Tag: Food and Drug Administration

Helius Medical Technologies, a Newtown-based medical device company, has begun exploring “strategic alternatives,” including a reverse merger and licensing deal, to enhance stockholder value…

Malvern-based Annovis Bio plans to focus on patients who have the early form of Alzheimer’s disease in the future development of its experimental…

The Food and Drug Administration has selected Bala Cynwyd-based Larimar Therapeutics’ lead drug candidate for its new program inspired by the Operation Warp Speed…

Yardley-based Optinose got the green light from the Food and Drug Administration for their flagship nasal spray Xhance, writes John George for the Philadelphia…

Yardley-based Optinose, known for its drug-device product Xhance, is at a pivotal moment as it awaits a decision from the Food and Drug…

Newcomer drug manufacturer KVK Tech Inc. and its occupancy of the dormant Lockheed site were considered a Newtown boon in 2015. But it didn’t…

NRx Pharmaceuticals out of Radnor has once again filed an application with the Food and Drug Administration for emergency use of its experimental COVID-19…

Following weeks of stagnation, vaccinations are again rising in Pennsylvania. An extended — and unfortunate — lift in COVID-19 cases, hospitalizations, and deaths in the past…

The U.S. Attorney’s Office filed charges against KVK-Tech, Inc., a generic drug manufacturer in Newtown, reports John George for the Philadelphia Business…

The Harmony Transcatheter Pulmonary Valve (TPV)

On March 21, U.S. Food and Drug Administration (FDA) gave thumbs up to a nonsurgical heart valve that…

Helius Medical Technology — a medical device company in Newtown — has received marketing clearance from the Food and Drug Administration, clearing its flagship product, writes John…