News
🇺🇸 AmericasLatest pharmaceutical news, drug approvals, and FDA regulatory updates
Latest News
FDA Places Clinical Hold on Newron's Evenamide Phase III Trial for Treatment-Resistant Schizophrenia
FDA halts enrollment in Newron's Phase III ENIGMA-TRS 2 study of evenamide for treatment-resistant schizophrenia, creating regulatory uncertainty for the novel therapy.
Teva Reports Strong Q1 2026 Results as PONLIMSI Biosimilar Receives FDA Approval and Olanzapine LAI Advances
Teva's Q1 2026 earnings show strong performance driven by PONLIMSI biosimilar FDA approval and olanzapine LAI NDA acceptance for schizophrenia treatment.
Teva Acquires Emalex Biosciences for First-in-Class Tourette Syndrome Drug Ecopipam
Teva Pharmaceutical acquires Emalex Biosciences to gain access to ecopipam, a first-in-class dopamine D1 receptor antagonist for pediatric Tourette syndrome.
Teva's PONLIMSI Biosimilar Receives FDA Approval for All Prolia Indications as Q1 2026 Results Show Strong Growth
Teva's PONLIMSI biosimilar gains FDA approval for all Prolia indications while duvakitug shows promising Phase 2b results in inflammatory bowel disease.
Bayer Presents 13 Stroke Research Abstracts at ESOC 2026, Including Asundexian Phase III Trial Data
Bayer showcases 13 stroke research abstracts at ESOC 2026, featuring late-breaking Phase III OCEANIC-STROKE trial analyses of Asundexian for stroke prevention.
Tempest Therapeutics TPST-2003 CAR-T Shows Promise for Multiple Myeloma at ISCT 2026
Tempest Therapeutics presents positive TPST-2003 dual-targeting CAR-T data for relapsed/refractory multiple myeloma patients at ISCT 2026 meeting.
Pfizer's ELREXFIO Shows Significant Progression-Free Survival Improvement in Multiple Myeloma Phase 3 Trial
Pfizer's ELREXFIO meets primary endpoint in MagnetisMM-5 Phase 3 trial, showing statistically significant progression-free survival improvement for relapsed multiple myeloma patients.
Rein Therapeutics LTI-03 Phase 2 Trial Enrolls 8 Patients for Idiopathic Pulmonary Fibrosis Treatment
Rein Therapeutics reports 8 patients enrolled in Phase 2 RENEW study of LTI-03 for idiopathic pulmonary fibrosis across US, Australia, and Poland sites.
Laguna Biotherapeutics Receives FDA Clearance for LGNA-100 Pediatric Leukemia Trial
FDA clears Laguna's IND application for LGNA-100, a novel γδ T cell activator targeting high-risk pediatric leukemias, marking key regulatory milestone.
Expression Therapeutics Receives FDA Fast Track and Rare Pediatric Disease Designations for Hemophilia A Stem Cell Therapy
Expression Therapeutics gains dual FDA designations for investigational autologous stem cell therapy targeting hemophilia A, advancing to Phase 2 trials.
FDA Grants Priority Review for Gilead's Bictegravir Plus Lenacapavir HIV Treatment Combination
Gilead Sciences receives FDA priority review for novel once-daily HIV treatment combining bictegravir and lenacapavir, potentially the smallest single-tablet regimen.
Regeneron Announces Free Gene Therapy Otarmeni for Rare Hearing Loss in U.S. Government Agreement
Regeneron will provide Otarmeni gene therapy for free in the U.S. under new government agreement to lower drug costs for rare genetic hearing loss patients.
Pharma Partnering US: Biotech Dealmaking Heats Up
Pharma Partnering US convenes biotech entrepreneurs, pharma executives, and venture investors to facilitate licensing agreements, research collaborations, and strategic partnerships shaping the drug development landscape.
COG 2024: Daily Highlights and Key Takeaways
NovaPharmaNews cannot provide verified coverage of the 4th Annual COG conference due to insufficient official documentation. This article outlines why verification is essential and directs readers to authoritative sources.
ASCO 2026: Key Oncology Data Readouts to Watch
Preview of the key oncology data readouts expected at the ASCO 2026 Annual Meeting, including late-breaking abstracts and presentations from major pharmaceutical companies.
ASCO 2026: Top Oncology Trials to Watch
A preview of the top oncology trials to watch at ASCO 2026, including lung cancer, hematologic malignancies, and gastric cancer updates. Key presentations include PROTEUS, SARC041, LIBRETTO-432, HARMONi-6, and RASolute 302.
FDA's REdI Conference 2026: Regulatory Strategies for Pharma
The FDA's REdI Annual Conference 2026 focuses on regulatory strategies for medical products, covering topics like advanced drug manufacturing and AI in drug development. The conference provides direct input from FDA experts on foundational regulatory requirements.
Pharma Partnering US: Biotech Deals and Investment Trends
Pharma Partnering US convenes biotech innovators, pharmaceutical partners, and institutional investors to negotiate licensing deals, explore strategic collaborations, and identify investment opportunities in the competitive US biopharma landscape.
Pharma Partnering US: Biotech Deals & Investment Trends Day 1
Pharma Partnering US Day 1 brought together biotech entrepreneurs, pharmaceutical executives, and venture investors to discuss partnership opportunities, emerging technologies, and investment trends shaping the US biotech landscape.
AOP Health US Treats First Patient with Rapiblyk (Landiolol) in United States at Valley Hospital
AOP Health US achieves milestone with first Rapiblyk (landiolol) patient treatment at Valley Hospital, expanding critical care options nationwide.