Savara resubmits FDA application for potential treatment in rare lung disease patients

The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer

Diamyd Medical accelerates Phase 3 Type 1 diabetes trial following FDA guidance

The interim efficacy readout, involving around 170 participants with 15-month data, remains on track for the end of March 2026

INOVIO’s DNA therapy for rare throat disease gets FDA review

INOVIO remains confident in the therapy’s benefits and intends to meet with the FDA to discuss maintaining eligibility under this pathway

Hansa Biopharma submits FDA application for kidney transplant desensitization treatment

If approved, imlifidase has the potential to transform the kidney transplant landscape by enabling highly sensitized patients to also have access to a potentially life-changing kidney transplant

Zydus Partners with Bioeq for US commercialisation rights for Nufymco

NUFYMCO BLA has been approved by the USFDA

Vanda Pharmaceuticals seeks FDA nod for breakthrough psoriasis drug

Imsidolimab, an IgG4 IL-36 receptor antagonist, works by inhibiting IL-36 receptor signaling, directly addressing the deficiency in the IL-36RA regulator common in GPP patients

Bristol Myers Squibb scores FDA priority review for Opdivo in advanced hodgkin lymphoma

The FDA aims to make a decision by April 8, 2026

Denali clinches $275 million royalty deal to power potential breakthrough Hunter Syndrome therapy

FDA rejects Regeneron’s Eylea HD pre-filled syringe application amid manufacturing setbacks

FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma

The Fast Track Designation was supported by nonclinical data as well as clinical results from the ongoing Phase I/IIa trial evaluating the safety and tolerability