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🇺🇸 AmericasLatest pharmaceutical news, drug approvals, and FDA regulatory updates
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Veloxis Pharmaceuticals' Pegrizeprument Receives FDA Orphan Drug Designation for Heart Transplant Rejection Prevention
Veloxis Pharmaceuticals announces FDA orphan drug designation for pegrizeprument (VEL-101) to prevent heart transplant rejection in patients.
Dupixent Becomes First Biologic Approved for Children Ages 2-11 with Chronic Spontaneous Urticaria
Sanofi's Dupixent receives FDA approval as first biologic treatment for young children with uncontrolled chronic spontaneous urticaria, expanding pediatric options.
AACR 2026: ctDNA, Immunotherapy, and KRAS Target Breakthroughs
AACR 2026 in San Diego showcased transformative advances in precision oncology, including circulating tumor DNA surveillance for early-stage breast cancer, daraxonrasib achieving 58% response rates in KRAS-mutant pancreatic cancer, and next-generation CAR-T cells demonstrating deeper responses in multiple myeloma.
Denali Therapeutics Receives FDA Approval for Avlayah (Tividenofusp Alfa) to Treat Hunter Syndrome
Denali Therapeutics announces FDA approval of Avlayah (tividenofusp alfa), the first blood-brain barrier penetrating therapy for Hunter syndrome patients.
Pfizer Presents LORBRENA and BRAFTOVI Cancer Trial Updates at ASCO 2026
Pfizer showcases oncology pipeline at ASCO 2026 with new LORBRENA data for ALK-positive lung cancer and BRAFTOVI results for BRAF-mutant colorectal cancer.
Capricor Therapeutics Presents Phase 3 HOPE-3 Trial Results for Deramiocel in Duchenne Muscular Dystrophy at AAN 2026
Capricor Therapeutics announced Phase 3 HOPE-3 trial data for Deramiocel, a cell-based therapy for Duchenne muscular dystrophy, at AAN 2026 meeting.
Boston Scientific Reports Strong Q1 2026 Results with $5.2 Billion Revenue, 11.6% Growth
Boston Scientific delivered $5.203 billion in Q1 2026 net sales, marking 11.6% reported growth driven by category leadership strategy and global expansion.
Ractigen Therapeutics RAG-17 Shows 81% Reduction in ALS Biomarker in Phase I Trial
Ractigen's RAG-17 demonstrates 81% reduction in neurofilament light chain biomarker in SOD1-ALS patients with single intrathecal dose in Phase I trial.
Avacta's AVA6103 Cancer Drug Shows Superior Profile vs Enhertu in AACR 2026 Data
Avacta presents promising AVA6103 data at AACR 2026, showing robust activity in low FAP expression tumors and favorable kinetics vs marketed ADC Enhertu.
Innovent Biologics IBI363 Clinical Data to Be Presented at ASCO 2026 Annual Meeting
Innovent Biologics announces new clinical data for IBI363, a PD-1/IL-2α bispecific fusion protein immunotherapy, will be presented at ASCO 2026.
FDA Extends Sanofi Sarclisa Subcutaneous Review by Three Months for Multiple Myeloma Treatment
FDA extends Sarclisa subcutaneous review by 3 months. Sanofi's multiple myeloma treatment seeks approval across all current IV indications.
NRx Pharmaceuticals Receives Positive FDA Feedback on Preservative-Free Ketamine Generic Drug Application
NRx Pharmaceuticals reports positive FDA review of preservative-free ketamine program with only minor administrative changes requested for approval.
Lupin Launches Generic Dapagliflozin-Metformin XR Tablets in US as Xigduo XR Alternative
Lupin Limited launches FDA-approved generic dapagliflozin-metformin extended-release tablets in four strengths as bioequivalent alternative to Xigduo XR.
Sanofi's Tzield Approved by FDA for Children as Young as 1 Year to Delay Type 1 Diabetes Progression
FDA expands Tzield approval for children aged 1+ with stage 2 type 1 diabetes, marking first disease-modifying therapy to delay insulin dependence.
FDA Approves Sanofi's Tzield for Children Age 1+ to Delay Type 1 Diabetes Onset
Sanofi's Tzield becomes first disease-modifying therapy approved for children as young as one year old to delay insulin-dependent Type 1 diabetes progression.
Generic Drug Forum: Key Takeaways for US Market Access
The Generic Drugs Forum 2026 convened industry stakeholders to address critical challenges in the US generic pharmaceutical market, emphasizing regulatory modernization, supply chain transparency, and manufacturing innovation as essential pillars for sustained market access.
INTERPHEX 2026: Biotech Innovations Day 1 Roundup
INTERPHEX 2026 opened with industry focus on biotech manufacturing innovations, digital transformation in drug development, and regulatory compliance strategies for emerging pharmaceutical manufacturing technologies.
AACR 2024: Daily Oncology Research Roundup
AACR 2024 daily oncology roundup requires verified clinical trial data, drug names (INN), and speaker attribution to meet editorial standards. NovaPharmaNews cannot report on cancer treatment advances without primary source verification.
Generic Drugs Forum 2026: FDA Event Opens Amid Supply Chain Concerns
The FDA's Generic Drugs Forum 2026 convenes April 22–23 to address supply chain transparency, regulatory efficiency, and sourcing risks amid pending state-level legislation and CMS prior authorization reforms.
INTERPHEX 2026: Avantor, BioLife Solutions, AES Highlights
INTERPHEX 2026 saw Avantor unify its Masterflex portfolio, BioLife Solutions win an award for CellSeal CryoCase, and AES Cleanroom Technology celebrate 40 years with key ATMP approvals.