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FDA Grants Priority Review for Gilead's Bictegravir Plus Lenacapavir HIV Treatment Combination
NewsHIV TreatmentApr 29, 2026

FDA Grants Priority Review for Gilead's Bictegravir Plus Lenacapavir HIV Treatment Combination

Gilead Sciences receives FDA priority review for novel once-daily HIV treatment combining bictegravir and lenacapavir, potentially the smallest single-tablet regimen.

James Chen, PharmD
Emergent BioSolutions Partners with Substipharm for $34.5M Japanese Encephalitis Vaccine Manufacturing Deal
NewsApr 29, 2026

Emergent BioSolutions Partners with Substipharm for $34.5M Japanese Encephalitis Vaccine Manufacturing Deal

Emergent BioSolutions announces $34.5M partnership with Substipharm Biologics to manufacture IMOJEV Japanese encephalitis vaccine for U.S. government distribution.

James Chen, PharmD
Novartis Coartem Baby Receives WHO Prequalification as First Malaria Treatment for Newborns
NewsApr 25, 2026

Novartis Coartem Baby Receives WHO Prequalification as First Malaria Treatment for Newborns

WHO prequalifies Novartis Coartem Baby, the first malaria treatment for newborns and young infants, enabling global procurement and access.

Dr. Sarah Mitchell
FDA Approves Merck's IDVYNSO: First Non-INSTI, Tenofovir-Free Two-Drug HIV Treatment
NewsHIV TreatmentApr 22, 2026

FDA Approves Merck's IDVYNSO: First Non-INSTI, Tenofovir-Free Two-Drug HIV Treatment

FDA approves Merck's IDVYNSO (doravirine/islatravir), the first non-INSTI, tenofovir-free two-drug HIV regimen showing non-inferior efficacy to BIKTARVY.

James Chen, PharmD
Aicuris Receives FDA Priority Review for Pritelivir, Novel Herpes Treatment for Immunocompromised Patients
NewsAntiviral - Herpes Simplex Virus InfectionsApr 17, 2026

Aicuris Receives FDA Priority Review for Pritelivir, Novel Herpes Treatment for Immunocompromised Patients

FDA grants Priority Review for Aicuris' pritelivir NDA, targeting resistant herpes infections in immunocompromised patients with Q4 2026 PDUFA date.

Dr. Sarah Mitchell
Elion Therapeutics Launches Phase 2 Trial for Turletricin (EL219) in Invasive Mold Infections
NewsApr 16, 2026

Elion Therapeutics Launches Phase 2 Trial for Turletricin (EL219) in Invasive Mold Infections

Elion Therapeutics initiates Phase 2 clinical trial for turletricin (EL219) targeting invasive mold infections, with FDA Fast Track and QIDP designations.

Dr. Sarah Mitchell