Exebacase Gains Breakthrough Therapy Status for MRSA Bacteremia, Including Right-Sided Endocarditis
Exebacase is a novel, recombinantly-produced lysin (cell wall hydrolase enzyme), that targets the peptidoglycan cell wall.
All articles by Steve Duffy
Investigational Antibiotic Gets Orphan Drug Status for Pulmonary Exacerbations of Cystic Fibrosis
The FDA has granted Orphan Drug designation to ARV-1801 (sodium fusidate; Arrevus) for the treatment of pulmonary exacerbations in patients with cystic fibrosis.
Vaccine to Prevent Ricin Intoxication Gets Fast Track Status
The FDA has granted Fast Track designation to RiVax® for the prevention of ricin intoxication.
Recarbrio Gets Priority Review for Hospital-Acquired, Ventilator-Associated Bacterial Pneumonia
The FDA has accepted for review a sNDA for Recarbrio™, to treat adult patients with hospital-acquired and ventilator-associated bacterial pneumonia.
Influenza Vaccine for Older Adults Granted Fast Track Status
The Food and Drug Administration has granted Fast Track designation to NanoFlu (Novavax) for seasonal influenza vaccination in adults ≥65 years.
Haymarket Medical Education Receives Interprofessional Joint Accreditation for the Healthcare Team
Caroline O. Pardo, Ph.D., General Manager for Haymarket Medical Education, is pleased to announce that HME, based in Paramus, NJ, has been accredited as a provider of interprofessional continuing education by the Accreditation Council for Continuing Medical Education, the Accreditation Council for Pharmacy Education, and the American Nursing Credentialing Center.
Renal Impairment Labeling Updates for Sofosbuvir-Based HCV Therapies
The FDA has approved updated labeling for Epclusa, Harvoni and Vosevi to include updated information regarding treatment of patients with HCV who have severe renal impairment including those with end stage renal disease who are on dialysis.
FDA Clears Test for Detecting HIV Drug-Resistant Mutations
The test may help clinicians tailor HIV therapy for their patients.
Baloxavir Marboxil Approved for Patients at High Risk of Flu-Related Complications
The FDA has approved a supplemental NDA for Xofluza for the treatment of acute, uncomplicated influenza in patients aged 12 years and older.
Emtricitabine and Tenofovir Alafenamide Combination for HIV-1 PrEP Gets FDA Approval
The FDA has approved Descovy for HIV-1 PrEP in at-risk adults and adolescents (≥35kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at-risk from receptive vaginal sex.
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