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Results For "FDA"

1763 News Found

Shilpa Biologicals files Type IV DMF of recombinant Human Albumin 20% with USFDA
Drug Approval | June 06, 2024

Shilpa Biologicals files Type IV DMF of recombinant Human Albumin 20% with USFDA

This novel recombinant has been developed and is a patented novel recombinant Human Albumin 20% process


Moderna receives U.S. FDA approval for RSV Vaccine mRESVIA
Drug Approval | June 01, 2024

Moderna receives U.S. FDA approval for RSV Vaccine mRESVIA

mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes


BlueRock Therapeutics receives FDA RMAT designation for Parkinson’s disease cell therapy candidate bemdaneprocel
Drug Approval | May 31, 2024

BlueRock Therapeutics receives FDA RMAT designation for Parkinson’s disease cell therapy candidate bemdaneprocel

Bemdaneprocel is the most clinically advanced investigational cell therapy in the U.S. for treating patients living with Parkinson’s disease


FDA grants priority review to Merck’s application for Keytruda plus chemotherapy for metastatic malignant pleural mesothelioma
Drug Approval | May 30, 2024

FDA grants priority review to Merck’s application for Keytruda plus chemotherapy for metastatic malignant pleural mesothelioma

Acceptance based on results demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients


Alembic Pharmaceuticals receives USFDA final approval for Sacubitril and Valsartan Tablets
Drug Approval | May 30, 2024

Alembic Pharmaceuticals receives USFDA final approval for Sacubitril and Valsartan Tablets

Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death


Strides receives USFDA approval for Sucralfate oral suspension, 1gm/10 mL
Drug Approval | May 29, 2024

Strides receives USFDA approval for Sucralfate oral suspension, 1gm/10 mL

Strides’ approval for this product marks the 1st Indian approval from the USFDA for this complex formulation


Heuron gets FDA green light for stroke triage and notification solution
News | May 25, 2024

Heuron gets FDA green light for stroke triage and notification solution

This marks the first FDA approval of an AI-based brain disorder analysis solution from Korea


Zydus receives final approval from USFDA for Theophylline ER Tablets
Drug Approval | May 25, 2024

Zydus receives final approval from USFDA for Theophylline ER Tablets

Theophylline is used to treat asthma and chronic obstructive pulmonary disease


Indica Labs receives FDA clearance for HALO AP Dx digital pathology platform
Digitisation | May 23, 2024

Indica Labs receives FDA clearance for HALO AP Dx digital pathology platform

For use with Hamamatsu Images acquired with the NanoZoomer S360MD slide scanner


Biocon Biologics’ receives FDA approval for Biosimilar Aflibercept for Yesafili
Drug Approval | May 21, 2024

Biocon Biologics’ receives FDA approval for Biosimilar Aflibercept for Yesafili

The approval of YESAFILI marks Biocon Biologics’ expansion into the ophthalmology therapeutic area in the United States