Tag: US Food and Drug Administration

September 18, 2019

Cannabis Industry Has “Good Growing Up Summer,” Expert Says

In one expert's estimation, the state of the market has been “symptomatic of a general risk-off appetite in equities” rather...
September 18, 2019

LexaGene Tackling Antibody Resistance with Genetic Analyzer

The company's device has the capabilities to identify pathogens and antibiotic and antimicrobial resistance in as little as an hour.
September 18, 2019

Apollo Endosurgery Gets FDA Clearance for Polypropylene Suture-Anchor Assembly

Apollo Endosurgery (NASDAQ:APEN) has announced it has received 510(k) clearance from the US Food and Drug Administration for its polypropylene...
September 18, 2019

NewLink Genetics Receives FDA Acceptance for Partnered Biologics License Application

NewLink Genetics (NASDAQ:NLNK) has announced that the US Food and Drug Administration has accepted Merck’s (NYSE:MRK)’s Biologics License Application and...
September 16, 2019

Lundbeck to Buy Alder BioPharma in US$2 Billion Deal

Lundbeck will add Alder BioPharma's potential blockbuster migraine treatment, eptinezumab, to its pipeline ahead of patent expirations.
September 16, 2019

Wave Life Sciences Gets Fast Track Designation from FDA

The designation from the FDA has been granted for the company's treatment suvodirsen to treat Duchenne muscular dystrophy.
September 16, 2019

Bellerophon Gets Orphan Drug Designation for Nitric Oxide

The designation has been given by the US Food and Drug Administration to treat patients with idiopathic pulmonary fibrosis.