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Verve Therapeutics (NASDAQ:VERV) exploded higher Tuesday after releasing encouraging early-stage clinical data for its experimental gene-editing treatment VERVE-102, aimed at treating heterozygous familial hypercholesterolemia (HeFH) and premature coronary artery disease.
The U.S. Food and Drug Administration (FDA) has approved the VYVGART® Hytrulo prefilled syringe for self-injection, offering a new level of convenience and autonomy for adult patients diagnosed with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive, as well as those …
Pharmaceutical giant Novartis (NYSE:NVS) announced on Thursday that it will invest $23 billion over the next five years to significantly expand its U.S. operations, reinforcing its commitment to American drug manufacturing as the industry faces growing uncertainty over potential tariffs.
Palisade Bio, Inc. (NASDAQ: PALI), a clinical-stage biopharmaceutical company focused on autoimmune, inflammatory, and fibrotic diseases, has announced the completion of enrollment and dosing across multiple cohorts in its ongoing Phase 1a/b study of PALI-2108 for the treatment of Ulcerative Colitis (UC). This includes …
Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) has announced the completion of participant enrollment in its Phase 2a clinical trial for LP-310, a liposomal tacrolimus oral rinse designed to treat oral lichen planus (OLP), a condition that currently has no FDA-approved treatments. This trial, which includes …
CureVac N.V. (Nasdaq: CVAC), a biotechnology company focused on mRNA-based medicines, announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for a Phase 1 clinical study of CVHNLC. This therapy is an mRNA-based precision immunotherapy designed …
Mesoblast (Nasdaq: MESO) has confirmed that its allogeneic cellular products, including Ryoncil® and Revascor®, will be exempt from U.S. tariffs. This exemption is made possible because the company’s products are designated as “U.S. Country of Origin” products. All products are manufactured using U.S. donors …
Telix Pharmaceuticals (ASX/NASDAQ: TLX) has appointed Anne Whitaker as a Non-Executive Director, effective April 7, 2025. Whitaker's appointment brings a wealth of knowledge and experience to the company, stemming from over three decades in the pharmaceutical, biotech, and specialty pharmaceutical sectors.
Eli Lilly and Company (NYSE:LLY) has announced positive Phase 2 results for lepodisiran, an investigational small interfering RNA (siRNA) therapy designed to lower lipoprotein(a) [Lp(a)] levels, a genetic risk factor for cardiovascular disease. The ALPACA study results confirm that lepodisiran successfully met its primary …
Mesoblast (Nasdaq:MESO; ASX:MSB), a global leader in allogeneic cellular medicines, has announced a major milestone for its FDA-approved mesenchymal stromal cell (MSC) therapy, Ryoncil® (remestemcel-L). The company has entered into a National Drug Rebate Agreement (NDRA) with the U.S. Centers for Medicare & Medicaid …
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