FDA

FDA Grants Orphan Drug Designation to Huntington Disease Treatment

FDA Grants Orphan Drug Designation to Huntington Disease Treatment

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In animal studies, the treatment was associated with improvement in both motor and cognitive function.

FDA to Update Medical Device Approvals Process

FDA to Update Medical Device Approvals Process

The FDA announcement came a day after the release of findings from an investigation into medical device safety worldwide.

FDA Cracks Down on Companies Selling Dietary Supplements Containing Tianeptine

FDA Cracks Down on Companies Selling Dietary Supplements Containing Tianeptine

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While approved in Europe, Asia and Latin America, tianeptine is an unscheduled pharmaceutical agent in the US that has been linked to serious adverse events, including death, when used for recreational purposes.

Promacta Approved as First-Line Treatment for Severe Aplastic Anemia

Promacta Approved as First-Line Treatment for Severe Aplastic Anemia

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The approval was based on data from a single-arm, open-label sequential cohort study in which patients received Promacta in combination with horse antithymocyte globulin (h-ATG) and cyclosporine.

FDA Approves New Treatment for Travelers' Diarrhea

FDA Approves New Treatment for Travelers' Diarrhea

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Aemcolo is a broad spectrum, semi-synthetic, orally-administered, minimally-absorbed antibiotic designed to allow for delayed release to the colon.

FDA Proposes New Restrictions on Sale of Electronic Nicotine Delivery Systems

FDA Proposes New Restrictions on Sale of Electronic Nicotine Delivery Systems

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The announcement comes in the wake of results from the 2018 National Youth Tobacco Survey which showed a 78% increase in current e-cigarette use among high school students from 2017 to 2018.

Keytruda Gets FDA Approval for Hepatocellular Carcinoma

Keytruda Gets FDA Approval for Hepatocellular Carcinoma

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The approval was based on data from the KEYNOTE-224 study, a single-arm trial in patients with HCC who had disease progression on or after sorafenib or were intolerant to sorafenib; had measurable disease; and Child-Pugh class A liver impairment.

Hypertension Combo Pill Recalled Due to Presence of Probable Carcinogen

Hypertension Combo Pill Recalled Due to Presence of Probable Carcinogen

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Losartan Potassium and Hydrochlorothiazide Tablets are approved to treat hypertension, alone or in combination with other antihypertensive drugs.

FDA: Lifted Label Defect May Delay Emergency Treatment With EpiPen

FDA: Lifted Label Defect May Delay Emergency Treatment With EpiPen

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To ensure that the auto-injector can be easily removed from the carrier tube, healthcare providers should inspect the product prior to dispensing.

FDA Clears Patient Controller Platform for Stimwave's Neuromodulation Device

FDA Clears Patient Controller Platform for Stimwave's Neuromodulation Device

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The new software enables patients to fine-tune the power level and modify programs that were pre-programmed by their clinician to control pain.

FDA Committees Vote on Opioid System Modulator for MDD Treatment

FDA Committees Vote on Opioid System Modulator for MDD Treatment

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In the meeting documents, the panel presented a scenario which illustrated their concerns regarding potentially complex drug interactions that may occur in the population for which the drug is intended.

FDA Approves Diagnostic Test to Help Determine Menopausal Status

FDA Approves Diagnostic Test to Help Determine Menopausal Status

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The FDA's marketing approval was supported by data from 690 women (aged 42 to 62 years) who were enrolled in the Study of Women's Health Across the Nation.

Expiration Dates Extended for Certain Lots of Generic Adrenaclick

Expiration Dates Extended for Certain Lots of Generic Adrenaclick

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Epinephrine auto-injectors are indicated for the emergency treatment of allergic reactions (Type 1) including anaphylaxis.

Lynparza Granted Orphan Drug Status for Pancreatic Cancer

Lynparza Granted Orphan Drug Status for Pancreatic Cancer

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Lynparza, a poly (ADP-ribose) polymerase (PARP) inhibitor, is being assessed in the ongoing Phase 3 POLO trial.

FDA Amends Food Additive Regulations to No Longer Allow Use of 7 Substances

FDA Amends Food Additive Regulations to No Longer Allow Use of 7 Substances

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The petition was submitted by a number of non-profit organizations including the Center for Science in the Public Interest and the Breast Cancer Fund.

