Neuren Pharmaceuticals advances NNZ-2591 for Phelan-McDermid syndrome to Phase 3 clinical trial
Neuren Pharmaceuticals has secured approval from the United States Food and Drug Administration (FDA) to progress into the first-ever pivotal Phase 3 clinical trial of ... Read More
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' Filspari (sparsentan) for treating primary IgA nephropathy ... Read More
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 facility in Hyderabad, Telangana, resulting in six ... Read More
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 approval by the US Food and Drug ... Read More
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 Drug Administration (FDA) granting accelerated approval for ... Read More
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