Drug Approvals

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.

Oral Therapy for Suicidal Bipolar Depression Gets Breakthrough Designation

Oral Therapy for Suicidal Bipolar Depression Gets Breakthrough Designation

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NRX-101 combines D-cycloserine (DCS), an N-methyl-D-aspartate (NMDA) receptor antagonist, and lurasidone, a D2/5-HT2a receptor antagonist.

Trump Administration Announces Plan to Cut Drug Prices

Trump Administration Announces Plan to Cut Drug Prices

HHS study shows Medicare pays 80 percent more than other countries for certain prescription drugs

Solutions for Hyperhidrosis: Newly Approved Treatments and Research Update

Solutions for Hyperhidrosis: Newly Approved Treatments and Research Update

Newly approved treatment options for axillary hyperhidrosis give more opportunities for clinicians to provide personalized treatment for patients.

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 (N=1751) in women receiving Liletta. In the trial, Liletta demonstrated >99% efficacy in preventing pregnancy for up to 5 years in a broad patient population.

Xerava Approved for the Treatment of Complicated Intra-Abdominal Infections

Xerava Approved for the Treatment of Complicated Intra-Abdominal Infections

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Eravacycline was well-tolerated in clinical trials and achieved high cure rates in patients with Gram-negative pathogens (including resistant strains).

Cassipa Approved as Maintenance Treatment for Opioid Dependence

Cassipa Approved as Maintenance Treatment for Opioid Dependence

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Cassipa combines buprenorphine, an opioid (partial agonist-antagonist), and naloxone, an opioid antagonist.

FDA Approves Two New Oral Treatments for HIV-1 Infection

FDA Approves Two New Oral Treatments for HIV-1 Infection

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Delstrigo is approved as a complete regimen whereas Pifeltro is to be administered in combination with other antiretrovirals.

Investigational Therapy Gets Fast Track Status for Recurrent Ovarian Cancer

Investigational Therapy Gets Fast Track Status for Recurrent Ovarian Cancer

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A Phase 1 study in healthy volunteers showed a favorable safety profile with no serious adverse events.

First Generic Version of EpiPen Gets FDA Approval

First Generic Version of EpiPen Gets FDA Approval

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Unlike other generic approvals, epinephrine auto-injectors are considered "combination products" because they consist of both a drug and a device, making the approval process more challenging.

FDA to Review Gimoti for Diabetic Gastroparesis in Adult Women

FDA to Review Gimoti for Diabetic Gastroparesis in Adult Women

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The FDA has set a Prescription Drug User Fee Act target date of April 1, 2019.

Once-Monthly Perseris Approved for the Treatment of Schizophrenia

Once-Monthly Perseris Approved for the Treatment of Schizophrenia

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Perseris, an atypical antipsychotic, has an extended-release delivery system that releases sustained levels of risperidone over 1 month.

FDA Approves FreeStyle Libre 14 Day Flash Glucose Monitoring System

FDA Approves FreeStyle Libre 14 Day Flash Glucose Monitoring System

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The new Flash Glucose Monitoring System enables patients to wear the sensor for up to 14 days compared with the existing FreeStyle Libre System that was approved for 10-day wear.

FDA to Review Novel Opioid Analgesic for Chronic Low Back Pain

FDA to Review Novel Opioid Analgesic for Chronic Low Back Pain

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This novel agent has low permeability across the blood-brain barrier, which slows its rate of entry into the brain and reduces dopamine release.

First Marijuana-Based Drug Approved to Treat LGS, Dravet Syndrome

First Marijuana-Based Drug Approved to Treat LGS, Dravet Syndrome

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This marks the first approved drug that contains an active ingredient derived from marijuana as well as the first treatment approved for patients with Dravet syndrome.

Post-Op Pain Treatment Gets Breakthrough Therapy Designation

Post-Op Pain Treatment Gets Breakthrough Therapy Designation

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The Company indicated that they will work towards an New Drug Application submission for the treatment in the second half of 2018.

Novel Antibiotic for <i>C Difficile</i> Infection Gets FDA's QIDP Designation

Novel Antibiotic for C Difficile Infection Gets FDA's QIDP Designation

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ACX-362E is a targeted, narrow spectrum oral antibiotic that blocks the DNA replication process through inhibition of polymerase III, which has been shown to be bactericidal.

FDA Approves Non-Opioid Treatment for Opioid Withdrawal

FDA Approves Non-Opioid Treatment for Opioid Withdrawal

Lucemyra is an oral selective alpha 2-adrenergic receptor agonist

First-of-Its-Kind Migraine Drug Receives FDA Approval

First-of-Its-Kind Migraine Drug Receives FDA Approval

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The efficacy of Aimovig was evaluated as a preventive treatment of episodic or chronic migraine in 3 randomized, double-blind, placebo-controlled studies: 2 studies in patients with episodic migraine (4-14 migraine days per month) and 1 study in patients with chronic migraine (≥15 headache days per month with ≥8 migraine days per month).

FDA Expands Use of MS Drug to Include Children

FDA Expands Use of MS Drug to Include Children

Gilenya is the first multiple sclerosis drug approved for children

Parkinson Drug May Be Linked to Deaths

Parkinson Drug May Be Linked to Deaths

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The FDA advisory committee voted 12-2 in favor of recommending the approval of Nuplazid.

Switching from Branded to Authorized Generic Drugs Linked to Lower Switchback Rate

Switching from Branded to Authorized Generic Drugs Linked to Lower Switchback Rate

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Switching back to branded drugs is more likely in generic drug than authorized generic drugs.

FDA Approves Multi-Cancer Treatment Drug

FDA Approves Multi-Cancer Treatment Drug

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The FDA has approved Rubraca, a poly (ADP-ribose) polymerase inhibitor, to treat patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Fycompa sNDA Submitted for Pediatric Seizure Indications

Fycompa sNDA Submitted for Pediatric Seizure Indications

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The proposed pediatric indications are based on a 2018 Draft Guidance that supports extrapolating efficacy data of approved drugs to treat POS in adults to pediatric patients aged ≥4 years.

NCCN's anticancer drug recommendations beyond FDA approval based on weak evidence

NCCN's anticancer drug recommendations beyond FDA approval based on weak evidence

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Does weak evidence drive the NCCN recommendations of FDA-approved drugs?

FDA OKs new medication for individuals with resistant HIV

FDA OKs new medication for individuals with resistant HIV

A new antiretroviral HIV treatment, Trogarzo (ibalizumab-uiyk), has been approved by the FDA for patients with HIV who have not have success with past HIV medications.

FDA approves new "follow-on" insulin for diabetes

FDA approves new "follow-on" insulin for diabetes

The new FDA approved short-acting insulin drug can be used to treat T1 and T2 diabetes.

FDA approves Tresiba, Ryzodeg for diabetes treatment

FDA approves Tresiba, Ryzodeg for diabetes treatment

The FDA has approved two new treatments, Tresiba and Ryzodeg, for both type 1 and type 2 diabetes.

FDA approves second nonstatin drug to treat patients with high cholesterol

FDA approves second nonstatin drug to treat patients with high cholesterol

The drug is approved for patients who are unable to control their LDL cholesterol with current treatment options.

Oxycontin for 11-year-olds? I'm okay with it

Oxycontin for 11-year-olds? I'm okay with it

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The FDA approval of a pediatric indication for Oxycontin creates a safer situation for terminally ill children.

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