Mar 28, 2026
Enveric Biosciences reports positive preclinical results for lead candidate EB-003 showing efficacy in depression and PTSD models. The company has completed pre-IND studies and received FDA feedback for streamlined IND submission, with plans for Phase 1 trials in 2026. New BRET assay data demonstrates EB-003's engagement of therapeutic signaling pathways while independent research supports separation from hallucinogenic effects.
Mar 28, 2026
CRISPR Therapeutics reported a Q4 2025 loss of $1.37 per share, missing estimates, with revenues of $0.9 million falling short of expectations. The company's partner Vertex recorded $54 million in Casgevy sales for the quarter, with regulatory submissions for pediatric label expansion planned for early 2026.
Mar 28, 2026
Sacituzumab tirumotecan demonstrated a median overall survival of 20.0 months versus 13.5 months with docetaxel in pretreated EGFR-mutated NSCLC patients. The phase 2 OptiTROP-Lung03 study showed a hazard ratio of 0.63 for overall survival benefit with the TROP2-directed antibody-drug conjugate.
Mar 28, 2026
Class action lawsuits allege false statements about clinical trial results and regulatory prospects at Atara Biotherapeutics, Ultragenyx, Mereo BioPharma, and Vistagen Therapeutics. The complaints cite failed Phase 3 studies for setrusumab in Osteogenesis Imperfecta and fasedienol for social anxiety disorder, along with manufacturing issues affecting Atara's tabelecleucel application. Investors have deadlines ranging from April to May 2026 to seek lead plaintiff status.
Mar 28, 2026
The FDA will now allow drug approval based on a single pivotal trial instead of two, a policy change confirmed in a New England Journal of Medicine paper. The new guidance maintains requirements for confirmatory evidence and focuses on trial design quality, aiming to reduce development costs and speed drugs to market. FDA officials argue this approach may actually improve standards by concentrating scrutiny on a single well-designed study.
Mar 27, 2026
The FDA rejected accelerated approval for Disc Medicine's bitopertin for erythropoietic protoporphyria, citing insufficient evidence that biomarker reductions translate to clinical benefit. The agency wants to see results from the ongoing Phase 3 APOLLO trial before considering traditional approval, pushing any decision to at least mid-2027. Disc Medicine plans to address FDA concerns with APOLLO data expected in Q4 2026.
Mar 26, 2026
The European Union has approved a higher 7.2 mg maintenance dose for Wegovy (semaglutide) for chronic weight management. Clinical trial data shows mean weight loss of 20-21% with the 7.2 mg dose compared to 17-18% with the standard 2.4 mg dose. The approval provides clinicians with an on-label option for patients with inadequate response to standard dosing.
Mar 26, 2026
Quoin Pharmaceuticals has secured Orphan Drug Designations for QRX003 in the U.S. and Europe for Netherton Syndrome, while advancing regulatory pathways in Japan and Saudi Arabia. The company reported clinical progress including expansion of pediatric studies and potential for a Priority Review Voucher worth up to $200 million.
Mar 27, 2026
Despite guidelines recommending broad molecular profiling for precision oncology, biomarker testing faces significant implementation barriers including insurance coverage limitations, lengthy turnaround times, and tissue adequacy issues. Studies show most patients lack biomarker results at initial consultation, with up to 43% having insufficient tissue for genotyping in NSCLC cases.
Mar 26, 2026
The ProSense Cryoablation System achieved an 83.9% recurrence-free rate in kidney cancer patients after 4 years in the ICESECRET trial. The system treats small renal masses up to 5 cm and is approved in multiple global markets. Detailed results will be presented at the European Conference on Interventional Oncology in April 2026.
Mar 26, 2026
Eli Lilly has acquired rights to CSL's IL-6 inhibitor clazakizumab in a $100 million deal, expanding its cardiometabolic pipeline. The monoclonal antibody targets chronic inflammation, particularly in cardiovascular conditions. This move follows Lilly's successful obesity and diabetes drugs that drove $65.1 billion in 2025 revenue.
Mar 27, 2026
Inovio Pharmaceuticals faces a class action lawsuit alleging false statements about manufacturing deficiencies affecting its INO-3107 drug candidate. The lawsuit claims the company exaggerated its ability to file a BLA by mid-2024 and misled investors about accelerated FDA review prospects. Following FDA acceptance for standard rather than accelerated review, Inovio's stock dropped 24.45%.
Mar 26, 2026
Cardinal Health has recalled certain lots of Webcol Large Alcohol Prep Pads due to potential contamination with Paenibacillus phoenicis bacteria. The affected pads were distributed between September 2025 and February 2026 and pose infection risks, particularly for immunocompromised individuals. The FDA is aware of the voluntary recall.
Mar 26, 2026
The FDA has approved Agilent's PD-L1 IHC 22C3 pharmDx as a companion diagnostic for identifying esophageal cancer patients eligible for Merck's KEYTRUDA immunotherapy. This marks the eighth FDA-approved indication for this diagnostic test with KEYTRUDA. The test helps identify patients whose tumors express PD-L1 for potential treatment with the anti-PD-1 therapy.
Mar 26, 2026
Kodiak Sciences' experimental drug Zenkuda achieved 62.5% response rate in diabetic retinopathy trial with 85% reduction in sight-threatening complications. The company plans to accelerate FDA submission while preparing for wet AMD study readout in Q3 2026. Shares surged 68.6% following the positive late-stage results.
Mar 27, 2026
The FDA has approved Optune Pax, a Tumor Treating Fields device, for use with chemotherapy in locally advanced pancreatic cancer. The approval is based on phase 3 trial data showing improved overall survival and pain progression outcomes. This marks the first new treatment approach for this patient population in approximately 30 years.
Mar 26, 2026
Avidity Biosciences announced promising Phase 1/2 trial results for its myotonic dystrophy type 1 drug delpacibart etedesiran, showing 40% reduction in DMPK mRNA and functional improvements. The therapy has received multiple regulatory designations and is now in Phase 3 testing with data expected in late 2026. The company's stock has surged 128% over the past year despite reporting a net loss of approximately $550 million.
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.
