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FDA approval
The Food and Drug Administration (FDA) has recently granted accelerated approval to BeiGene’s mantle cell lymphoma (MCL) oral therapy, zanubritinib (BRUKINSA). (more…)
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)…
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…)
On October 11, 2019, the Food and Drug Administration (FDA) announced a new acute, short-term treatment for patients with migraine. (more…)
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…
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…
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…)
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…
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…
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…)
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).…
The U.S. Food and Drug Administration has approved a new “breakthrough therapy” for cystic fibrosis (CF) in late October 2019. (more…)
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…
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…)
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…
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.…
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…
Accelerated approval for a new mantle cell lymphoma drug
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
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…
Emerging treatment for early Alzheimer’s disease
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.…
FDA approves new treatment for migraine
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
In early September 2019, the Food and Drug Administration (FDA) approved a new orphan drug for individuals who face a decline in their pulmonary…
FDA launches mobile app on antiretrovirals
On Jan. 29, the FDA launched an interactive database that will offer a wealth of critical information about antiretrovirals eligible for purchase under the…
First FDA approved treatment for thyroid eye disease
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…
First targeted therapy for rare mutation of gastrointestinal stromal tumors
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…
New FDA guidelines on risks of smokeless tobacco products
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…
New treatment for acute hepatic porphyria
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
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…
New treatment for cystic fibrosis
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
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…
New treatment for peanut allergy in children
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
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…
Potential new treatment for atopic dermatitis
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…
Potential new treatment for peanut allergies
Aimmune Therapeutics is set to present new data on its AR101 compound, Palforzia, a potential new treatment for peanut allergies, in early November 2019…