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Tag: approvals

FDA approves first drug for treatment of peanut allergy for children

February 1, 2020 Blogger Leave a comment

FDA approves first drug for treatment of peanut allergy for children — Read on s2027422842.t.en25.com/e/es This is a huge achievement…

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Posted in: Health Technology Filed under: approvals, FDA, pdufa, technology

FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer

January 24, 2020 Blogger Leave a comment

FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer — Read on s2027422842.t.en25.com/e/es

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Posted in: Health Technology Filed under: approvals, pdufa

First Generic Drug Approvals | FDA

January 11, 2020 Blogger Leave a comment

Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides…

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Posted in: Uncategorized Filed under: approvals, FDA, gdufa

FDA grants accelerated approval to first targeted treatment for rare Duchenne Muscular Dystrophy (DMD) mutation – Drug Information Update

December 13, 2019 Blogger Leave a comment

FDA grants accelerated approval to first targeted treatment for rare Duchenne Muscular Dystrophy (DMD) mutation – Drug Information Update —…

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Posted in: Health Technology Filed under: approvals, FDA, pdufa

FDA Updates List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

Blogger Leave a comment

FDA Updates List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic — Read on s2027422842.t.en25.com/e/es

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Posted in: Uncategorized Filed under: approvals, FDA, gdufa

Drug Trials Snapshots BRUKINSA | FDA

December 1, 2019 Blogger Leave a comment

Drug Trials Snapshots — Read on www.fda.gov/drugs/resources-information-approved-drugs/drug-trials-snapshots-brukinsa More inhibitors for oncology.

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Posted in: Health Technology Filed under: approvals, FDA, pdufa

FDA approves new breakthrough therapy for cystic fibrosis | FDA

October 21, 2019 Blogger Leave a comment

FDA approves breakthrough therapy Trikafta for patients 12 and older with cystic fibrosis who have at least one F508del mutation…

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Posted in: Health Technology Filed under: approvals, FDA, fixed dose combination, pdufa, technology

FDA approves new treatment for patients with migraine | FDA

October 11, 2019 Blogger Leave a comment

The U.S. Food and Drug Administration today approved Reyvow (lasmiditan) tablets for the acute (active but short-term) treatment of migraine…

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Posted in: Uncategorized Filed under: approvals, pdufa

Drug Trials Snapshots: IBSRELA | FDA

September 27, 2019 Blogger Leave a comment

IBSRELA is a treatment for Irritable bowel syndrome with constipation The disease has two variants, with diarrhea and with constipation…

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Posted in: Health Technology Filed under: approvals, pdufa

DAURISMO for Acute Myeloid Leukemia

September 22, 2019 Blogger Leave a comment

On November 2018, the FDA approved Pfizer’s glasdegib (Daurismo) for the treatment of newly diagnosed acute myeloid leukemia (AML) in…

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Posted in: Health Technology Filed under: approvals, FDA, pdufa

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