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Headline news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.



 



Monthly News Roundup - December 2017

Sun, 31 Dec 2017 22:12:26 GMT

Luxturna Gene Therapy OK’d for Rare Form of Vision Loss A historic approval, Luxturna (voretigene neparvovec-rzyl) from Spark Therapeutics is the first directly administered gene therapy that targets a disease caused by specific gene...



FDA Permits Marketing of Device to Treat Diabetic Foot Ulcers

Thu, 28 Dec 2017 06:12:01 GMT

Today, the Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers. “Diabetes is the leading cause of lower limb amputations,” said Binita Ashar, M.D.,...



FDA Clears Stereotactic Radiotherapy System for Use in Treating Breast Cancer

Fri, 22 Dec 2017 05:12:49 GMT

December 22, 2017 -- Today, the U.S. Food and Drug Administration cleared a new noninvasive stereotactic radiotherapy system intended for use in treating cancer in breast tissue. “With today’s clearance, patients will have access to a treatment...



FDA Proposes New, Risk-Based Enforcement Priorities to Protect Consumers from Potentially Harmful, Unproven Homeopathic Drugs

Mon, 18 Dec 2017 20:12:16 GMT

Today, the Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s...



FDA Launches New Tool for Sharing Information That Allows Doctors to Better Manage Antibiotic Use

Wed, 13 Dec 2017 19:12:21 GMT

Today the Food and Drug Administration is announcing a new approach to get critical updates regarding antibiotics and antifungal drugs to health care professionals as part of an overall effort to combat antimicrobial resistance. The agency created a...



FDA Warns Companies for Promoting Alternatives to Street Drugs

Tue, 12 Dec 2017 19:12:58 GMT

December 12, 2017 -- The U.S. Food and Drug Administration today posted a warning letter to the marketers and distributors of Legal Lean Syrup, a drink, and Coco Loko, a “snortable” chocolate powder, for selling unapproved new drugs and...



Monthly News Roundup - November 2017

Thu, 30 Nov 2017 22:11:55 GMT

FDA Approves Juluca, a Novel 2-Drug Regimen for HIV-1 Infection In November, the U.S. Food and Drug Administration (FDA) approved ViiV Healthcare’s Juluca (dolutegravir and rilpivirine), a single-tablet, two-drug regimen of dolutegravir...



FDA Grants Marketing Authorization of the First Device for Use in Helping to Reduce the Symptoms of Opioid Withdrawal

Wed, 15 Nov 2017 23:11:33 GMT

November 15, 2017 -- Today, the U.S. Food and Drug Administration granted a new indication to an electric stimulation device for use in helping to reduce the symptoms of opioid withdrawal. “Given the scope of the epidemic of opioid addiction, we...



FDA Warns Companies Marketing Unproven Products, Derived From Marijuana, that Claim to Treat or Cure Cancer

Wed, 01 Nov 2017 20:11:52 GMT

November 1, 2017 -- As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency today issued warning letters to four companies illegally selling products online that claim to prevent,...



Monthly News Roundup - October 2017

Tue, 31 Oct 2017 22:10:00 GMT

Yescarta CAR T-Cell Therapy Approved for Lymphoma Novel chimeric antigen receptor T cell (CAR T) therapy allows patients with certain blood cancers -- but limited treatment options -- to achieve remission. The U.S. Food and Drug Administration...



Monthly News Roundup - September 2017

Sat, 30 Sep 2017 21:09:12 GMT

FDA Approves Lilly’s Verzenio: Targeted Breast Cancer Treatment Lilly’s Verzenio (abemaciclib), a CDK 4/6 inhibitor breast cancer treatment, has been FDA-approved. Verzenio is used in 2 patient populations: either with fulvestrant (Faslodex)...



FDA Improves Access to Reports of Adverse Drug Reactions

Thu, 28 Sep 2017 05:10:05 GMT

September 28, 2017 -- The U.S. Food and Drug Administration today launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System...



