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Pharma News
Pharma News
CLINUVEL Receives Final EMA Scientific Advice for Phase III Vitiligo Trial
CLINUVEL announced final EMA scientific advice for the Phase III CUV107 study evaluating SCENESSE as a systemic treatment for non-segmental vitiligo.
Grace Therapeutics Receives FDA Complete Response Letter for GTx-104 NDA
The FDA issued a Complete Response Letter to Grace Therapeutics regarding the NDA for GTx-104, an investigational treatment for subarachnoid hemorrhage.
ASO Therapy Reverses Rare Neurodevelopmental Disorder Preclinical Model
St. Jude scientists reversed HNRNPH2-related neurodevelopmental disorder effects using antisense oligonucleotides in preclinical models, paving the way for trials.
FDA Grants Fast Track to BBO-11818 for Advanced KRAS-Mutant Pancreatic
BridgeBio Oncology Therapeutics receives FDA Fast Track designation for pan-KRAS inhibitor BBO-11818 for advanced KRAS-mutant pancreatic ductal adenocarcinoma.
Trevi Therapeutics Announces Closing of $173M Underwritten Public Offer
Trevi Therapeutics closes a $173 million underwritten public offering, accelerating the development of Haduvio for chronic cough and pulmonary fibrosis.
RM-055 Highlights Deep Antitumor Activity in Preclinical Cancer Models
Revolution Medicines presents preclinical data on RM-055, a mutant-targeted catalytic RAS(ON) inhibitor overcoming resistance in multiple cancer models.
Geron Reports Inducement Grants Under Nasdaq Rule 5635(c)(4) For Hires
Geron Corporation announces stock option grants to nine new employees under Nasdaq Listing Rule 5635(c)(4), supporting its blood cancer therapy development.
Sutro's Emerging ADC Pipeline Shows Promising Preclinical Data at AACR
Sutro Biopharma presents promising preclinical data at AACR for STRO-004, STRO-006, and STRO-227, highlighting its emerging high-DAR ADC pipeline progress.
Nuvalent Unveils New Zidesamtinib (NVL-520) Data at AACR 2026 for NSCLC
Nuvalent shares promising clinical data for zidesamtinib (NVL-520) at AACR 2026, targeting heavily pre-treated ROS1-positive NSCLC patients.
FDA Approves Expanded Postoperative Pain Indication for Caldolor Injection
Cumberland Pharmaceuticals secures FDA expanded indication for Caldolor (ibuprofen) injection for postoperative pain management, launching a new HCP website.
Phase 3 EPIC Trial Evaluates NRTX-1001 Cell Therapy for Drug-Resistant MTLE
The Phase 3 EPIC trial evaluates NRTX-1001, an investigational GABAergic cell therapy, as a potential single-administration approach for drug-resistant MTLE.
FDA Accepts Ultragenyx BLA for UX111 Gene Therapy to Treat Sanfilippo
FDA accepts Ultragenyx's BLA for UX111, an investigational AAV9 gene therapy for Sanfilippo syndrome Type A, with a PDUFA action date of September 19.
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