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Dengvaxia: Philippines FDA revokes CPR, ‘Sanofi has shown complete disregard of FDA rules’

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In a follow-up on the Dengvaxia situation in the Philippines, the Food and Drug Administration (FDA) reports permanently revoking the Certificates of Product Registration (CPR) of dengue vaccine Dengvaxia...

Fascioliasis drug, Egaten receives FDA approval

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Novartis announced this week the approval of Egaten® (triclabendazole) by the US Food and Drug Administration (FDA) for the treatment of fascioliasis in patients six years of age and older. Egaten is...

Newborn herpes: Acyclovir labeling provides drug dosing and use in newborns

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Newborns infected with herpes simplex virus (HSV) can be appropriately treated with acyclovir, a drug typically prescribed to adults for the treatment of HSV infections. Acyclovir’s drug label now includes...

Antibiotics: FDA accepts review regulatory filings for Merck investigational combo drug and ZERBAXA®

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Merck announced this week that the U.S. Food and Drug Administration (FDA) has accepted for review regulatory filings for two antibacterial agents. These filings are: (1) a NDA accepted for Priority Review...

Antifungal drug, TOLSURA™, now available in the US

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Australian company, Mayne Pharma announced this week that their antifungal drug, TOLSURA™ (SUBA®-itraconazole) 65mg capsule, will be launched in the United States. TOLSURA is a new formulation of...

Ebola treatment, mAb114, safe in adults

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The investigational Ebola treatment mAb114 is safe, well-tolerated, and easy to administer, according to findings from an early-stage clinical trial published in The Lancet. Eighteen healthy adults...

Investigational Clostridium difficile infection treatment granted Fast Track designation

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Biopharmaceutical company focused on developing new antibiotics for difficult-to-treat bacterial infections, Acurx Pharmaceuticals announced today that the U.S. Food and Drug Administration has granted...

Ebola drug: UTMB experimental treatment effective in single dose in animals

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There is a new medication that in one dose successfully protected nonhuman primates against a lethal infection of all strains of the deadly Ebola virus. The findings are now available in Cell Host &...

Antibiotic recall: Lupin pulls ceftriaxone; particulate matter found in reconstituted vials

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Lupin Pharmaceuticals, Inc. is voluntarily recalling 5 lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, 1g and...

Fluoroquinolone antibiotics warning: Aortic aneurysm risk in certain patients

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The Food and Drug Administration (FDA) issued a Drug Safety Communication warning health care professionals to avoid prescribing fluoroquinolone antibiotics to patients who have an aortic aneurysm or are...