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May 05, 2026
Artios added six senior leaders in 2026 as alnodesertib moved toward late-stage development and potential U.S. commercialization. The company is also running a Phase 2 study of ART6043.
May 05, 2026
Cellectar reported 12-month follow-up from the Phase 2b CLOVER WaM trial of iopofosine I 131 in relapsed or refractory Waldenström macroglobulinemia. In 55 patients, ORR was 83.6%, MRR was 61.8% and median duration of response was 17.8 months.
May 05, 2026
The FDA granted Breakthrough Therapy Designation to bezuclastinib plus sunitinib for previously treated GIST. The PEAK trial showed median progression-free survival of 16.5 months versus 9.2 months for sunitinib alone.
May 05, 2026
Operation Stork Speed aims to update U.S. infant formula standards. An FDA report due this spring is expected to review contaminants, ingredients and new safety protocols.
May 05, 2026
FDA approval of daratumumab for high-risk smoldering multiple myeloma marks a shift from observation to early intervention. In a Phase II trial in earlier-stage disease, the overall response rate was 54% and the primary endpoint was not met.
May 05, 2026
CVRx announced first-patient enrollment in the BENEFIT-HF trial, a 2,500-patient heart failure study across about 150 U.S. and German centers. The trial will evaluate all-cause mortality and heart failure decompensation events through 2032.
May 05, 2026
Topline phase 3 VIKTORIA-1 results showed gedatolisib combinations improved progression-free survival versus alpelisib plus fulvestrant in PIK3CA-mutant HR-positive/HER2-negative advanced breast cancer. Celcuity plans a supplemental FDA filing based on the data.
May 05, 2026
The global antibody drug conjugate market is calculated at USD 14.76 billion in 2026 and is expected to reach USD 32.66 billion by 2035. North America held a 53% share in 2025, while Asia Pacific is projected to grow fastest.
May 05, 2026
BioMarin reported first-quarter 2026 revenue of $766 million and raised full-year guidance to $3.825 billion-$3.925 billion. The company highlighted FDA approval of PALYNZIQ for adolescents and upcoming Phase 3 readouts for BMN 401 and VOXZOGO.
May 05, 2026
Vertex completed the rolling BLA submission for povetacicept in IgA nephropathy after positive Phase 3 RAINIER interim data. The company plans to use a Priority Review Voucher to accelerate FDA review.
May 05, 2026
AbbVie raised 2026 revenue and EPS guidance after first-quarter results beat estimates, with Skyrizi and Rinvoq driving growth. Humira erosion continued as neuroscience, oncology and pipeline assets supported the outlook.
May 04, 2026
GLP-1 drugs used for type 2 diabetes and obesity are seeing rising demand for weight loss as safety concerns also draw attention. A 2025 WHO guideline said long-term safety data remains limited.
May 04, 2026
The FDA said one pivotal trial plus confirmatory evidence will become the default standard for approval of most new drugs. The shift could extend beyond rare diseases to common conditions affecting millions.
May 04, 2026
Krystal Biotech said IOLITE enrollment for KB803 is complete and it remains on track for KB803 and KB801 registrational data readouts in 2026. The company also reported FDA platform technology designations for KB407 and KB111 and continued VYJUVEK expansion.
May 04, 2026
Cynata raised $1.5 million through a placement at $0.25 a share ahead of Phase 3 osteoarthritis and Phase 2 aGvHD trial readouts due in May and June 2026. Its aGvHD study has completed the 100-day primary evaluation period for all 65 participants.
May 03, 2026
Ruxolitinib remains the standard frontline therapy for intermediate-2 and high-risk myelofibrosis, with phase 3 and real-world data showing spleen and symptom benefits. Cytopenias, transfusion needs and resistance after 2 to 3 years continue to drive interest in new combinations.
May 03, 2026
Arcutis is in focus after new Phase 3 extension data for Zoryve cream 0.05% in young children with atopic dermatitis and ahead of its Feb. 25 Q4 results. Investors are also watching recent FDA actions and pipeline updates for additional pediatric and dermatology indications.
May 03, 2026
C-peptide is described as a key biomarker for beta cell function in type 1 diabetes and a potential surrogate endpoint for drug approval. Current trial endpoints remain difficult for disease-modifying therapies.
May 02, 2026
Vermont insurers and employers are scaling back GLP-1 coverage as costs rise, leaving some patients without access. The drugs remain in high demand as studies point to benefits beyond weight loss.
May 02, 2026
Pfizer reported new clinical and regulatory milestones across oncology, obesity and hemophilia, including BREAKWATER Phase 3 data and Priority Review for HYMPAVZI. The company also cited MagnetisMM-5 results and FDA priority review for PADCEV.