FDA Panel Votes on Drug/Device Combo to Treat Pain in Medically Supervised Setting

FDA Panel Votes on Drug/Device Combo to Treat Pain in Medically Supervised Setting

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The FDA is not bound by the Committee's recommendation but takes it into consideration when making its decision.

FDA Panel Votes on Prucalopride for Chronic Idiopathic Constipation

FDA Panel Votes on Prucalopride for Chronic Idiopathic Constipation

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The panel's decision was made based on data from from five Phase 3 studies and one Phase 4 trial which evaluated the safety and efficacy of prucalopride in patients with chronic constipation.

Treatment for Alagille Syndrome Granted Orphan Drug Designation

Treatment for Alagille Syndrome Granted Orphan Drug Designation

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Alagille syndrome affects approximately 1 in 70,000 newborns.

Talzenna Approved for Germline BRCA-Mutated, HER2-Negative Breast Cancer

Talzenna Approved for Germline BRCA-Mutated, HER2-Negative Breast Cancer

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Talzenna, a poly (ADP-ribose) polymerase (PARP) inhibitor, was evaluated in EMBRACA, an open-label trial that randomized patients with gBRCAm HER2-negative locally advanced or metastatic breast cancer to receive talazoparib 1mg or physician's choice of chemotherapy.

Liletta Now Approved for Pregnancy Prevention for Up to 5 Years

Liletta Now Approved for Pregnancy Prevention for Up to 5 Years

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The expanded approval was supposed by safety and efficacy data from the Phase 3 ACCESS IUS trial in women receiving Liletta.

FDA Announces Draft Guidance for Consumer OTC Access to Previously Prescription Drugs

FDA Announces Draft Guidance for Consumer OTC Access to Previously Prescription Drugs

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The US Food and Drug Association has issued a draft guidance for helping prescription medications gain approval for nonprescription status.

FDA Issues Safety Communication Regarding Pen Needle Use

FDA Issues Safety Communication Regarding Pen Needle Use

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Standard pen needles have an outer cover and removable inner needle cover, while safety pen needles have an outer cover and a fixed inner needle shield that is not removed before an injection.

Researchers Recommend Reclassification of Psilocybin

Researchers Recommend Reclassification of Psilocybin

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Currently, psilocybin, a serotonin receptor agonist, is classified as a Schedule I agent as it has not been approved by the Food and Drug Administration (FDA) for any therapeutic use.

FDA: Final Guidance on Heparin-Containing Devices, Combo Products

FDA: Final Guidance on Heparin-Containing Devices, Combo Products

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The intent of the document is to help reduce heparin product overdose errors caused by misinterpretation of the drug strength displayed in the labeling.

FDA Finds Another Carcinogen in Certain Valsartan Heart Medications

FDA Finds Another Carcinogen in Certain Valsartan Heart Medications

The US Food and Drug Administration warns that it has found a second impurity in three lots of Torrent Pharmaceuticals' valsartan drug products.

FDA Outlines Plan for New Analgesic Guidance to Combat Opioid Crisis

FDA Outlines Plan for New Analgesic Guidance to Combat Opioid Crisis

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The new plan will break out the current guidance into 4 separate guidances.

Study Finds Clinical Trials for Newer, Breakthrough Therapies Lacking

Study Finds Clinical Trials for Newer, Breakthrough Therapies Lacking

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More than half of the new approvals of Breakthrough Therapy drugs were based on a single pivotal trial.

FDA Seeks to Standardize Regulation of Mobile Medical Apps

FDA Seeks to Standardize Regulation of Mobile Medical Apps

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Appropriate and standardized regulation of mobile medical applications may enable faster adoption and integration of these technology platforms in the health care environment

FDA Taps Social Media to Identify and Assess Emerging Drug Abuse Threats

FDA Taps Social Media to Identify and Assess Emerging Drug Abuse Threats

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The FDA continues to battle the nation's opioid problem even as it looks to detect and prevent the next threat.

FDA Clears Smartphone-Enabled Urinalysis Kit for Home Use

FDA Clears Smartphone-Enabled Urinalysis Kit for Home Use

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The Dip.io kit works in tandem with existing smartphone cameras and a dedicated app.

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