Why Mirum Pharmaceuticals and Incyte’s zilurgisertib data could reset expectations in FOP treatment
Read how Mirum and Incyte’s zilurgisertib Phase 2 data could reshape FOP treatment, FDA review risk and rare disease strategy.
Pharma & Biotech
Pharma & Biotech
Johnson & Johnson’s IMAAVY data sharpen the FcRn strategy beyond myasthenia gravis
Find out how Johnson & Johnson’s IMAAVY data could reshape treatment strategy in warm autoimmune hemolytic anemia.
Pharma & Biotech
Can Sanofi’s venglustat priority review change the treatment outlook for type 3 Gaucher disease?
Sanofi’s venglustat could target neurological type 3 Gaucher disease. The FDA review now tests whether rare disease care can shift.
Pharma & Biotech
Roche’s giredestrant FDA review raises the stakes in adjuvant breast cancer treatment
Find out how Roche’s giredestrant FDA priority review could reshape endocrine therapy in early breast cancer.
Pharma & Biotech
Nuvalent’s ALK inhibitor gets Priority Review as lung cancer treatment sequencing evolves
Nuvalent’s neladalkib has FDA Priority Review in ALK-positive lung cancer. Find out why resistance and brain metastases drive the story.
Pharma & Biotech
Takeda and Protagonist near FDA decision on novel PV therapy rusfertide
FDA grants Priority Review to rusfertide for polycythemia vera. Discover what this means for treatment standards and market dynamics.
Pharma & Biotech
Why Beren Therapeutics’ adrabetadex NDA could redefine approval standards in ultra-rare pediatric disease
FDA acceptance of adrabetadex puts disease modification for infantile-onset NPC under review. See what this decision could change for rare disease approvals.
Pharma & Biotech
Can nivolumab plus AVD become the new frontline treatment in classical Hodgkin lymphoma?
FDA fast-tracks review of Opdivo plus AVD for first-line Hodgkin lymphoma. Find out what this immunotherapy combo could change for patients and providers.