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🇺🇸 AmericasLatest pharmaceutical news, drug approvals, and FDA regulatory updates
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FDA Approves CardioDetect: First AI Diagnostic Tool for Arrhythmia
The FDA has approved CardioDetect, an innovative AI diagnostic tool designed to detect arrhythmias, marking a significant advancement in cardiac health technology.
Psoriasis Treatment Pipeline Explodes: 90+ Companies Race to Develop Next-Generation Therapies in 2026
Over 90 pharmaceutical companies are developing innovative psoriasis treatments, with promising therapies like Piclidenoson and Zasocitinib advancing through trials.
MeiraGTx to Present 3-Year AAV-hAQP1 Gene Therapy Data for Radiation-Induced Xerostomia Treatment
MeiraGTx will present 3-year Phase 1 AQUAx trial data for AAV-hAQP1 gene therapy treating radiation-induced xerostomia on April 16, 2026.
Corbus Pharmaceuticals CRB-913 Obesity Drug Completes Patient Enrollment in CANYON-1 Phase 1b Trial
Corbus Pharmaceuticals completes enrollment for CRB-913 obesity treatment Phase 1b trial, targeting summer 2026 results with 240 patients enrolled.
Actuate Therapeutics' Elraglusib Doubles Pancreatic Cancer Survival Rates in Nature Medicine Study
Elraglusib plus chemotherapy doubled 1-year survival rates to 44% vs 22% in metastatic pancreatic cancer patients, published in Nature Medicine.
DuPont Launches AmberChrom XT SL Chromatography Resins to Streamline Biopharmaceutical Manufacturing
DuPont introduces pre-slurried AmberChrom XT20 SL and XT30 SL chromatography resins to accelerate oligonucleotide and peptide purification workflows.
Vasa Therapeutics Partners with Eli Lilly's TuneLab AI Platform for CAMKII Inhibitor Development
Vasa Therapeutics announces partnership with Eli Lilly's TuneLab AI platform to accelerate CAMKII delta inhibitor development for cardiovascular disorders.
SynuSight Biotech's SST001 Alpha-Synuclein PET Tracer Receives NMPA Approval for Phase I Clinical Trial
SynuSight Biotech's SST001 (18F-FD4), an alpha-synuclein PET tracer for Parkinson's disease diagnosis, gets NMPA approval for Phase I clinical trial in China.
Oryon Cell Therapies Appoints Dr. Burkhard Blank as Chief Medical Officer to Lead Clinical Development
Oryon Cell Therapies names Dr. Burkhard Blank as CMO to advance clinical-stage cell therapy programs and strengthen leadership team in biotechnology sector.
Amneal Pharmaceuticals Launches First Respiratory Inhalers: Albuterol and Beclomethasone HFA Products Now Available
Amneal Pharmaceuticals launches FDA-approved albuterol sulfate and beclomethasone dipropionate HFA inhalers, marking company's entry into respiratory market.
Bright Path Applauds President's FY2027 Budget for Domestic Pharmaceutical Manufacturing Investment
Bright Path supports President's FY2027 budget proposal investing in advanced pharmaceutical manufacturing technologies to strengthen domestic medicine production capabilities.
Partner Therapeutics Submits FDA Application for BIZENGRI in Rare Cholangiocarcinoma Cancer Treatment
Partner Therapeutics submits supplemental FDA application for BIZENGRI (zenocutuzumab-zbco) to treat advanced cholangiocarcinoma with NRG1 gene fusion.
Clearmind Medicine's CMND-100 Meets Primary Endpoint in Phase I/IIa Trial for Alcohol Use Disorder
Clearmind Medicine announces CMND-100 successfully met primary endpoint in FDA-approved Phase I/IIa trial for alcohol use disorder treatment.
FDA Accepts Praxis Precision Medicines' New Drug Application for Ulixacaltamide HCl Essential Tremor Treatment
FDA accepts Praxis Precision Medicines' NDA for ulixacaltamide HCl essential tremor treatment with January 2027 PDUFA date, no advisory committee expected.
FDA Approves FILSPARI (Sparsentan) for FSGS: First Treatment for Rare Kidney Disease
Travere Therapeutics receives FDA approval for FILSPARI (sparsentan), the first approved treatment for FSGS, a rare kidney disorder leading to kidney failure.
Apotex Receives FDA Approval for First Generic Infuvite Adult Injection with 180-Day Exclusivity
Apotex Corp. secures FDA approval for generic Infuvite Adult Injection in partnership with Orbicular and Gland Pharma, gaining 180-day CGT exclusivity.
FDA Approves RARE-Cure’s Orphan Drug Enzyme Replacement Therapy
The FDA has granted approval for RARE-Cure’s enzyme replacement therapy, a groundbreaking treatment for patients with rare genetic disorders.
FDA Approves MigraEase: Faster Relief Migraine Drug Launch
MigraEase, the newly approved migraine relief medication by the FDA, promises faster relief for migraine sufferers, transforming headache management.
FDA Approves Elahere: Expanded Use for Platinum-Resistant Ovarian Cancer
The FDA has approved Elahere for expanded use in patients with platinum-resistant ovarian cancer, marking a significant advancement in treatment options.
FDA Approves CardioShield: First Drug for HFpEF Treatment
CardioShield has received FDA approval as the first treatment specifically designed for heart failure with preserved ejection fraction (HFpEF), offering new hope for patients.