Seralutinib is an investigational treatment for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
The Autoridade Nacional Reguladora de Medicamentos de Moçambique (ANARME) has achieved Maturity Level 3 (ML3) for regulating medicines and imported vaccines under WHO’s global classification of national regulatory authorities.
The test is now being evaluated for use in Sub-Saharan Africa, where researchers hope it could become the first validated rapid diagnostic test for iron deficiency.
Over the past five years, the collaboration has supported more than 1,300 WellSpan patients across 12 cancer subspecialties through physician consultations, multidisciplinary tumour conferences and access to Johns Hopkins subspecialists.
The company’s focus on both non-potent and high-potency APIs reflects the range of projects handled at the site, from conventional small-molecule development to programs requiring additional containment and specialized handling.
As part of the agreement, Charles River will use technologies such as next-generation sequencing (NGS) to support chemistry, manufacturing and controls (CMC) activities associated with the vaccine programme.
Jhpiego will align its reproductive, maternal and newborn health programmes with the EWENE agenda, initially focusing on 18 priority counties identified by the Government.
The company said India’s Central Drugs Standard Control Organisation (CDSCO) approved the intravenous (IV) formulation, while Taiwan’s Food and Drug Administration (TFDA) approved both Hunterase IV and Hunterase ICV.
Community advocacy contributed to an Indonesian Ministry of Health regulation that allows young people under 18 to be accompanied not only by parents but also by community members and outreach workers when accessing HIV testing.
The technology, DoseMonitor®, connects with the hospital’s imaging equipment to automatically capture data on the amount of radiation used during procedures.