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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.

Trumbull firm’s ultrasound healing device gains traction with athletes

sam Sport is a wearable, bio-regenerative medical device used both to reduce the pain associated with muscle injuries and to accelerate the healing process.

Boehringer Ingelheim and FDA ramp up anti-counterfeit medicine efforts

The pair's “Know Your Source” initiative is the latest step in an international fight against a black market estimated at $200 billion.

FDA issues gluten free labeling standards

U.S. Rep. Nita Lowey announces new federal guidelines for labeling gluten-free foods.

State health officials investigating NJ compounding pharmacy

Med Prep Consulting Inc. is now at the center of an investigation by the Connecticut departments of Consumer Protection and Public Health, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention.

Ardsley biotech company awarded Army contract

Acorda Therapeutics will use an Army contract award for clinical trials of a drug that could treat spinal cord injuries in combat veterans.

Protein Sciences expands into Pearl River

Protein Sciences Corp., a vaccine and biopharmaceutical company, announced last week that it will be establishing manufacturing and developing operations in Pearl River.