News and Events
Monthly News Roundup - January 2018Opdivo Gains New Adjuvant Use in Melanoma
Adjuvant therapy can reduce the risk of cancer recurrence follow surgery that removes the tumor and lymph nodes. Bristol-Myers Squibb’s Opdivo (nivolumab) is now the first PD-1 inhibitor approved as...FDA, FTC Warn Companies for Selling Illegal, Unapproved Opioid Cessation Products Using Deceptive ClaimsJanuary 24, 2018 -- The U.S. Food and Drug Administration and the Federal Trade Commission today posted joint warning letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims...Monthly News Roundup - December 2017Luxturna 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 UlcersToday, 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 CancerDecember 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 DrugsToday, 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 UseToday 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 DrugsDecember 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 2017FDA 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 WithdrawalNovember 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 CancerNovember 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 2017Yescarta 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 2017FDA 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 ReactionsSeptember 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 CalibrationSeptember 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 OnlineSeptember 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 StatesJERUSALEM--(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.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 2017Kymriah 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 infectionAugust 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 SupplementsAugust 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 2017FDA 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 DeviceJuly 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 ERDUBLIN, 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 ChemotherapyJuly 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 2017New 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 LymphomasJune 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 BacklogJune 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 AccessJune 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 DrugsJune 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 AbuseJune 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)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 2017Actemra: 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 ADHDMay 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 TestsMay 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 BabiesMay 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 2017Takeda 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 PatientsApril 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 ConditionsApril 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 JrMarch 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...