Tag: US Food and Drug Administration
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 AstraZeneca’s Truqap (capivasertib) in combination with Faslodex ... Read More
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 Virus prefusion F (RSVpreF) vaccine. This cutting-edge ... Read More
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 (FDA) nod for its Abbreviated New Drug ... Read More
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 nod under the PEPFAR program for its ... Read More
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 Metformin Hydrochloride Extended-Release Tablets. This launch introduces ... Read More
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 and Drug Administration (US FDA) for its ... Read More
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 and Drug Administration (US FDA). Following an ... Read More
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), a treatment for urgent reversal of acquired ... Read More
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 US Food and Drug Administration (FDA). This ... Read More
FDA grants tentative approval to Lupin for Dolutegravir, Lamivudine, and Tenofovir Alafenamide Tablets
Lupin Limited, a leading global pharmaceutical company, has received tentative approval for its New Drug Application (NDA) for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets from ... Read More
