HIV Prevention: Dr Reddy’s Receives US FDA Tentative Approval for Generic Lenacapavir
The long-acting injectable lenacapavir is intended for HIV pre-exposure prophylaxis (PrEP), with initial supplies expected by the end of 2026.
The long-acting injectable lenacapavir is intended for HIV pre-exposure prophylaxis (PrEP), with initial supplies expected by the end of 2026.
Under the agreement, AbbVie will receive exclusive worldwide rights to develop and commercialise Nxera’s EP4 agonist for inflammatory bowel disease.
The directive marks an important regulatory development for the pharmaceutical industry, bringing greater focus on quality assurance, manufacturing practices and compliance across the supply chain.
The launch follows a series of recent regulatory approvals secured by Lupin in the US.
Lonza will acquire the business for a mid-triple-digit million-euro amount. The transaction is expected to close in mid-2027, subject to customary regulatory approvals and other closing conditions.
Researchers identified a likely pathogenic variant in a foetus with nonimmune hydrops fetalis and skeletal abnormalities using whole-exome sequencing, highlighting the diagnostic value of genomic testing in complex prenatal cases.
Under the agreement, Rockwell Medical will acquire Vantive’s hemodialysis concentrates, monitors, water treatment systems, related consumables and technical services business, as well as its manufacturing facility in Italy.
Philips Oxygenate 5 delivers continuous oxygen flow of 0.5–5 L/min and features quieter operation, digital flow monitoring and user-replaceable filters.
Policymakers, industry leaders and biopharma startups discuss regulatory reforms, funding and shared infrastructure to accelerate India’s bioeconomy growth.
The Health Ministry proposes adding additional Inland Container Depots (ICDs), a Special Economic Zone (SEZ), and an international airport to the list of authorised import locations for drugs and medical devices and cosmetics.