Tag: US Food and Drug Administration

FDA approves AstraZeneca’s Truqap for advanced breast cancer treatment

businessnewstoday- November 20, 2023

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

businessnewstoday- August 23, 2023

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

businessnewstoday- August 22, 2023

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

businessnewstoday- August 16, 2023

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

businessnewstoday- August 13, 2023

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

businessnewstoday- August 9, 2023

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

businessnewstoday- August 7, 2023

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

businessnewstoday- July 26, 2023

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

businessnewstoday- July 25, 2023

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

businessnewstoday- July 21, 2023

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