Last edition
News about
FDA Acknowledges Pain Reduction Data Supporting Rexlemestrocel-L Efficacy
The US Food and Drug Administration (FDA) has acknowledged clinical data showing that Rexlemestrocel-L reduced pain intensity over 12 months, supporting the product’s efficacy in treating back pain. The agency also indicated that the approval label may include language related to opioid reduction.
D3 Bio has received FDA IND clearance to initiate a Phase I trial of its KRAS G12D inhibitor D3S-003 and a Phase II combination study targeting KRAS G12C-mutant lung cancer.
Agno Pharma Acquires Actylis's CDMO Manufacturing Asset
Agno Pharma has acquired Actylis’s CDMO manufacturing asset, the legacy Cascade Chemistry business based in Eugene, Oregon, strengthening Agno’s U. cGMP API development and manufacturing capabilities.
Harbour BioMed has exercised its warrant to acquire shares in Spruce Biosciences, securing a 3.8 percent stake and deepening their collaboration to advance SPR202 for rare endocrine and immune disorders.
Rakuten Medical and LOTTE Biologics Sign Manufacturing Deal for Global Oncology Programme
Rakuten Medical has entered into a manufacturing agreement with LOTTE Biologics under which LOTTE Biologics will provide advanced manufacturing services for monoclonal antibody intermediates and their conjugates, supporting Rakuten Medical’s global clinical development programmes and future commercialisation in oncology.
UK MHRA Approves up to 7.2 mg Dose of Semaglutide for Obesity Treatment
The UK MHRA has approved a higher dose of semaglutide of up to 7.2 mg for weight management in adult patients with obesity. The regimen involves three 2.4 mg injections and is indicated for use alongside a reduced-calorie diet and increased physical activity in adults with a Body Mass Index (BMI) of 30 kg/m² or higher.
IDT- Ansa Alliance Brings High-Complexity, Long-Length DNA Synthesis to Global Researchers
Integrated DNA Technologies (IDT), a Danaher company and a global genomics solutions provider, has entered into a strategic collaboration with Ansa Biotechnologies Inc to enhance its synthetic biology portfolio with advanced DNA synthesis capabilities.
BD Secures FDA 510(k) Clearance for EnCor EnCompass Multi-Modality Breast Biopsy System
BD has received FDA 510(k) clearance for its EnCor EnCompass multi-modality breast biopsy system, designed to improve procedural efficiency, clinician flexibility and early detection and diagnosis of breast disease.
China's NMPA Approves Sanofi-Licensed Myqorzo and Redemplo for Rare Cardiac and Lipid Disorders
Myqorzo and Redemplo approvals by NMPA expand treatment options for obstructive hypertrophic cardiomyopathy and familial chylomicronaemia syndrome in adult patients across Greater China.
Atossa Therapeutics Receives FDA Orphan Drug Designation for Duchenne Therapy
Atossa Therapeutics has received US Food and Drug Administration (FDA) Orphan Drug Designation (ODD) for (Z)-Endoxifen for the treatment of Duchenne Muscular Dystrophy, further supporting the company’s development programme in rare paediatric neuromuscular diseases.
We use our own and third party cookies to produce statistical information and show you personalized advertising by analyzing your browsing, according to our COOKIES POLICY. If you continue visiting our Site, you accept its use.
More information: Privacy Policy