Browsing Tag
US Food and Drug Administration
336 posts
Primary IgA nephropathy : FDA grants full approval to Travere Therapeutics’ Filspari
In a groundbreaking move, the US Food and Drug Administration (FDA) has granted full approval to Travere Therapeutics’…
Granules India faces six observations after US FDA inspection at Gagillapur facility in Hyderabad
Granules India Limited has recently completed a US Food and Drug Administration (US FDA) inspection at its Gagillapur…
FDA approval for Zurnai Auto-Injector: A new weapon in the fight against opioid overdose
In a major development in the battle against the opioid epidemic, Purdue Pharma’s Zurnai Auto-Injector has been granted…
Game-changer for kidney disease: Novartis’ Fabhalta wins FDA approval in record time
Novartis has reached a pivotal moment in the treatment of rare kidney diseases with the US Food and…
FDA approves AstraZeneca’s Truqap for advanced breast cancer treatment
In a notable development in the field of oncology, the US Food and Drug Administration (FDA) has approved…
FDA greenlights Pfizer’s ABRYSVO vaccine for shielding infants from RSV
The US Food and Drug Administration (FDA) has granted approval to Pfizer Inc.’s ABRYSVO, a bivalent Respiratory Syncytial…
Marksans Pharma bags FDA approval for Mucinex bioequivalent tablets
Indian pharmaceutical powerhouse, Marksans Pharma has achieved a significant milestone, securing the coveted US Food and Drug Administration…
Aurobindo Pharma gets tentative FDA approval for generic HIV treatment for children
Aurobindo Pharma Limited has achieved a significant milestone by securing the US Food and Drug Administration (FDA)’s tentative…
Dr. Reddy’s Laboratories debuts generic version of KOMBIGLYZE XR in US
In a significant development for diabetes treatment in the U.S., Dr. Reddy’s Laboratories has unveiled its Saxagliptin and…
Lupin subsidiary gets FDA approval for Fluocinolone Acetonide Oil
Lupin Limited said that their wholly-owned US subsidiary, Novel Laboratories Inc., has secured approval from the US Food…