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Aug 14, 2026
Keros Therapeutics plans a phase II DMD trial of rinvatercept in Q1 2026 and regulatory talks for ALS in H2 2026. Cash stands at $383 million with runway into H1 2028.
Jul 21, 2026
The FDA has approved Tregzi, a donor-derived T-cell immunotherapy, to reduce the risk of chronic graft-versus-host disease following stem cell transplant in adults with high-risk blood cancers. In a pivotal trial, 78% of recipients were alive and free of severe chronic GVHD at one year versus 38.4% with standard transplant.
Jun 22, 2026
Research estimates 300 million people worldwide live with rare diseases, yet only 5% of conditions have approved treatments. Patients face diagnostic delays of 4.7 to 8 years, with emerging AI and machine learning tools showing promise in accelerating diagnosis and drug development.
Jun 21, 2026
Cantargia reported full year 2025 financial results with net sales of SEK 316.7 million and cash of SEK 281.8 million. The company secured a SEK 124 million financing package to advance clinical development of nadunolimab, including a phase Ib study combining it with a RAS inhibitor in pancreatic cancer.
Jun 15, 2026
The FDA has cleared an IND for Amphista's novel BRD9 degrader AMX-883 for AML, approved Lantheus' new prostate cancer imaging agent Pylarify TruVu, and accepted Biofrontera's sNDA for Ameluz PDT in superficial basal cell carcinoma. These regulatory milestones span hematologic and solid tumor areas, addressing significant unmet medical needs.
May 19, 2026
The FDA granted Orphan Drug Designation to Cullinan Therapeutics’ CLN-049 for relapsed/refractory AML. CLN-049 is in Phase 1 studies and had already received Fast Track designation.
Feb 24, 2026
Faron Pharmaceuticals announces acceptance of bexmarilimab Phase I/II data for poster presentation at BSH 2026, while launching a new Phase II BEAM-X study evaluating the drug in AML patients post-stem cell transplantation.
Feb 23, 2026
Higher consumption of ultraprocessed food after cancer diagnosis is associated with increased rates of all-cause and cancer mortality, regardless of overall diet quality, according to a study of 802 cancer survivors.
Feb 19, 2026
Faron Pharmaceuticals announces Phase II BEAM-X trial evaluating bexmarilimab plus azacitidine in MRD-positive AML patients after stem cell transplantation. The Nordic AML Group-led trial will enroll 24 patients with first results expected 12-15 months after enrollment begins in Q3 2026.
May 01, 2025
The FDA approved 46 novel drugs in 2025, down from 50 in 2024. Small molecules accounted for 31 approvals (67%), with oncology leading at nine approvals. Large molecules contributed 15 approvals (33%), spanning ADCs, bispecifics, and subcutaneous delivery innovations.
Jan 16, 2026
The FDA has approved Filkri (filgrastim-laha), a biosimilar to Neupogen, for cancer patients at risk of infection due to chemotherapy and other indications. The approval marks Accord BioPharma's sixth biosimilar product.
