Lupin Launches Eslicarbazepine Acetate Tablets in the United States
Lupin has launched its US FDA-approved generic Eslicarbazepine Acetate Tablets in 200 mg, 400 mg, 600 mg, and 800 mg strengths in the US.
Global Pharma | 07/05/2025 | By Manvi
SK bioscience Chosen for KDCA's Pandemic Preparedness R&D Program
SK bioscience announced that it has been selected for the Korea Disease Control and Prevention Agency (KDCA)'s Priority Infectious Disease Pandemic Preparedness Rapid R&D Support Program.
Global Pharma | 07/05/2025 | By Manvi
AliveCor Launches AI-Powered KardiaMobile 6L Max with Smart Heart Alerts
With KardiaMobile 6L Max and KardiaAlert, users gain access to technology and tools that offer more detections and insights, monitor heart rhythm for potential changes over time, and alert patients–helping them take action.
Global Pharma | 07/05/2025 | By Manvi
Gautam Shah Takes Over as President US Operations of Senores Pharmaceuticals
US subsidiary of Senores Pharmaceuticals, Havix Group Inc. D/B/A Aavis Pharmaceuticals, with the appointment of Gautam Shah as President of US Operations plans to scale new heights and expand their business
Global Pharma | 07/05/2025 | By Manvi
IDEAYA Biosciences Secures US FDA IND-Clearance for IDE849
IDEAYA Biosciences has received FDA clearance to initiate a Phase 1 trial of IDE849, a potential first-in-class DLL3-targeting antibody-drug conjugate for advanced solid tumours, including small cell lung cancer.
Global Pharma | 06/05/2025 | By Manvi
Senores Pharmaceuticals Acquires ANDA for Topiramate Tablets from Wockhardt
Senores Pharmaceuticals Ltd., via its US subsidiary, has acquired the USFDA-approved ANDA for Topiramate tablets from Wockhardt Ltd., marking a strategic expansion into the USD 111 million US epilepsy and migraine drug market.
Global Pharma | 06/05/2025 | By Manvi
Human Longevity Adds Avantect Test to Boost Early Pancreatic Cancer Detection
This groundbreaking DNA-based blood test is designed to detect early-stage pancreatic cancer. When integrated with HLI's proprietary whole genome sequencing platform and cutting-edge MRI imaging, it offers one of the most advanced early cancer detection strategies available today.
Global Pharma | 06/05/2025 | By Manvi
FDA Lists Leo Cancer Care's Marie Particle Therapy System as Pending
The Food and Drug Administration Agency (FDA) has updated the regulatory status of Marie®, Leo Cancer Care's upright particle therapy solution, to pending. Marie combines Leo Cancer Care's upright patient positioning system with their upright fan beam CT scanner and can be utilized with any fixed particle beam.
Global Pharma | 06/05/2025 | By Manvi
Biocon Biologics Secures Market Access Coverage for Yesintek in United States
Biocon Biologics has secured market access agreements covering over 100 million lives in the US for Yesintek, its FDA-approved biosimilar to Stelara, marking a major milestone in its US biosimilars launch.
Global Pharma | 05/05/2025 | By Manvi
The FDA application is based on results from OASIS 4, a 64-week phase 3 randomized, controlled trial evaluating the efficacy and safety of once-daily oral semaglutide 25 mg versus placebo in 307 adults with obesity (BMI >/= 30 kg/m2) or overweight (BMI >/= 27 kg/m2) with one or more comorbidities. Patients with diabetes were excluded.
Global Pharma | 05/05/2025 | By Manvi
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