PolyPid signs Azurity partnership for D-PLEX100 commercialization in the U.S. and Canada
PolyPid’s Azurity partnership gives D-PLEX100 a U.S. and Canada launch path after Phase 3 SHIELD II surgical site infection data
Pharma & Biotech
Pharma & Biotech
Why Otsuka’s $1.2bn Transcend Therapeutics buyout could reshape PTSD drug development
Find out how Otsuka’s Transcend Therapeutics acquisition could reshape rapid-acting PTSD treatment development.
Pharma & Biotech
Could Spruce Biosciences finally change the Sanfilippo syndrome type B treatment landscape?
Spruce Biosciences’ MPS IIIB data raise a pivotal question: can tralesinidase alfa turn biomarker gains into disease-changing therapy?
Pharma & Biotech
Why Star Therapeutics’ FDA win for VGA039 could reshape the von Willebrand disease treatment race.
Star Therapeutics won dual FDA designations for VGA039 in von Willebrand disease. Read what it could change, and what still needs proving.
Pharma & Biotech
Plixorafenib breakthrough status raises the stakes for FORE Biotherapeutics in BRAF-mutant high-grade glioma
FORE Biotherapeutics won FDA breakthrough status for plixorafenib in high-grade glioma. Read what this changes and what risks still remain.
Pharma & Biotech
No FDA advisory committee for MOLBREEVI: what Savara’s Day 74 Letter means for the August PDUFA review
Savara's molgramostim BLA faces no FDA adcom. Analysis of what the August 2026 PDUFA date means for autoimmune PAP treatment access. Read more.
Pharma & Biotech
Relay Therapeutics secures FDA breakthrough designation for zovegalisib in PIK3CA-mutant HR+/HER2- advanced breast cancer
FDA grants breakthrough therapy designation to Relay Therapeutics’ zovegalisib. Find out what this changes for PI3K-mutant breast cancer treatment.