FDA approval Archives

FDA approval

Accelerated approval for a new mantle cell lymphoma drug

November 22, 2019

The Food and Drug Administration (FDA) has recently granted accelerated approval to BeiGene’s mantle cell lymphoma (MCL) oral therapy, zanubritinib (BRUKINSA). (more…)

Accelerated approval for new sickle cell disease treatment

December 14, 2019

The U.S. Food and Drug Administration (FDA) recently granted accelerated approval to Global Blood Therapeutics’ voxelotor (Oxbryta), a treatment for adults and pediatric patients (12 years and older)…

Emerging treatment for early Alzheimer’s disease

October 30, 2019

Biogen announced that it will pursue the U.S. Food and Drug Administration (FDA)’s regulatory approval process for its drug aducanumab to treat Alzheimer’s disease. (more…)

migraine, nursing journal, healthcare, nursing

FDA approves new treatment for migraine

October 18, 2019

On October 11, 2019, the Food and Drug Administration (FDA) announced a new acute, short-term treatment for patients with migraine. (more…)

FDA Approves New Treatment for Scleroderma

September 24, 2019

In early September 2019, the Food and Drug Administration (FDA) approved a new orphan drug for individuals who face a decline in their pulmonary function due to a…

FDA launches mobile app on antiretrovirals

February 2, 2020

On Jan. 29, the FDA launched an interactive database that will offer a wealth of critical information about antiretrovirals eligible for purchase under the President’s Emergency Plan for…

First FDA approved treatment for thyroid eye disease

January 27, 2020

The U.S. Food and Drug Administration (FDA) recently approved Horizon Therapeutics Ireland DAC’s teprotumumab-trbw (Tepezza) as the first FDA-approved treatment for adults with thyroid eye disease (TED). (more…)

First targeted therapy for rare mutation of gastrointestinal stromal tumors

January 13, 2020

The U.S. Food and Drug Administration (FDA) recently announced the approval of Blueprint Medicines Corporation’s avapritinib (Ayvakit) for the treatment of adult patients with metastatic gastrointestinal stromal tumor…

New FDA guidelines on risks of smokeless tobacco products

October 26, 2019

For the first time ever, the U.S. Food and Drug Administration (FDA) has authorized eight Swedish Match USA, Inc. snus smokeless tobacco products to be marketed through the…

New treatment for acute hepatic porphyria

December 4, 2019

The U.S. Food and Drug Administration (FDA) recently granted approval to Alnylam Pharmaceuticals’ givosiran (Givlaari), a new treatment for adult patients with acute hepatic porphyria (AHP). (more…)

New treatment for advanced epithelioid sarcoma

January 30, 2020

The U.S. Food and Drug Administration (FDA) recently approved Epizyme, Inc’s tazemetostat (TAZVERIK) for the treatment of adult and pediatric patients with metastatic or advanced epithelioid sarcoma (AES).…

New treatment for cystic fibrosis

October 25, 2019

The U.S. Food and Drug Administration has approved a new “breakthrough therapy” for cystic fibrosis (CF) in late October 2019. (more…)

New treatment for multiple myeloma

March 8, 2020

The U.S. Food and Drug Administration (FDA) recently approved Sanofi-Aventis’ Sarclisa (isatuximab-irfc) for the treatment of adult patients with multiple myeloma. Isatuximab-irfc was previously designated its orphan drug…

New treatment for peanut allergy in children

February 4, 2020

The U.S. Food and Drug Administration (FDA) recently approved Aimmune Therapeutics’ Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] for children suffering from peanut allergy. (more…)

Potential new targeted therapy for Duchenne muscular dystrophy

January 3, 2020

The U.S. Food and Drug Administration (FDA) recently granted accelerated approval for Sarepta Therapeutics’ golodirsen (Vyondys 53), an injection for patients with Duchenne muscular dystrophy (DMD) with a…

Potential new treatment for atopic dermatitis

November 1, 2019

Eczema is a common ailment for many people, but a more severe type of eczema not as well-known, atopic dermatitis (AD), may have a new treatment option available.…

Potential new treatment for peanut allergies

November 6, 2019

Aimmune Therapeutics is set to present new data on its AR101 compound, Palforzia, a potential new treatment for peanut allergies, in early November 2019 at the American College…