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…
FDA approval
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…
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…
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.…
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…
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…
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…
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…
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…
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…
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…
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.…
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…
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…
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…
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…
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,…
