FDA Approvals

Doptelet Approved for Liver Disease Patients Slated for a Medical Procedure

MONDAY, May 21, 2018 -- Doptelet (avatrombopag) has been approved by the U.S. Food and Drug Administration to treat adults with chronic liver disease who are slated to have a medical or dental procedure.

People with ongoing liver disease often have low blood platelet count, which raises their risk for dangerous bleeding during a medical procedure, the agency said Monday in a news release.

Read more

Aimovig Approved to Prevent Migraines

FRIDAY, May 18, 2018 -- Aimovig (erenumab-aooe) has been approved by the U.S. Food and Drug Administration to prevent migraine headaches in adults.

Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule involved in migraine attacks, the agency said in a news release.

Read more

Non-Opioid Treatment Approved for Opioid Withdrawal

THURSDAY, May 17, 2018 -- Lucemyra (lofexidine hydrochloride) has been approved by the U.S. Food and Drug Administration to treat symptoms of opioid withdrawal.

Withdrawal from an opioid painkiller can trigger symptoms including anxiety, agitation, sleep problems, muscle aches, sweating, nausea, diarrhea and drug craving. To prevent such symptoms, doctors typically recommend slow withdrawal from the drug, the FDA said.

Read more

'BioSimilar' Drug Approved to Treat Certain Types of Anemia

TUESDAY, May 15, 2018 -- Retacrit (epoetin alfa-epbx) has been approved by the U.S. Food and Drug Administration as the first "biosimilar" to the anemia drugs Epogen and Procrit.

A biosimilar, derived from a living organism, has been proven to be "highly similar" to a product that's already been approved by the FDA. It's also been shown to have no "clinically meaningful differences" in its safety, purity and potency than the prior approved drugs, the agency explained Tuesday in a news release.

Read more

Use of MS Drug Expanded to Include Children

MONDAY, May 14, 2018 -- The U.S. Food and Drug Administration has expanded its approval of the multiple sclerosis drug Gilenya (fingolimod) to include children aged 10 and older.

It's the first multiple sclerosis drug approved for children, the agency said in a news release. The drug was approved in 2010 to treat adults with relapsing MS.

Read more

New Device Cleared for Gastrointestinal Bleeding

MONDAY, May 7, 2018 -- The U.S. Food and Drug Administration has approved the new Hemospray device to help control bleeding of the gastrointestinal tract.

Bleeding in the stomach, intestines, colon or rectum may be caused by factors such as ulcers, malformed blood vessels, diverticulosis, cancer or inflammatory bowel disease, the FDA explained in a news release Monday.

Read more

Drug Duo Approved for Aggressive Thyroid Cancer

FRIDAY, May 4, 2018 -- Two anti-cancer drugs administered together have been approved by the U.S. Food and Drug Administration to treat an inherited form of thyroid cancer.

Tafinlar (dabrafenib) and Mekinist (trametinib) combined have been approved to treat anaplastic thyroid cancer caused by an abnormal BRAF V600E gene, the agency said Friday in a news release.

Read more

First Auto-Darken Contact Lenses Approved

TUESDAY, April 10, 2018 -- The U.S. Food and Drug Administration has approved the first contact lenses that automatically darken in bright light, the agency said Tuesday in a news release.

The technology, used for years in eyeglasses, stems from an additive that's added to the lenses, which then react to the sun's ultraviolet rays. The Acuvue Oasys lenses return to their normal tint when the user moves to normal or darker lighting.

Read more

Blincyto Approval Expanded for Specific Leukemia

THURSDAY, March 29, 2018 -- The U.S. Food and Drug Administration says it has expanded approval for Blincyto (blinatumomab) to include adults and children with B-cell precursor acute lymphoblastic leukemia who are in remission but who still have minimal residual disease (MRD).

MRD describes the presence of cancer cells in the body, but below levels that can be seen in a microscope, the agency said Thursday in a news release. This condition raises a person's chances that the cancer will come back.

Read more

Adcetris Approval Expanded to Include Later-Stage Hodgkin Lymphoma

TUESDAY, March 20, 2018 -- U.S. Food and Drug Administration approval of Adcetris (brentuximab vedotin) has been expanded to include adults with untreated stage III or IV classical Hodgkin lymphoma, the agency said Tuesday in a news release.

The drug was first approved to treat Hodgkin lymphoma in 2011 and has been granted a number of additional approvals.

Read more

Jump to Page :