Browsing Tag
US Food and Drug Administration
333 posts
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…
Solara Pharma’s manufacturing site garners positive FDA review
Solara Active Pharma Sciences Ltd’s (Solara Pharma) manufacturing facility in Cuddalore has garnered approval from the US Food…
Balfaxar receives FDA nod for treating acquired coagulation factor deficiency
Octapharma USA has announced the US Food and Drug Administration (FDA)’s approval of Balfaxar (prothrombin complex concentrate, human-lans),…
Aurobindo Pharma subsidiary receives FDA approval for Plerixafor Injection
Eugia Pharma Specialities Limited, a fully-owned subsidiary of India-based Aurobindo Pharma Limited, has received final approval from the…