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Regeneron gets FDA approval for antibody cocktail to fight Covid-19

Tarrytown-based Regeneron has received an emergency use authorization from the U.S. Food and Drug Administration allowing use of its REGEN-COV2 antibody cocktail for the...

FDA authorizes new Covid-19 treatment

The U.S. Food and Drug Administration late Thursday afternoon issued an emergency use authorization to Eli Lilly and Co. to allow use of its...

Shelton’s NanoViricides moves forward with studies of possible Covid treatment

The company intends to perform certain core safety pharmacology studies to ensure safety of the drug candidate at Calvert Labs.

Cannabidiol products store opens in Mount Kisco

It’s not over-the-counter marijuana products that are being sold in a new store in Mount Kisco, although some people may think that’s the case. The...

Regeneron’s Ebola treatment granted FDA approval

Inmazeb is a mixture of three monoclonal antibodies and was designed to treat Zaire ebolavirus. It is the first FDA-approved treatment for Ebola virus infection in adult and pediatric patients.

Regeneron receives $450M federal contract for its potential coronavirus cocktail

Regeneron Pharmaceuticals has received a $450 million contract from the federal government to manufacture and supply REGN-COV2, its investigational treatment of COVID-19. The double antibody...

Westport’s BioSig gets FDA approval to move forward with potential COVID-19...

The trial will occur in hospitalized patients who have confirmed infection with SARS-CoV-2 and require supplemental oxygen.

Seeking a cure: Regeneron and NYMC in COVID-19 study

When a complex process that normally takes seven to nine months is accomplished in only eight days, you can be reasonably certain that something...

Rockland’s Chartwell Pharma says FDA delays cost it $1M

“It is incomprehensible,” the complaint states, that Woodfield “would have so little regard for Chartwell, as its customer, and … efforts at bringing the product to market.”

FDA fast-tracks Intensity Therapeutics’ breast cancer treatment

“Finding improved therapies for this disease is a critical unmet medical need,” said Lewis H. Bender, president and CEO of Intensity Therapeutics.

FDA clearance for Westport-based Lumendi’s surgical device

The product is a sterile, single-use, disposable, monopolar electrosurgical device for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures.

CT shellfish industry, going strong, hopes for EU breakthrough

The FDA has begun the process of restoring U.S. shellfish producers’ access to European markets.

Boehringer Ingelheim gets FDA approval for chronic inflammatory diseases drug

Among the diseases that Cyltezo is meant to treat are moderate to severe active rheumatoid arthritis, psoriatic arthritis, adult Crohn’s disease and ulcerative colitis.

FDA approves Regeneron drug Kevzara for rheumatoid arthritis

The new human antibody drug will be used to treat a chronic inflammatory disease that affects about 1.3 million Americans.

Fujifilm Medical Systems receives FDA approval for mammography software

Among other features, the technology affords radiologists 3D views, rather than the traditional 2D views, during mammographies.