FDA Approves New Prostate Cancer Imaging Agent Gozellix®
Gozellix®, after radiolabeling with 68 Ga, is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive ...
HUTCHMED Announces NMPA Conditional Approval for TAZVERIK® (tazemetostat) for the Treatment of Relapsed or Refractory Follicular Lymphoma
TAZVERIK ® is a registered trademark of Epizyme Inc., an Ipsen company.
NANOBIOTIX Announces Presentation of Data From Two Phase 1 Studies Evaluating JNJ-1900 (NBTXR3) at the European Lung Cancer Conference
Data evaluating safety and early signals of efficacy including updated local PFS from the completed dose escalation part of a Phase 1 study of ...
Rhythm Pharmaceuticals Reacquires Licensing Rights to IMCIVREE® (setmelanotide) in China with Termination of Agreement with RareStone Ltd.
Under the agreement, Rhythm has agreed to repay $6.3 million in cash to RareStone. Rhythm also agreed to return all shares of RareStone that were acquired under the original agreement for no ...
Windtree Announces License and Supply Agreement to Become Sourcing Partner for a Small Biotech with an FDA Approved Product
Windtree has manufacturing contacts that we believe are capable of reducing pharmaceutical product cost of goods for PHEXXI. Pursuant to the License and Supply Agreement, Windtree will serve as the ...
Second Data Safety Monitoring Board Issues Positive Recommendation to Continue BriaCell’s Phase 3 Study in Metastatic Breast Cancer
The Data Safety Monitoring Board (DSMB) identified no safety concerns, and recommended continuation of BriaCell’s pivotal Phase 3 study of ...
Wugen Announces Dosing of First Patients in Pivotal Trial of Off-the-Shelf, Allogeneic, CD7-Targeted CAR-T Cell Therapy WU-CART-007
Previously reported Phase 1/2 data on WU-CART-007 demonstrated clinically manageable safety and evidence of anti-leukemic activity with an ...
ARS Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates
Cash Position & Operating Runway : As of December 31, 2024, ARS Pharma had cash, cash equivalents, and short-term investments of $314.0 million, with 97,954,172 shares of common stock outstanding. The ...
Paratek Pharmaceuticals to Acquire Optinose, Creating Significant Commercial Expansion Opportunities for XHANCE® in Chronic Rhinosinusitis (CRS)
Paratek will accelerate access for XHANCE beyond specialists to primary care providers maximizing the recent label expansion for CRS in a ...
Rhythm Pharmaceuticals Announces Orphan Drug Designation Granted to Setmelanotide for Treatment of Hypothalamic Obesity in Japan
Setmelanotide is a melanocortin-4 receptor (MC4R) agonist designed to treat hyperphagia and obesity. Rhythm is evaluating setmelanotide in a global Phase 3 trial in patients with acquired hypothalamic ...
scPharmaceuticals Inc. Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
Pharmaceuticals generated fourth quarter 2024 net FUROSCIX® revenue of $12.2 million, and full year 2024 revenue of $36.3 millionCash and cash ...
FDA Clears Magstim Transcranial Magnetic Stimulation System for U.S. Adolescent Patient Treatment
This FDA clearance for the Magstim Horizon 3.0 and Inspire systems builds on the existing patient TMS clearances for adult patients, making it possible for physicians and nurse practitioners to treat ...