The recall is due to samples of the product testing positive for Salmonella.
The FDA has granted Fast Track designation to CNTX-4975, a highly potent, ultrapure, synthetic form of trans-capsaicin, for the treatment of pain associated with knee osteoarthritis.
The Food and Drug Administration is requiring that changes be made to the labeling of prescription cough and cold medicines containing codeine and hydrocodone.
The Food and Drug Administration is taking action against 3 companies who market and distribute street drug alternatives that may pose safety concerns.
US WorldMeds announced that the Food and Drug Administration has accepted for Priority Review the New Drug Application for lofexidine to manage the symptoms associated with opioid withdrawal and to facilitate completion of opioid discontinuation treatment.
The Food and Drug Administration's Commissioner Scott Gottlieb, MD, has issued a statement regarding the deadly risks associated with the botanical substance, kratom.
Teva announced the submission of a Biologics License Application to the FDA for fremanezumab for the prevention of migraine.
Drugs that receive accelerated approval status from the FDA are associated with increased safety-related label changes after approval.
The Food and Drug Administration, in partnership with Interpol, has cracked down on over 500 websites that illegally sell potentially dangerous, unapproved medications to US consumers.
The FDA recommended the approval of CTL019 chimeric antigen receptor (CAR) T cell therapy for acute lymphoblastic leukemia (ALL).
The FDA approved Duzallo, a fixed-dose tablet combining lesinurad and allopurinol, for the treatment of uncontrolled gout.
Researchers attempted to quantify the environmental effects of disposing certain drugs by flushing them down the toilet, and found that this approach poses a negligible eco-toxicological risk.
A precautionary recall of Menveo, a meningitis vaccine, was announced by GlaxoSmithKline due to a mechanical intervention.
Boehringer Ingelheim has initiated a clinical study to investigate the interchangeability between an adalimumab biosimilar candidate and Humira.
Sequoia Sciences announced that the FDA has granted Fast Track Designation to its investigational vaccine for recurrent urinary tract infections caused by multi-drug resistant bacteria.
GlaxoSmithKline has made the decision to discontinue manufacturing Ceftin Oral Suspension, a cephalosporin antibacterial drug.
The FDA has accepted for review the Biologics License Application for Aimovig for migraine prophylaxis in patients experiencing more than 4 migraine days per month.
Highlights from the National Academies of Sciences, Engineering, and Medicine report titled "Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use."
The FDA has announced a new policy to expedite reviews of generic drug applications in cases where competition is limited.
Naldemedine, a recently approved agent for opioid-induced constipation, showed good safety and significantly higher responder rates than placebo in a couple of 12-week, international, randomized trials.
The FDA is restricting the use of codeine and tramadol medicines in children.
The FDA released guidance to establish standards for communications about products.
The Food and Drug Administration has accepted for review the New Drug Application for Zilretta for the treatment of patients with osteoarthritis of the knee.
The FDA has issued a final guidance document for the naming of reference biological products and biosimilars.
Dr Katz formulated 10 recommendations for the FDA, 3 of which he detailed during his presentation.
Analysis found roughly 10 percent of cases were filed after 15-day deadline passed.
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- Set of Interventions May Effectively Reduce Opioid Overprescribing
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