USFDA extends review period of GSK Momelotinib by three months Ruchika Sharma17 Jun 2023 10:00 AM ISTLondon: GSK plc has announced that the US Food and Drug Administration (FDA) has extended the review period of the new drug application (NDA) for...
Natco Pharma Vizag facility gets EIR from USFDA Ruchika Sharma16 Jun 2023 1:30 PM ISTHyderabad: Natco Pharma Limited has announced the successful closure of inspection and received Establishment Inspection Report (EIR) from the...
Laurus Labs gets USFDA EIR for Visakhapatnam facility Ruchika Sharma16 Jun 2023 12:30 PM ISTHyderabad: Laurus Labs has announced that the Company has received the Establishment Inspection Report (EIR) from the United States Food &...
Natco Pharma gets USFDA nod for Tipiracil Hydrochloride and Trifluridine Tablets Ruchika Sharma16 Jun 2023 11:39 AM ISTLonsurf is indicated primarily for the treatment of colorectal cancer.
USFDA issues 11 observations to Ipca Labs Ratlam facility Ruchika Sharma14 Jun 2023 1:30 PM ISTRatlam: Ipca Laboratories Limited has announced that the Company has received eleven observations from the United States Food and Drug Administration...
Zydus Lifesciences gets zero USFDA observations for Ahmedabad facility Ruchika Sharma14 Jun 2023 12:30 PM ISTAhmedabad: Zydus Lifesciences Ltd. has announced that the United States Food and Drug Administration (USFDA) has concluded...
USFDA nod to Granules India Seizure drug Levetiracetam Ruchika Sharma14 Jun 2023 11:43 AM ISTHyderabad: Granules India Limited today announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug...
USFDA approves Zydus Varenicline Tablets for smoking addiction treatment Ruchika Sharma13 Jun 2023 5:30 PM ISTAhmedabad: Zydus Lifesciences Limited has announced that the company has received final approval from the United States Food and Drug Administration ...
Zydus Lifesciences wins USFDA nod for Diclofenac Sodium and Misoprostol Delayed Release Tablets Ruchika Sharma13 Jun 2023 4:12 PM ISTDiclofenac Sodium and Misoprostol Delayed Release Tablets are used to treat osteoarthritis and rheumatoid arthritis in people at high risk for...
Granules India bags USFDA nod for Hypertension drug Metoprolol Succinate ER Ruchika Sharma13 Jun 2023 12:48 PM ISTMetoprolol Succinate ER Tablets are indicated for the treatment of hypertension in order to lower blood pressure.
USFDA grants priority review to Capivasertib in combination with Faslodex for advanced HR-positive breast cancer: AstraZeneca Ruchika Sharma13 Jun 2023 11:20 AM ISTBreast cancer is the most common cancer worldwide, with an estimated 2.3 million patients diagnosed each year.
USFDA nod to Caplin Steriles Cisatracurium Besylate Injection Ruchika Sharma12 Jun 2023 4:39 PM ISTChennai: Caplin Steriles Limited, a Subsidiary company of Caplin Point Laboratories Limited, has been granted final approval by the United States...