FDA Approves First Continuous Glucose Monitoring System for Adults Not Requiring Blood Sample Calibration

Wed, 27 Sep 2017 05:10:15 GMT

September 27, 2017 -- The U.S. Food and Drug Administration today approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions...



FDA Conducts Major Global Operation to Protect Consumers From Potentially Dangerous Prescription Drugs Sold Online

Mon, 25 Sep 2017 20:09:58 GMT

September 25, 2017 -- The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved...



Teva Announces Reintroduction of Generic Depo-Provera in the United States

Mon, 25 Sep 2017 01:09:52 GMT

JERUSALEM--(BUSINESS WIRE)--Sep. 25, 2017-- Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) today announced the reintroduction of the generic equivalent to Depo-Provera1 Contraceptive Injection (medroxyprogesterone acetate injectable suspension,...



Criminal and Civil Actions Filed Against Aegerion Pharmaceuticals Inc.

Fri, 22 Sep 2017 20:09:39 GMT

September 22, 2017 -- Today, Aegerion Pharmaceuticals Inc. agreed to plead guilty in the United States District Court for the District of Massachusetts to two misdemeanor counts of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act)...



Monthly News Roundup - August 2017

Thu, 31 Aug 2017 23:08:10 GMT

Kymriah from Novartis Approved as First U.S. CAR-T Cell Therapy History was made this month as the U.S. Food and Drug Administration (FDA) approved the first U.S. cell-based gene therapy known collectively as chimeric antigen receptor (CAR)...



FDA provides new tools for the development and proper evaluation of tests for detecting Zika virus infection

Thu, 17 Aug 2017 21:08:20 GMT

August 17, 2017 -- As an additional measure in the fight against Zika virus, today the U.S. Food and Drug Administration announced that it has made available a panel of human plasma samples to aid in the regulatory evaluation of serological tests to...



FDA Warns of Potential Contamination in Multiple Brands of Drugs, Dietary Supplements

Fri, 11 Aug 2017 21:08:20 GMT

August 11, 2017 -- The U.S. Food and Drug Administration is advising consumers and health care professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby...



Monthly News Roundup - July 2017

Mon, 31 Jul 2017 04:07:10 GMT

FDA Approves Gilead’s Vosevi for Six Hepatitis C Genotypes The U.S. Food and Drug Administration (FDA) has approved Gilead’s Vosevi (sofosbuvir, velpatasvir and voxilaprevir) for retreatment of adults with chronic hepatitis C virus (HCV) of...



FDA Clears First Neonatal Magnetic Resonance Imaging Device

Thu, 20 Jul 2017 22:07:07 GMT

July 20, 2017 -- Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU). “Although we can use traditional MRI...



Endo Provides Update On Opana ER

Thu, 06 Jul 2017 03:07:27 GMT

DUBLIN, July 6, 2017 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER (oxymorphone hydrochloride extended release) when used as intended, and notes...



FDA Clears Expanded Use of Cooling Cap to Reduce Hair Loss During Chemotherapy

Mon, 03 Jul 2017 06:07:35 GMT

July 3, 2017 -- Today, the U.S. Food and Drug Administration cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss (alopecia) during chemotherapy. This is the first cooling cap cleared by the agency for use in...



Monthly News Roundup - June 2017

Fri, 30 Jun 2017 03:06:43 GMT

New Fluoroquinolone Baxdela Approved for Certain Skin Infections Roughly 3 million patients are hospitalized each year in the U.S. with acute bacterial skin and skin structure infections (ABSSSIs), some of which may be difficult-to-treat and...



FDA Allows Marketing of Test to Aid in the Detection of Certain Leukemias and Lymphomas

Thu, 29 Jun 2017 06:07:16 GMT

June 29, 2017 -- The U.S. Food and Drug Administration today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas,...



FDA Unveils Plan to Eliminate Orphan Designation Backlog

Thu, 29 Jun 2017 05:07:24 GMT

June 29, 2017 -- Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm...



