Browsing Tag
US FDA
379 posts
Biotronik’s Acticor and Rivacor CRM devices bag FDA approval
Biotronik has bagged US FDA approval for its high-voltage cardiac rhythm management (CRM) devices – Acticor and Rivacor…
Biohaven secures orphan drug status for verdiperstat in MSA treatment
Connecticut-based Biohaven Pharmaceutical has received a significant regulatory boost, with the US FDA granting orphan drug designation for…
Amgen submits BLA for Infliximab biosimilar ABP 710 to FDA
Amgen Inc. has officially submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA)…
FDA greenlights Amgen’s Nplate for pediatric immune thrombocytopenia
Amgen’s Nplate (romiplostim) has received US Food and Drug Administration (FDA) approval for treating pediatric patients with immune…
Novartis’ Promacta approved by FDA for first-line treatment of severe aplastic anemia
The U.S. Food and Drug Administration (FDA) has granted an expanded indication for Novartis’ Promacta (eltrombopag), approving it…
Seattle Genetics’ Adcetris receives FDA approval for peripheral T-cell lymphoma
Seattle Genetics’ Adcetris, in combination with CHP chemotherapy, gains FDA approval for treating certain types of peripheral T-cell…
Cosmo Technologies secures FDA approval for Aemcolo to treat travelers’ diarrhea
Cosmo Technologies has achieved a significant milestone with the recent approval from the U.S. Food and Drug Administration…
4D Molecular Therapeutics’ 4D-110 receives FDA orphan drug designation for choroideremia
4D Molecular Therapeutics (4DMT), a prominent California-based gene therapy firm, has achieved a significant milestone with the US…
Pfizer’s Lorbrena receives FDA approval for advanced lung cancer treatment
Pfizer Inc., a leading US pharmaceutical company, has secured approval from the US Food and Drug Administration (FDA)…
Dupixent receives FDA approval for treatment of moderate-to-severe asthma
Sanofi and Regeneron Pharmaceuticals’ Dupixent (dupilumab) has achieved a significant milestone with the U.S. Food and Drug Administration…