and patient medication […]Continue Reading ...
The U.S. Food and Drug Administration today expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval […]Continue Reading ...
Today, the U.S. Food and Drug Administration announced that an emergency use authorization (EUA) has been issued for a rapid, single-use test for the detection of Ebola virus (Zaire ebolavirus). This is the second Ebola rapid antigen fingerstick test available under EUA, but the first that uses a portable battery-operated reader, which can help provide […]Continue Reading ...
Treatment for Major Depressive Disorder Alkermes Reports on Outcome of FDA Advisory Committee Meeting on ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder DUBLIN, Nov. 1, 2018 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS) today announced that the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the […]Continue Reading ...
FDA Approves Truxima (rituximab-abbs), a Biosimilar to Rituxan for Non-Hodgkin’s Lymphoma November 28, 2018 — The U.S. Food and Drug Administration today approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with […]Continue Reading ...
November 21, 2018 Audience: Consumer, Health Professional, Pharmacy Investigation ongoing – This page to be updated as more information is available FDA alerts patients and health care professionals to Mylan’s recall of valsartan products due to NDEA Update [11/21/2018] FDA is alerting patients and health care professionals to Mylan Pharmaceuticals’ voluntary recall of 15 lots […]Continue Reading ...
selinexor Treatment for Multiple Myeloma Karyopharm’s Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma NEWTON, Mass., Nov. 07, 2018 (GLOBE NEWSWIRE) — Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast […]Continue Reading ...
The University of Texas MD Anderson Cancer Center applauds new actions announced today by the U.S. Food and Drug Administration (FDA) to limit the sale of most flavored electronic cigarettes (e-cigarettes) to age-restricted locations and require age-verification for online sales to lower the use of these products in children. In addition, the FDA plans to […]Continue Reading ...
The U.S. Food and Drug Administration today announced that, on behalf of the agency, the U.S. Marshals Service has conducted a mass seizure of FDA-regulated products that were being held under insanitary conditions in which they were exposed to widespread rodent, insect and live animal infestation. The seizure occurred Nov. 7 and 8 at J […]Continue Reading ...
Treatment for Pain Trevena Receives Complete Response Letter for Oliceridine from FDA November 2, 2018 — Trevena, Inc. (NASDAQ: TRVN) today announced the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for oliceridine. “While we are disappointed with FDA’s decision, we […]Continue Reading ...
Home News New Drugs FDA Approves Yupelri FDA Approves Yupelri (revefenacin) for Chronic Obstructive Pulmonary Disease (COPD) November 09, 2018 — Today, the U.S. Food and Drug Administration (FDA) approved Yupelri (revefenacin) Inhalation Solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Revefenacin is a long-acting muscarinic antagonist (LAMA), which is […]Continue Reading ...
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- Are caries linked to political regime?
- Leader in Diabetes Clinical Trials Wins Naomi Berrie Award
- Scientists discover cellular mechanism that triggers pneumonia in humans
- Increasing mental health problems related to drug use in over 55’s
- High-intensity interval exercise could help combat cognitive dysfunction in obese people
- Annual flu shot can save lives of heart failure patients
- Researchers compare health outcomes for VA and non-VA hospitals
- Recommendations Developed for Psoriatic Arthritis Treatment
- Genetic analysis links obesity with diabetes, coronary artery disease
- Study shows that having genetic information can affect how the body responds
- UNAIDS Report: 9 Million Are Likely HIV Positive And Don't Know It
- Lund University researchers succeed in obtaining dendritic cells by direct reprogramming
- Breast tumors recruit bone marrow cells to boost their growth, study reveals
- Updated breast cancer screening guideline highlights importance of shared decision-making
- EHR-related stress associated with physician burnout
- AHA: 12-Year-Old Heart Defect Survivor Inspires NFL Player’s Foundation
- Breast cancer patients who take heart drug with trastuzumab have less heart damage
- Providing aid to those humans – and animals – affected by the California fires