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Feb 28, 2026
Next-generation in vivo CAR-T therapy enables cancer treatment with a single injection, while new Texas legislation and community-based delivery models expand patient access to this advanced cellular therapy.
Feb 28, 2026
The FDA has granted accelerated approval for YUVIWEL (navepegritide), the first once-weekly treatment for children with achondroplasia. Commercial availability is expected in early Q2 2026, with a Rare Pediatric Disease Priority Review Voucher granted.
Feb 28, 2026
NRx Pharmaceuticals completed an in-person FDA Type C meeting regarding NRX-100, a preservative-free ketamine formulation for suicidal depression. The company received guidance on a path to file a New Drug Application based on existing trial data and Real World Evidence from over 65,000 patients.
Feb 28, 2026
Sanofi receives FDA approval for Dupixent to treat allergic fungal rhinosinusitis and gains European endorsement for Acoziborole Winthrop as a sleeping sickness treatment, which will be donated to WHO.
Feb 28, 2026
Bristol Myers Squibb reported fourth quarter and full year 2025 results that beat consensus expectations, with total revenues of $48.3 billion. The company announced FDA acceptance of its new drug application for iberdomide and positive Phase 2 results for Reblozyl.
Feb 28, 2026
INmune Bio announced FDA alignment on Phase III registration program for XPro1595 in Alzheimer's disease and submitted regulatory packages for CORDStrom in rare disease treatment, marking key milestones toward commercialization.
Feb 28, 2026
The FDA removed the clinical hold on Intellia Therapeutics' MAGNITUDE-2 Phase 3 trial of nexiguran ziclumeran for ATTRv-PN, allowing patient enrollment and dosing to resume with enhanced safety monitoring.
Feb 28, 2026
Insmed reported total revenues of $606.4 million for 2025, with ARIKAYCE growing 19% annually. The FDA granted orphan drug designation to treprostinil palmitil for pulmonary arterial hypertension treatment in January 2026.
Feb 27, 2026
Pharmaceutical companies are increasingly partnering with biotechs developing RNA-targeting small molecules, driven by advances in RNA structural biology and the success of drugs like Roche's Evrysdi. The approach aims to address "undruggable" targets while offering oral availability advantages.
Feb 27, 2026
Zydus Lifesciences received USFDA final approval for 32 mg bosentan tablets for pediatric PAH and Ammonium Lactate Cream, 12%, while launching an affordable respiratory device in India.
Feb 27, 2026
Abbott India will commercialize semaglutide, the diabetes drug behind Ozempic, under the brand name Extensior in India following a partnership with Novo Nordisk. The launch targets India's growing diabetes population of over 100 million people.
Feb 27, 2026
Summit Therapeutics will participate in three investor conferences in March 2026, following FDA acceptance of its BLA for ivonescimab in lung cancer with a PDUFA date of November 14, 2026.
Feb 27, 2026
The FDA reversed an earlier refusal and agreed to review Moderna's seasonal flu vaccine application after the company revised its approach based on age groups, setting a decision date of August 5, 2026.
Feb 27, 2026
Zydus Lifesciences launched ANYRA, India's first indigenous Aflibercept biosimilar for retinal conditions, and secured approval for a March 2026 day-one launch of generic semaglutide for diabetes and obesity treatment.
Feb 27, 2026
Moderna announced UK authorization for its updated Spikevax vaccine targeting the LP.8.1 variant and European Commission marketing authorization for mNEXSPIKE, its third vaccine approved in the EU.
Feb 27, 2026
The FDA announced plans to restrict GLP-1 active pharmaceutical ingredients for compounded drugs and combat misleading advertising, following the Trump administration's launch of TrumpRx and ongoing enforcement actions against compounding pharmacies.
Feb 27, 2026
Izalontamab brengitecan demonstrated statistically significant improvements in progression-free survival and overall survival compared to chemotherapy in patients with previously treated metastatic triple-negative breast cancer, marking the third Phase III success for the bispecific ADC.
Feb 27, 2026
Novel CELMoD agents are being evaluated to address T-cell exhaustion in multiple myeloma patients, while CAR T-cell therapy CARVYKTI shows longer-term survival benefits. Nearly 200,000 people in the U.S. live with this blood cancer.
Feb 27, 2026
ImmunityBio completed enrollment of 366 patients in its Phase 2 trial of ANKTIVA plus BCG versus BCG alone for BCG-naïve bladder cancer. Interim analysis showed statistically significant improvement in duration of complete response, with the company anticipating a BLA submission by Q4 2026.
Feb 27, 2026
Merck announced Phase 3 trial results for its investigational once-daily, two-drug HIV regimen doravirine/islatravir at CROI 2026, demonstrating non-inferiority to standard treatment in treatment-naïve adults with viral suppression rates of 91.8% at Week 48.
