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Apr 01, 2026
The liposomal doxorubicin market is projected to grow from $1.32 billion in 2025 to $1.77 billion by 2030, while the broader breast cancer drugs market is expected to reach $54.49 billion by 2036. Growth is driven by increasing cancer incidence, adoption of targeted therapies, and advancements in drug delivery systems including liposomal formulations and antibody-drug conjugates.
Apr 01, 2026
The FDA has shifted from regulatory ambiguity to coordinated enforcement against compounded oral semaglutide, culminating in a 2026 announcement of intent to take action against non-approved GLP-1 drugs. Hims & Hers Health's 2024 oral semaglutide offering marked the beginning of a broader regulatory reckoning that saw manufacturer pressure, formal shortage declarations, and warning letters targeting compounding practices.
Apr 01, 2026
Oncolytics Biotech received FDA Fast Track Designation for pelareorep in KRAS-mutant colorectal cancer based on data showing 33% response rate and 27-month median survival. The company is launching a Phase 2 study and recently completed reincorporation from Canada to Nevada. This marks the second Fast Track Designation for pelareorep in gastrointestinal cancers.
Apr 01, 2026
The FDA has approved Eli Lilly's GLP-1 weight loss pill Foundayo, which will compete with Novo Nordisk's Wegovy pill. Foundayo will be available through LillyDirect and pharmacies, with prices ranging from $25 with insurance to $149-$349 for cash payers. The approval sets up a new battle in the oral GLP-1 market between the two pharmaceutical giants.
Apr 01, 2026
Patient-derived organoids demonstrate clinically meaningful predictive value in drug development, with validation studies showing concordance between organoid drug-response profiles and patient outcomes. These models enable earlier go/no-go decisions and more rational clinical trial design, as evidenced by their use in developing FDA Breakthrough Therapy designated candidates.
Apr 01, 2026
The FDA has granted Fast Track designation to Pasithea Therapeutics' PAS-004 for treating NF1-associated plexiform neurofibromas. The designation facilitates expedited development and review for serious conditions with unmet medical needs. Pasithea is currently conducting Phase 1/1b trials of the next-generation MEK inhibitor in patients with these tumors.
Apr 01, 2026
A study of over 600,000 patients reveals GLP-1 drugs may reduce addiction across multiple substances, with 50% fewer substance-related deaths and significant reductions in overdoses and hospitalizations. The drugs work by dampening dopamine signaling in brain reward centers. Researchers are exploring broader applications for these medications beyond diabetes and obesity treatment.
Apr 01, 2026
Express Scripts has added Milestone Pharmaceuticals' CARDAMYST nasal spray to its national formularies, improving access to the first FDA-approved self-administered treatment for PSVT in 30 years. The drug was approved in December 2025 and clinical studies show it converts PSVT episodes twice as likely and three times faster than placebo. The company has also submitted a marketing application to European regulators.
Apr 01, 2026
The FDA has cleared Abbisko Therapeutics' IND application for ABSK061, an oral FGFR2/3 inhibitor for achondroplasia, while BridgeBio reports positive Phase 3 results for its oral infigratinib in the same condition. Both companies are advancing oral therapies targeting FGFR3 overactivity in this genetic growth disorder.
Mar 31, 2026
The FDA has granted Priority Review for lirafugratinib, an FGFR2 inhibitor for second-line cholangiocarcinoma treatment, with a PDUFA date of September 27, 2026. Clinical trial data showed a 46.5% objective response rate and 11.8-month median duration of response. The therapy demonstrated a manageable safety profile with lower rates of common FGFR inhibitor side effects.
Apr 01, 2026
Recursion reported Q4 2025 financial results with $754 million in cash providing runway into early 2028. The company achieved clinical validation of its AI platform with REC-4881 showing meaningful polyp reductions in FAP patients and received its fifth Sanofi milestone payment. Full-year revenue reached $74.7 million while net loss widened to $644.8 million.
Mar 31, 2026
The European Medicines Agency has approved Shield Therapeutics' FeRACCRU® for adolescents aged 12 and older, following FDA approval of ACCRUFeR® for children 10+. The expansion was supported by Phase 3 pediatric trial data showing efficacy and safety in children as young as 1 month.
Mar 31, 2026
The FDA has granted Priority Review to relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies, with a PDUFA target date of September 2026. Phase 2/3 trial data showed a 53% placebo-adjusted reduction in motor seizures and 66.2% increase in seizure-free days. If approved, it would be the first targeted therapy for these rare, fatal childhood conditions.
Mar 31, 2026
Pharmaceutical companies are delaying European drug launches due to uncertainty over U.S. pricing policies under President Trump. New drug launches in EU markets fell 35% following Trump's executive order on international reference pricing. Companies fear lower European prices could undermine their ability to maintain higher prices in the $700 billion U.S. market.
Mar 31, 2026
The FDA has accepted Praxis Precision Medicines' NDA for relutrigine with priority review and set a PDUFA target date of September 27, 2026. The therapy targets SCN2A and SCN8A developmental and epileptic encephalopathies and could become the first approved treatment for these rare conditions. The company has bolstered its cash position to support commercial launch preparations.
Mar 31, 2026
Viridian Therapeutics reported positive Phase 3 results for elegrobart in thyroid eye disease, showing significant proptosis reduction and diplopia resolution. The company plans a BLA submission in Q1 2027 and has another IGF-1R inhibitor, veligrotug, under FDA Priority Review with a June 2026 decision date.
Mar 30, 2026
Tempest Therapeutics reported 2025 financial results showing $7.7 million in cash and highlighted clinical progress including 100% complete response rate in TPST-2003 CAR-T trial and multiple FDA designations for amezalpat in hepatocellular carcinoma. The company completed strategic CAR-T asset acquisition and plans Phase 2b registrational study for its lead program in 2026.
Mar 30, 2026
New research reveals that ultra-marathon running damages red blood cells, making them less flexible and accelerating their breakdown. The study found this damage increases with race distance and could potentially lead to anemia. The findings may also help improve blood storage practices for medical transfusions.
Mar 31, 2026
Clinical trials take 10-15 years and cost $1-2 billion from discovery to approval, progressing through four phases from safety testing to real-world monitoring. These studies face challenges including high costs, regulatory oversight, and participant recruitment while new technologies are transforming trial design. Illinois faces a shortage of Phase I clinical trial facilities despite local companies conducting over 50 such trials annually.
Mar 30, 2026
The National Comprehensive Cancer Network has updated its bladder cancer guidelines to include ImmunityBio's Anktiva plus BCG for BCG-unresponsive papillary-only disease. The Category 2A recommendation expands treatment options beyond the drug's initial FDA approval for carcinoma in situ. ImmunityBio also announced its pivotal trial is adequately powered and European distribution partnerships to expand global access.
