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2026
Pharma News, 2026
FDA Approves Partner Therapeutics' Bizengri for Rare Bile Duct Cancer
The FDA has approved Partner Therapeutics' Bizengri for adults with a rare form of advanced bile duct cancer under a new Fast-Track review program.
Viridian’s Elegrobart Shows Positive Phase 3 Results for Chronic TED Care
Viridian Therapeutics reports positive Phase 3 REVEAL-2 data for elegrobart, a subcutaneous IGF-1R antibody for chronic thyroid eye disease (TED).
Tvardi Therapeutics Bets on STAT3 Inhibitors as Cash Runway Narrows Fast
Tvardi Therapeutics faces a critical juncture with its STAT3 inhibitors, TTI-101 and TTI-109, as clinical readouts align with a narrowing cash runway.
Ernexa's ERNA-101 Shows 100% Survival in Ovarian Cancer Preclinical Data
Ernexa Therapeutics announced preclinical data showing ERNA-101 combined with PD-1 blockade achieved complete tumor clearance in ovarian cancer models.
Angelini Pharma Acquires Catalyst Pharma for $4.1B to Enter U.S. Market
Italy's Angelini Pharma has agreed to acquire Catalyst Pharma for up to $4.1 billion, gaining FDA-approved neurological drugs and entering the U.S. market.
Daiichi Sankyo & Waiv Partner to Discover ADC Biomarkers Using AI Tech
Daiichi Sankyo partnered with Waiv to leverage its AI computational pathology platform for ADC biomarker discovery, aiming to enhance clinical trial success.
City Therapeutics Unveils CITY-RBP4 RNAi Data for Stargardt at ARVO 26
City Therapeutics presented preclinical data at ARVO 2026 for CITY-RBP4, an RNAi therapy showing potent RBP4 silencing to treat Stargardt disease type 1.
NanoViricides' NV-387 Granted FDA Orphan Drug Status for Measles Target
The FDA granted NanoViricides' NV-387 Orphan Drug Designation for measles, providing seven years of market exclusivity and potential priority review benefits.
Evotec and Almirall Nominate First Preclinical Dermatology Candidate
Evotec and Almirall announce their first preclinical development candidate for immune-mediated skin diseases, leveraging an advanced AI discovery platform.
FDA Grants Breakthrough Status to Terns Pharma's CML Therapy TERN-701
The FDA has awarded breakthrough therapy designation to TERN-701 for chronic myeloid leukemia, following Merck's $6.7 billion acquisition of Terns Pharma.
Can-Fite's Namodenoson Yields Positive Data in Pancreatic Cancer Trial
Can-Fite reports promising Phase 2 data for namodenoson in advanced pancreatic cancer, showing durable disease stabilization and a strong safety profile.
Clene Advances ALS Drug CNM-Au8 Toward Accelerated FDA NDA Submission
Clene Inc. plans an accelerated FDA NDA filing for its ALS drug CNM-Au8 by Q3 2026, driven by NfL biomarker data and aiming to address urgent patient needs.
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