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Mar 26, 2026
Orphan drug sales are projected to reach $400 billion by 2032, accounting for over 21% of prescription drug sales. Recent policy changes expanded IRA exemptions for multi-indication orphan drugs and reauthorized pediatric review vouchers. Johnson & Johnson's Darzalex leads orphan drug sales with $31 billion projected revenue.
Mar 26, 2026
Amneal Pharmaceuticals recalls magnesium sulfate after a pouch intended for pregnant women was found containing tranexamic acid instead. The medication mix-up could cause serious adverse events including seizures and blood clotting if administered incorrectly.
Mar 25, 2026
Clinical trials show psychedelic substances like psilocybin, LSD and MDMA combined with therapy can effectively treat depression, anxiety and addiction. Several substances are in Phase III trials, with esketamine already approved for treatment-resistant depression. Research suggests these treatments may work with fewer doses than traditional medications.
Mar 26, 2026
The FDA approved milsaperidone for bipolar I disorder and schizophrenia, while COMP360 psilocybin met its primary endpoint in a second phase 3 trial for treatment-resistant depression. Phase 2a data showed intravenous DMT (SPL026) significantly reduced depressive symptoms in major depressive disorder patients.
Mar 26, 2026
The FDA has approved Lifyorli (relacorilant) plus nab-paclitaxel for platinum-resistant ovarian cancer based on trial data showing improved survival. Separately, the agency granted Breakthrough Therapy designation to Lilly's sofetabart mipitecan for the same condition, expediting development of the antibody-drug conjugate.
Mar 26, 2026
Precigen reported $3.4 million in first commercial sales of PAPZIMEOS in Q4 2025 following FDA approval for recurrent respiratory papillomatosis. The drug has received standard of care endorsement from physician experts and now covers approximately 90% of insured U.S. lives. The company has $100.4 million in cash and is pursuing European regulatory approval.
Mar 25, 2026
Diamyd Medical anticipates March 2026 interim results from its Phase 3 diabetes trial that could support a BLA pathway. Capricor Therapeutics awaits an August 2026 FDA decision on its Duchenne muscular dystrophy treatment BLA. Bicara Therapeutics prepares for Phase 3 study initiation of its oncology candidate toward future BLA submission.
Mar 25, 2026
Iterion Therapeutics has dosed the first patient in a phase 1/2 trial of its Wnt/β-catenin inhibitor tegavivint for metastatic colorectal cancer. The expansion builds on promising monotherapy activity observed in advanced hepatocellular carcinoma, targeting a pathway activated in over 90% of colorectal cancer patients.
Mar 24, 2026
The FDA has eased biosimilar approval procedures as these therapies have generated $56 billion in savings since 2015. New guidance eliminates comparative efficacy studies, potentially saving manufacturers $100 million per product and cutting development time by 50%. Despite growth to 23% of the biologics market, a "biosimilar void" threatens $232 billion in missed savings over the next decade.
Mar 25, 2026
The myelofibrosis therapeutic pipeline now includes over 40 candidates from more than 35 companies, with recent developments including Orphan Drug Designation for CK0804 and multiple Phase III trial initiations. Key clinical milestones include completed enrollment in Karyopharm's SENTRY trial and upcoming Phase I data from Incyte's combination therapy studies.
Mar 25, 2026
ImmunityBio reported a fivefold revenue increase to $38.29 million, driven by a 750% surge in unit sales of its cancer drug Anktiva. The company is expanding internationally through partnerships in the Middle East and preparing additional FDA submissions for Anktiva's broader use.
Mar 25, 2026
The FDA approved subcutaneous amivantamab for EGFR-mutated NSCLC in December 2025 based on phase 3 PALOMA-3 trial data showing noninferior efficacy with reduced infusion reactions and 5-minute administration time. The formulation decreases infusion-related reactions from 66% to 13% and improves patient convenience and quality of life. Recent MARIPOSA trial updates show amivantamab plus lazertinib extends median overall survival by at least 12 months versus osimertinib monotherapy.
Mar 24, 2026
The cell therapy manufacturing market is projected to reach $14.01 billion by 2035, with CAR-T therapies dominating at 65% market share. Recent FDA approvals for new CAR-T indications and Japanese regulatory acceleration highlight growing clinical adoption, while research advances include new anti-aging protein platforms and CRISPR-based treatments.
Mar 24, 2026
Ocular Therapeutix's experimental drug Axpaxli showed superior vision maintenance compared to Regeneron's Eylea in a late-stage wet AMD trial. Meanwhile, Ocugen reported 12-month data showing its gene therapy OCU410 reduced geographic atrophy lesions by 31%, though less than earlier interim results. Both companies are advancing toward regulatory submissions and further clinical development.
Mar 24, 2026
A meta-analysis of 20,806 cancer patients shows women have significantly improved survival rates but higher risk of severe treatment side effects compared to men. Separate research indicates nutrition counseling could support fertility in female cancer survivors, though implementation faces barriers. Specialized cancer nurses play a crucial role in providing stability and support throughout cancer treatment.
Mar 24, 2026
Researchers have discovered that vitamin B3 (niacin) can effectively target microRNA-93, a key genetic driver of fatty liver disease. The study shows niacin reduces miR-93 levels and increases SIRT1 activity, restoring normal fat-processing pathways in the liver. This finding suggests a widely available vitamin could become a new treatment for metabolic-associated fatty liver disease affecting 30% of people globally.
Mar 24, 2026
Egetis Therapeutics completed its rolling New Drug Application for Emcitate® (tiratricol) for MCT8 deficiency in the USA on January 29, 2026. The drug received European Commission approval in February 2025 and launched in Germany in May 2025. The company also provided updates on Japanese regulatory progress and the status of its Aladote® candidate for paracetamol overdose.
Mar 24, 2026
A clinical trial combining laser interstitial thermal therapy with pembrolizumab immunotherapy showed nearly half of recurrent high-grade astrocytoma patients alive at 18 months, far exceeding typical survival. Separate research reveals steroids make glioblastoma cells vulnerable to dietary interventions targeting their altered metabolism.
Mar 24, 2026
HHS Secretary Robert F. Kennedy Jr. announces major reorganization centralizing department operations under CMS leadership, while Duke University telehealth program shows 66% reduction in repeat ER visits for older adults who fall.
Mar 24, 2026
Legal scholars argue FDA-required drug labels should not serve as evidence in patent infringement cases against generic manufacturers. The Supreme Court will hear a case involving this "infringement by label" theory, which could clarify that regulatory compliance alone doesn't prove patent violation. This approach threatens affordable generic drug access by creating liability for companies following FDA rules.
