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Apr 11, 2026
A FAERS database analysis identified 13 FDA-approved systemic medications with disproportionately high uveitis reporting signals among 7,301 events from 2003 to 2024. The strongest signals were for cidofovir and rifabutin, and the findings were described as hypothesis-generating rather than causal.
Apr 10, 2026
BridgeBio Pharma reported long term acoramidis data in transthyretin amyloid cardiomyopathy and submitted a US FDA NDA for BBP-418 in LGMD2I/R9. BBP-418 could become the first approved therapy for the disease if cleared.
Apr 09, 2026
FDA draft biosimilar guidance released March 10, 2026 removes animal toxicology and immunogenicity requirements and accepts some non-U.S. comparator data. The changes are projected to cut development costs by up to 50%.
Apr 09, 2026
The FDA accepted Replimune’s BLA resubmission for RP1 plus nivolumab in advanced melanoma. The agency set an April 10, 2026 PDUFA date under a Class II resubmission timeline.
Apr 09, 2026
Celltrion said CT-P71 received FDA Fast Track designation for previously treated locally advanced or metastatic urothelial cancer. The ADC candidate is in Phase 1 testing.
Apr 09, 2026
A paper in the New England Journal of Medicine argues the Supreme Court should reject FDA-required drug labels as standalone evidence of patent infringement in Hikma Pharmaceuticals USA v. Amarin Pharma. The paper says lower-court guidance raises liability risk for generic-drug manufacturers complying with FDA rules and could hamper competition.
Apr 09, 2026
Dr. Reddy's said the FDA accepted for review its 351(k) BLA for DRL_AB, a proposed interchangeable biosimilar to ORENCIA. The application covers an IV formulation for RA, PsA and pJIA.
Apr 08, 2026
The FDA has approved icotrokinra, the first oral IL-23 therapy for moderate-to-severe plaque psoriasis. Meanwhile, real-world research shows IL-23 inhibitors produce site-specific responses in high-impact areas like scalp and nails, and combination therapy with ixekizumab and tirzepatide shows superior results for psoriasis patients with obesity.
Apr 08, 2026
The FDA granted fast track designation to SIM0505, a CDH6-targeting antibody-drug conjugate, for platinum-resistant ovarian cancer based on preclinical and early clinical data. A phase 1 trial is currently evaluating the drug in advanced solid tumors, with initial data expected at the 2026 ASCO conference. The company plans to begin dose optimization studies in ovarian cancer patients in Q2 2026.
Apr 08, 2026
Post-mastectomy pain syndrome affects 10-50% of women after breast removal surgery, causing chronic pain that can last years. The condition lacks consistent diagnosis, standardized screening, and FDA-approved treatments, leaving many patients struggling to find relief. Recent research calls for increased focus on this undertreated complication of breast cancer survival success.
Apr 08, 2026
The FDA has approved investigational device exemptions for two major cardiovascular trials: TRiCares' Topaz transcatheter tricuspid valve replacement system pivotal study and TransMedics' OCS ENHANCE Heart trial for advanced organ preservation. The Topaz trial will evaluate the minimally invasive valve in up to 75 sites, while the TransMedics trial aims to enroll over 650 patients to compare next-generation heart preservation against traditional cold storage.
Apr 08, 2026
NanoViricides has filed regulatory applications for its antiviral candidate NV-387, seeking both Rare Pediatric Disease Drug Designation for measles treatment and Orphan Drug Designation for both measles and MPox treatments. The company could qualify for significant incentives including tax credits, fee exemptions, market exclusivity, and potentially a Priority Review Voucher worth approximately $160 million. There are currently no approved drugs for treating either measles or MPox, with both diseases showing concerning case trends.
Apr 08, 2026
The FDA approved ScinoPharm Taiwan's glatiramer acetate as the first complex injectable generic for relapsing multiple sclerosis and Sentynl Therapeutics' copper histidinate as the first treatment for pediatric Menkes disease in January 2026. These approvals represent significant advancements in neurological care, with the glatiramer acetate approval following a novel regulatory pathway and the Menkes treatment showing improved survival in early-treated patients.
Apr 07, 2026
Biopharma companies are increasingly outsourcing FDA-approved drug manufacturing to Europe despite 15% U.S. tariffs, with Europe recording triple the U.S. deal volume in 2025. Simultaneously, nearly half of pharma companies offshored R&D activities last year, citing talent access and lower costs. Major investments by companies like Novo Nordisk, Eli Lilly, and AstraZeneca highlight the ongoing shift of pharmaceutical operations overseas.
Apr 07, 2026
Biocon has launched denosumab biosimilars Bosaya and Aukelso in the United States following FDA approval with interchangeable designation. The products target osteoporosis and bone metastases, entering a market where denosumab products generated approximately $5 billion in U.S. sales in 2024. The launch represents a strategic expansion of Biocon's biosimilar portfolio amid competitive market conditions.
Apr 07, 2026
GLP-1 drugs discovered accidentally in anglerfish research now treat conditions beyond diabetes including kidney disease, sleep apnea, and addiction. The global diabetes therapeutics market is projected to reach $241.5 billion by 2030, growing at 12.4% annually.
Apr 07, 2026
Multiple therapeutic approaches targeting the APOE4 gene are advancing, including small molecule drugs, gene therapies, and repurposed medications. The APOE4 variant confers a 60% lifetime Alzheimer's risk and affects brain metabolism, increasing seizure susceptibility. Research shows blood pressure drug terazosin can reduce seizures in APOE4 models by boosting cellular energy production.
Apr 06, 2026
JAMA Neurology published Phase 2b PARADIGM results for PrimeC in ALS, showing slower functional decline, fewer ALS-related complications and longer survival. NeuroSense is preparing a Phase 3 trial and received Brazilian patent protection through October 2042.
Apr 06, 2026
NRx said the FDA outlined a path for a New Drug Application for NRX-100, a preservative-free ketamine formulation for depression with suicidality. The company plans to submit the NDA by June 2026 and said no additional nonclinical or bridging studies would be required.
Apr 06, 2026
NRx Pharmaceuticals said an FDA Type C meeting indicated a path to an NDA for NRX-100, using clinical trial results and real-world ketamine data from more than 65,000 patients.
