Janssen TECVAYLI gets USFDA nod for relapsed or refractory multiple myeloma Ruchika Sharma29 Oct 2022 10:00 AM ISTTECVAYLI is a first-in-class, bispecific T-cell engager antibody that is administered as a subcutaneous treatment.
Glenmark Baddi facility placed under import alert by USFDA Ruchika Sharma28 Oct 2022 11:28 AM ISTGlenmark said it will engage with the agency to resolve the import alert at the earliest.
Zydus Pain relief drug Ketorolac Tromethamine gets USFDA approval Ruchika Sharma27 Oct 2022 5:00 PM ISTAhmedabad: Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and Drug...
Alembic Pharma Vadodara facility concludes USFDA inspection with zero observations Ruchika Sharma27 Oct 2022 1:30 PM ISTVadodara: Alembic Pharma has recently announced that the Company has successfully completed the United States Food and Drug Administration...
Zydus Lifesciences bags USFDA okay for Fungal infection treatment Ruchika Sharma27 Oct 2022 12:30 PM ISTAhmedabad: Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and Drug...
Alembic Pharma gets USFDA nod for cancer injection Paclitaxel Ruchika Sharma27 Oct 2022 11:36 AM ISTPaclitaxel Injection, USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse...
Regeneron gets six months of US pediatric exclusivity for Eylea injection Ruchika Sharma23 Oct 2022 3:30 PM ISTEYLEA is a VEGF inhibitor formulated as an injection for the eye
USFDA grants emergency use nod for Novavax COVID vaccine,Adjuvanted as booster for adults Ruchika Sharma20 Oct 2022 5:46 PM ISTGaithersburg: Novavax, Inc. has announced that the company's COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization (EUA)...
Lupin gets 17 USFDA observations for Pune facility Ruchika Sharma20 Oct 2022 11:20 AM IST"The Company does not believe that the 483 letter will have an impact on the existing revenues from operations of this facility," Lupin stated.
Alembic Pharma Panelav facility gets 4 USFDA observations Ruchika Sharma19 Oct 2022 12:00 PM ISTVadodara: Drugmaker, Alembic Pharma, has recently announced that the United States Food and Drug Administration (USFDA) has issued a Form 483 with 4...
USFDA nod to GSK Menveo in new single-vial presentation to prevent invasive meningococcal disease Ruchika Sharma18 Oct 2022 10:00 AM IST"The Menveo one-vial presentation now comes in a ready to use single vial giving healthcare providers a more convenient option," GSK stated.
Zydus Pharma Roflumilast Tablets bags USFDA okay to treat COPD exacerbations Ruchika Sharma17 Oct 2022 3:30 PM ISTChronic obstructive pulmonary disease (COPD) is a common, preventable and treatable chronic lung disease which affects men and women worldwide.
