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🇺🇸 AmericasLatest pharmaceutical news, drug approvals, and FDA regulatory updates
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Viatris Presents Six Studies on Low-Dose Estrogen Contraceptive Patch at ACOG 2026
Viatris showcases clinical data for investigational weekly contraceptive patch at American College of Obstetricians and Gynecologists meeting May 1-3.
Axsome Therapeutics Receives FDA Approval for AUVELITY to Treat Alzheimer's Agitation - First-in-Class Breakthrough
Axsome Therapeutics announces FDA approval of AUVELITY for Alzheimer's agitation, marking first-in-class treatment for critical unmet medical need.
FDA Approves Incyte's Jakafi XR Extended-Release Tablets for Myelofibrosis, Polycythemia Vera, and GVHD Treatment
Incyte receives FDA approval for Jakafi XR (ruxolitinib) extended-release tablets, offering improved dosing convenience for rare blood disorders and GVHD patients.
Arvinas Receives FDA Approval for VEPPANU (Vepdegestrant), First PROTAC Drug for ESR1-Mutated Breast Cancer
Arvinas announces FDA approval of VEPPANU, the first PROTAC protein degrader for ESR1-mutated, ER+/HER2- advanced breast cancer treatment.
Moderna FDA Talks Focus on Phase 4 COVID Vaccine Data
Moderna is currently in discussions with the U.S. Food and Drug Administration (FDA) regarding the submission of Phase 4 data for its COVID-19 vaccine, mRNA-1273. These talks are crucial for understanding the vaccine's ongoing real-world effectiveness and post-marketing surveillance.
The Common Fund Data Ecosystem (CFDE)
The CFDE integrates diverse NIH datasets, offering access to over 10 million files to enhance biomedical research and discovery.
MRM Health's MH002 Receives FDA Fast Track Designation for Ulcerative Colitis Treatment
MRM Health's lead microbiome therapeutic MH002 granted FDA Fast Track status for mild-to-moderate ulcerative colitis, accelerating development timeline.
Cadrenal Therapeutics CAD-1005 Gets FDA Guidance for Phase 3 Trial in Heparin-Induced Thrombocytopenia
Cadrenal Therapeutics receives FDA guidance to advance CAD-1005 to Phase 3 for HIT after Phase 2 showed 25% reduction in blood clots when added to standard care.
RedHill's RHB-204 Shows Comparable Efficacy to RHB-104 in Crohn's Disease MAP Treatment Development
RedHill's next-generation RHB-204 demonstrates comparable MAP-killing efficacy to RHB-104, advancing development for Crohn's disease treatment.
Phathom Pharmaceuticals VOQUEZNA Sales Surge 104% in Q1 2026, Company Maintains Profitability Guidance
Phathom Pharmaceuticals reports $58.3M Q1 revenue from VOQUEZNA, up 104% year-over-year, with 1.35M prescriptions filled and profitability expected Q3 2026.
Contineum Therapeutics PIPE-791 Shows Positive Phase 1b Results for Chronic Osteoarthritis Pain
Contineum Therapeutics reports positive Phase 1b trial data for PIPE-791, a non-opioid LPA1 receptor antagonist for chronic osteoarthritis pain treatment.
Summit Therapeutics Ivonescimab Shows Overall Survival Benefit in Lung Cancer, ASCO 2026 Plenary Data Expected
Summit Therapeutics reports overall survival data for ivonescimab in first-line squamous NSCLC will be featured at ASCO 2026 plenary session as late-breaking abstract.
AC Immune Advances ACI-24 Alzheimer's Trial to Final Cohort, Initiates ACI-19764 Phase 1 Study
AC Immune progresses ACI-24 Alzheimer's treatment to final trial phase while starting new brain-penetrant NLRP3 inhibitor study in Q1 2026 update.
Addex Advances Dipraglurant for Brain Injury Recovery, Reports 2025 Financial Results
Addex repositions dipraglurant mGlu5 NAM for brain injury recovery while advancing GABAB PAM chronic cough candidate toward clinical trials in 2025 update.
AC Immune Initiates Final Cohort in Phase 1b/2 ABATE Trial for Anti-Abeta Alzheimer's Treatment
AC Immune begins final patient cohort in ABATE trial testing anti-Abeta immunotherapy for Alzheimer's disease, triggering $12M milestone payment.
Mabwell 9MW2821 Cervical Cancer Data to Be Presented at ESMO GC 2026 Conference
Mabwell announces presentation of clinical trial data for 9MW2821, a novel Nectin-4 targeting ADC for cervical cancer treatment at ESMO GC 2026.
Aquestive Therapeutics Faces Securities Fraud Lawsuit Despite Anaphylm FDA Review Progress
Aquestive Therapeutics hit with class action lawsuit alleging misleading investor communications about Anaphylm sublingual film FDA approval timeline.
ImmunityBio (IBRX) Faces FDA Warning Letter and Class Action Lawsuit Over Ankt Drug Promotion Violations
ImmunityBio faces securities lawsuit after FDA warning letter over promotional claims for lead biologic Ankt, impacting IBRX stock from January-March 2026.
FDA Advisory Committee Recommends AstraZeneca's TRUQAP for PTEN-Deficient Prostate Cancer
FDA Advisory Committee votes 7-1 to recommend AstraZeneca's TRUQAP (capivasertib) for PTEN-deficient metastatic hormone-sensitive prostate cancer patients.
Eli Lilly's Foundayo (Orforglipron) Receives FDA Approval for Obesity Treatment as Company Reports Strong Q1 2026 Results
Eli Lilly announces FDA approval of Foundayo (orforglipron) for obesity treatment alongside positive Phase 3 results and raised full-year guidance in Q1 2026.