PRIMAXIN is indicated for the treatment of the following infections in adults and children 1 year of age and above (see sections 4.4 and 5.1): • complicated intra-abdominal infections • severe pneumonia including hospital and ventilator-associated pneumonia • intra- and post-partum infections • complicated urinary tract infections • complicated skin and soft-tissue infections PRIMAXIN may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Merck Inc. announced that the FDA has accepted for review regulatory filings for Priority Review for the combination of MK...
A Phase III, randomised, double-blind, active comparator-controlled clinical trial to estimate the efficacy and safety of imipenem/cilastatin/relebactam versus colistimethate sodium...
The FDA has approved Noxafil (posaconazole) injection (18 mg/ mL), from Merck, a new formulation of the Fungal Infection treatment...
Genentech, a member of the Roche Group announced late-breaking data from the Phase III OCARINA II study.
Zai Lab Limited announced that China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous (SC) injection, 1000mg (5.6ml)/vial) for the treatment of adult patients with generalized myasthenia gravis (gMG)
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has approved Uptravi (selexipag) injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients with WHO functional class (FC) II–III, who are temporarily unable to take oral therapy.
On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Agilus, intended for the treatment of malignant hyperthermia in combination with adequate support measures.The applicant for this medicinal product is Norgine B.V.