FDA Tackles Drug Competition to Improve Patient Access

Tue, 27 Jun 2017 04:07:11 GMT

June 27, 2017 -- Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent,...



Sonar Products Ordered to Cease Operations, Stratus Pharmaceuticals Ordered to Cease Distributing Unapproved Drugs

Thu, 15 Jun 2017 04:07:56 GMT

June 15, 2017 -- Today, U.S. District Judge Kathleen M. Williams for the Southern District of Florida entered a consent decree of permanent injunction between the United States and Stratus Pharmaceuticals Inc. of Miami, Florida, Sonar Products Inc....



FDA Requests Removal of Opana ER for Risks Related to Abuse

Thu, 08 Jun 2017 21:06:27 GMT

June 8, 2017 -- Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is...



FDA Approves First Generic Truvada for HIV Infection and Pre-Exposure Prophylaxis (PrEP)

Thu, 08 Jun 2017 04:06:33 GMT

June 8, 2017 - The U.S. Food and Drug Administration has approved the first generic version of Truvada for the treatment of HIV-1, in combination with other antiretroviral agents, and for pre-exposure prophylaxis (PrEP) in combination with safer sex...



Monthly News Roundup - May 2017

Tue, 30 May 2017 22:05:17 GMT

Actemra: First Drug Approved to Treat Giant Cell Arteritis Actemra (tocilizumab) from Hoffman La Roche has gained a new indication as the first drug approved to treat adults with giant cell arteritis, a specific type of vasculitis. Vasculitis is...



FDA Approves First Generic Strattera for the Treatment of ADHD

Tue, 30 May 2017 11:05:39 GMT

May 30, 2017 -- The U.S. Food and Drug Administration today approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients. Apotex Inc., Teva Pharmaceuticals...



FDA Warns Americans About Risk of Inaccurate Results from Certain Lead Tests

Wed, 17 May 2017 17:05:13 GMT

May 17, 2017 -- The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in...



FDA Authorizes Use of New Device to Treat Esophageal Birth Defect in Babies

Fri, 12 May 2017 13:05:09 GMT

May 12, 2017 -- The U.S. Food and Drug Administration today authorized use of the Flourish Pediatric Esophageal Atresia Anastomosis, a first-of-its-kind medical device to treat infants up to one year old for a birth defect that causes a gap in their...



Monthly News Roundup - April 2017

Sun, 30 Apr 2017 02:04:34 GMT

Takeda Announces FDA Accelerated Approval of Alunbrig The US Food and Drug Administration (FDA) has approved once-daily oral Alunbrig (brigatinib) for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small...



FDA Approves Two Hepatitis C Drugs - Sovaldi and Harvoni - for Pediatric Patients

Fri, 07 Apr 2017 11:05:01 GMT

April 7, 2017 -- The U.S. Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were...



FDA Allows Marketing of First Direct-to-Consumer Tests that Provide Genetic Risk Information for Certain Conditions

Thu, 06 Apr 2017 22:04:39 GMT

April 6, 2017 -- The U.S. Food and Drug Administration today allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA...



FDA Alerts Consumers of Nationwide Voluntary Recall of EpiPen and EpiPen Jr

Fri, 31 Mar 2017 23:03:40 GMT

March 31, 2017 -- The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency...



Monthly News Roundup - March 2017

Fri, 31 Mar 2017 03:03:33 GMT

Ocrevus Approved for Novel Use Among Multiple Sclerosis Treatments The much anticipated multiple sclerosis (MS) treatment Ocrevus (ocrelizumab) was given the green light from the FDA this month. Ocrevus is a humanized monoclonal antibody designed...



Monthly News Roundup - February 2017

Tue, 28 Feb 2017 00:22:32 GMT

FDA Approves Once-Daily Qtern Tablets for Adults with Type 2 Diabetes The U.S. Food and Drug Administration (FDA) has cleared AstraZeneca’s Qtern (dapagliflozin and saxagliptin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl...