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🇺🇸 AmericasLatest pharmaceutical news, drug approvals, and FDA regulatory updates
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Avaí Bio Receives First FDA Clearance for Cellular Rejuvenation Trial as Anti-Aging Market Reaches $120 Billion
Avaí Bio becomes first company to receive FDA clearance for cellular rejuvenation trial, marking milestone in $120 billion anti-aging market by 2030.
Cipla Receives FDA Approval for First Generic Ventolin HFA (Albuterol Sulfate) - AB-Rated Therapeutic Equivalent
Cipla secures FDA approval for first AB-rated generic Ventolin HFA (albuterol sulfate), offering cost-effective asthma treatment alternative to patients.
Dupixent Becomes First Biologic Approved for Chronic Spontaneous Urticaria in Children Ages 2-11
Sanofi's Dupixent receives FDA approval as first biologic treatment for chronic spontaneous urticaria in young children, expanding pediatric treatment options.
Oncology Data Landscape 2026: Key Trends & Upcoming Readouts
The 2026 oncology data landscape promises critical clinical readouts across targeted therapies, antibody-drug conjugates, and hematologic malignancies, with major conferences including ASCO and ESMO delivering transformative insights for precision medicine and treatment strategy advancement.
ReDI 2026: FDA Regulatory Strategies Conference Preview
Preview of the ReDI 2026 Conference, focusing on FDA regulatory strategies for drugs, devices, and biologics. Key topics include clinical trial innovation and electronic submissions.
BioNJ BioPartnering Conference 2026: Biotech & Partnering
The BioNJ BioPartnering Conference 2026, scheduled for May 12, 2026, in Jersey City, NJ, will connect biotech companies, investors, and industry experts. The conference features company presentations, startup pitches, and 1:1 partnering opportunities.
Fierce Biotech Week 2026: What to Expect in Boston
Fierce Biotech Week 2026 convenes biotech professionals on May 14 at Encore Boston Harbor in Boston to discuss innovation, deal-making, and investment. Expect focus on oncology, cell therapy, rare disease, and capital formation.
BioMed Israel 2026: AI & Biotech Innovations Preview
BioMed Israel 2026 will focus on AI/ML innovations in clinical development, featuring PhaseV. The conference takes place May 12-14, 2026, in Tel Aviv, Israel.
OCT East Coast 2026: CRO Trends & Outsourcing Strategies
The 17th Annual Outsourcing in Clinical Trials (OCT) East Coast 2026 event will focus on key trends in clinical outsourcing, including strengthening trial resilience and evolving CRO roles. Discussions will also address patient expectations in the trials-to-commercialization process.
INTERPHEX 2026 Biotech Day 1: Key Takeaways
INTERPHEX 2026 Day 1 highlighted critical advances in biotech manufacturing, including Avantor's scalable fluid handling technology, STERIS Life Sciences' Annex 1 compliance solutions, and modular cleanroom innovations from AES—shaping the future of pharmaceutical drug development and bioprocess manufacturing.
Alterity Therapeutics ATH434 Shows Reduced Functional Decline in Multiple System Atrophy Phase 2 Trial
ATH434 demonstrated significant reduction in functional decline versus placebo in MSA patients at 52 weeks, supporting Phase 3 development plans.
Tempest Therapeutics Achieves Manufacturing Milestone for TPST-2003 CAR-T Cancer Treatment
Tempest Therapeutics hits key manufacturing milestone for TPST-2003 dual-targeting CAR-T therapy, supporting Q4 2026 registrational study launch.
Phanes Therapeutics to Present Updated Spevatamig Phase 2 Results for Metastatic Pancreatic Cancer at ASCO 2026
Phanes Therapeutics will present updated Phase 2 clinical trial results of spevatamig (PT886) combined with chemotherapy for metastatic pancreatic cancer treatment.
NETRIS Pharma's NP137 Shows Promising Results in Pancreatic Cancer Phase 1b Trial Published in Nature
NETRIS Pharma's NP137 anti-netrin-1 antibody achieved 16.43 months median survival in locally advanced pancreatic cancer patients in Phase 1b trial.
Neurosterix NTX-253 Phase 1 Schizophrenia Trial On Track for Q2 2026 Completion
Addex spin-out Neurosterix progresses NTX-253 Phase 1 clinical study for schizophrenia treatment, targeting Q2 2026 completion milestone.
Mabwell 9MW2821 Combination Therapy Data to Be Presented at ASCO 2026 for Urothelial Carcinoma Treatment
Mabwell presents clinical data on 9MW2821 plus toripalimab combination therapy for urothelial carcinoma at ASCO 2026 Annual Meeting in Chicago.
FDA Issues Complete Response Letter for Atara Biotherapeutics' EBVALLO Cancer Treatment, Triggering Securities Lawsuit
Atara Biotherapeutics receives FDA Complete Response Letter for EBVALLO (tabelecleucel) cancer treatment, leading to securities class action lawsuit deadline.
ImmunityBio (IBRX) Faces Securities Lawsuit After FDA Warning Letter Over Cancer Treatment Claims
ImmunityBio stock plunges 21% as company faces class action lawsuit following FDA warning letter about misleading cancer treatment claims by executives.
NRx Pharmaceuticals Receives Positive FDA Feedback on Preservative-Free Ketamine Generic Drug Application
NRx Pharmaceuticals reports encouraging FDA feedback on its preservative-free ketamine program, with potential approval within current review cycle for depression treatment.
Labcorp Launches FDA-Approved PD-L1 Companion Diagnostic for KEYTRUDA Ovarian Cancer Treatment
Labcorp launches nationwide availability of FDA-approved PD-L1 IHC 22C3 pharmDx companion diagnostic to identify ovarian cancer patients eligible for KEYTRUDA treatment.