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Agropharma Laboratories of Salinas, Puerto Rico, has received a three-observation Form 483 citing issues with laboratory controls, cleanliness of the facility and quality control. Read More
An FDA investigator observed that Belport, a drugmaker in Camarillo, Calif., doing business as Gingi-Pak, didn’t conduct microbiological testing of the water used to manufacture its drug products, among other quality lapses noted during a Nov. 8 to 12, 2021, inspection of its facility. Read More
Despite the fact that many states have lifted their mask mandates and the last surge of a COVID-19 variant of concern peaked several weeks ago, we are nowhere near public health officials announcing the end of the public health emergency, according to epidemiologists who track COVID-19. Read More
AbbVie’s Qulipta (atogepant), already approved for prevention of episodic migraine, has released new phase 3 data that also support its preventive effect for chronic migraine. Read More
Armed with positive phase 3 data, Venatorx Pharmaceuticals will ask regulators to approve its investigational combination antibiotic, cefepime-taniborbactam, as a treatment for complicated urinary tract infections (cUTI) in adults. Read More
“The evidence shows antibiotics are not needed by most children and young people with middle ear infections,” said Paul Chrisp, director of NICE’s Center for Guidelines. Read More
Grassley introduced proposed legislation last year that would require the FTC to report to Congress on possibly anticompetitive prescription drug-pricing practices. Read More