Latest Headlines
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New AI Tech To Speed Drug Development
4/9/2026
School of Medicine scientists have developed a bold new approach to drug development and discovery that could dramatically accelerate the creation of new medicines.
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ANI Pharmaceuticals Announces FDA Approval And Launch Of Isosorbide Mononitrate Tablet
4/8/2026
ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company launched Isosorbide Mononitrate Tablet USP, 10 mg and 20 mg. ANI’s Isosorbide Mononitrate Tablet USP is the generic version of the reference listed drug (RLD) Monoket®.
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Plus Therapeutics Granted U.S. FDA Orphan Drug Designation To REYOBIQ™ In Pediatric Malignant Gliomas
4/8/2026
Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to REYOBIQ™ (rhenium Re186 obisbemeda) for the treatment of pediatric malignant gliomas.
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Fifteen Years Alongside Europe's Drug Discovery Teams: Viva Biotech Strengthens Continuity From Discovery To Development And Manufacturing
4/7/2026
Celebrating over 15 years of collaboration alongside Europe's drug discovery community, Viva Biotech is reaffirming its commitment to the region through operational stability, sustained growth, and scalable collaboration.
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Nuvalent Announces Submission Of New Drug Application To FDA For Neladalkib In TKI Pre-Treated Advanced ALK-Positive NSCLC
4/7/2026
Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the submission to the U.S. Food and Drug Administration (FDA) of the Company's NDA for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated advanced ALK-positive NSCLC.
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Alloy Therapeutics Enters Into Multi-Target Collaboration And License Agreement With Biogen For Use Of Alloy's AntiClastic ASO Platform
4/7/2026
Alloy Therapeutics Inc. (“Alloy”), a biotechnology ecosystem company dedicated to democratizing access to cutting-edge drug discovery technologies, today announced a collaboration and license agreement with Biogen Inc. for the use of Alloy’s novel and proprietary AntiClastic ASO Platform.
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Variational AI Releases Enki 4: Major Update To Foundation Model For Small-Molecule Drug Discovery
4/7/2026
Variational AI today announced the release of Enki 4, a major update to its generative AI platform for small-molecule drug discovery.
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New Thesis Shows Methods To Map Shared Genetics And Uncover Clues For Drug Development
4/2/2026
Many common diseases and other complex traits, such as heart disease, diabetes, and psychiatric disorders, are influenced by a very large number of genetic variants, each with only a small effect.
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BioXcel Therapeutics Announces Food & Drug Administration Acceptance Of Supplemental New Drug Application For Use Of IGALMI® In The At-Home Setting
4/1/2026
BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience, today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for approval of IGALMI® for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia.
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UNC Research Contributes To FDA Approval Of New Drug For Rare Genetic Disorder
4/1/2026
A drug tested in a clinical trial at UNC, led by renowned UNC pediatric biochemical geneticist Joseph Muenzer, MD, PhD, has been approved by the U.S. Food and Drug Administration.