United Therapeutics gets June 2027 FDA date for once-daily oral ralinepag
FDA has accepted United Therapeutics’ ralinepag NDA with a June 24, 2027 PDUFA date after ADVANCE OUTCOMES showed a 55% reduction in first clinical worsening events.
Pharma & Biotech
Pharma & Biotech
Hanmi lands up to $2.3bn Genentech deal as non-incretin obesity drug HM17321 reaches its first human test
Genentech has licensed HM17321 outside South Korea for $190 million upfront and up to about $2.3 billion in total potential payments, betting on a UCN2 mechanism designed to reduce fat while preserving lean mass.
Pharma & Biotech
RenovoRx pancreatic cancer data show targeted delivery changes gemcitabine exposure in TIGeR-PaC
RenovoRx reports 51% targeted gemcitabine extraction with TAMP in pancreatic cancer. See what the data mean ahead of TIGeR-PaC results.
Pharma & Biotech
Japan approves pediatric ORLADEYO as BioCryst Pharmaceuticals expands hereditary angioedema reach
Japan expands ORLADEYO to children aged 2 to under 12 as BioCryst Pharmaceuticals builds its global HAE franchise. See what comes next.
Pharma & Biotech
Ziihera moves into first-line HER2-positive cancer treatment after pivotal Phase 3 results
FDA expands Ziihera into first-line HER2-positive gastroesophageal cancer. See how the approval could reshape treatment and Zymeworks growth.
Pharma & Biotech
Why Johnson & Johnson’s IMAAVY FDA approval could reshape wAIHA treatment
Johnson & Johnson has secured FDA approval for IMAAVY in warm autoimmune hemolytic anemia, giving eligible patients aged 12 and older the first treatment specifically approved in the United States for wAIHA.
Pharma & Biotech
VarmX begins 800-patient Phase 3 trial of VMX-C001 for urgent surgery in Factor Xa inhibitor patients
The global EquilibriX-S trial will compare VMX-C001 with usual pharmacological care in approximately 800 patients taking Factor Xa inhibitors who require urgent high-bleeding-risk procedures.
Pharma & Biotech
Abcuro raises $66m to retry ulviprubart after Phase 2/3 IBM trial misses
Abcuro will use a $66 million Series D to start another potentially registrational study after MUSCLE failed overall but showed a prespecified signal in patients with less severe disease.
Pharma & Biotech
Japan clears IMCIVREE for acquired hypothalamic obesity as Rhythm Pharmaceuticals expands global reach
Japan approves IMCIVREE for acquired hypothalamic obesity, expanding Rhythm Pharmaceuticals’ global franchise. See what the approval means for growth.
Pharma & Biotech
ERAS-0015 gets FDA Fast Track status after 57% response signal in pancreatic cancer
ERAS-0015 wins FDA Fast Track status after a 57% early response signal in KRAS pancreatic cancer as Erasca prepares three registration-focused trials.