Artes Medical recently announced that the FDA has approved its product ArteFill as the first nonresorbable injectable filler to correct nasolabial fold rhytides. ArteFill is the first product that is a permanent support structure for continuing correction of these rhytides. FDA approval is based on ...
The generic liraglutide option for Victoza was approved by the FDA on December 23, 2024. The generic is only approved to be used to improve blood sugar control in type 2 diabetes (as an adjunct to diet and exercise), but it may also lead to some weight loss....
Shanghai, China, September 29th, 2022 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug (IND) application for its HLX07 (recombinant anti-EGFR humanized monoclonal antibody injection) ...
Obinutuzumab (Gazyva) plus bendamustine, followed by obinutuzumab alone has been approved by the FDA as a treatment of patients with follicular lymphoma who were not responsive to a rituximab regimen, or who relapsed after rituximab-based therapy.
Epkinly™ (epcoritamab-bysp) approved by US Food and Drug Administration as the first and only bispecific antibody to treat adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). News release. May...
The Company’s API site at Changzhou underwent a GMP surveillance inspection by the FDA that began on March 4. Covering 21 FDA-approved products, the inspection followed the FDA’s six-system inspection model. The FDA inspectors concluded the review one day ahead of schedule. No observation was...
Chimeric antigen receptor T-cell therapy or CAR-T-cell therapy in short, which is developed by a company in Jiangning High-tech Zone, Nanjing, has been approved for marketing by the FDA of the USA. The first CAR-T-cell therapy product independently developed by China and to be marketed ov...
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As of this article's acceptance for publication in Plastic and Reconstructive Surgery, ArteFill, a product of Artes Medical, had not yet been approved by the FDA. For further informa- tion, please visit the following Web sites: www... G Lemperle,PP Rullan,N Gauthier-Hazan - 《Plastic & ...
The FDA has approved the AspireAssist obesity-treatment device, which will allow patients to drain part of their stomach contents after each meal.