AstraZeneca, Merck get Chinese nod for Lynparza to treat ovarian cancer Ruchika Sharma24 Sept 2022 3:24 PM ISTIn China, Lynparza is approved for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer as well as a 1st-line maintenance...
Need to fast-track regulatory processes for biotech sector: CII Report Ruchika Sharma24 Sept 2022 12:15 PM IST"There is a need for autonomy in policy making and implementation," the report released on Friday at the 4th CII Lifesciences Conclave stated.
Cipla gets USFDA EIR for Indore facility Ruchika Sharma24 Sept 2022 11:07 AM ISTMumbai: Pharma major, Cipla, has recently announced that the Company has received Establishment Inspection Report (EIR) from the United States Food...
Govt approves setting up of Exports Promotion Council for Medical Devices Ruchika Sharma23 Sept 2022 5:00 PM ISTThe new Export Promotion Council (EPC) for medical devices will be set up, with Headquarters in YEIDA, Greater Noida, Uttar Pradesh, and regional...
USFDA nod to Eli Lilly RET Inhibitor Retevmo for adults with advanced or metastatic solid tumors with a RET Gene Fusion, regardless of type Ruchika Sharma23 Sept 2022 4:20 PM ISTIn addition to the tumor-agnostic approval, the USFDA has granted traditional approval for Retevmo in adult patients with locally advanced or...
Aurobindo Pharma US arm gets USFDA EIR for Raleigh facility Ruchika Sharma23 Sept 2022 2:32 PM ISTHyderabad: Aurobindo Pharma has recently announced that Aurolife Pharma LLC, a wholly owned step-down subsidiary of the Company has received an...
Shilpa Medicare Hyderabad division gets USFDA clearance Ruchika Sharma23 Sept 2022 12:15 PM ISTThe USFDA clearance on the facility will enable the company to test and release batches into the US from this facility.
Lupin bags USFDA nod for Diclofenac Sodium Topical Solution to treat arthritic knee pain Ruchika Sharma23 Sept 2022 11:15 AM ISTThe product will be manufactured at Lupin's facility in Pithampur, India.
COVID-19 Treatment: GSK Sotrovimab, Roche antibody cocktail casirivimab-imdevimab no longer recommended by WHO Ruchika Sharma22 Sept 2022 4:14 PM ISTBoth therapies continue to be recommended for use by the European drugs regulator.
Novartis to take US drug patent case to Supreme Court Ruchika Sharma22 Sept 2022 3:46 PM ISTZurich: Novartis AG plans to ask the U.S. Supreme court to uphold the validity of a patent it holds on the dosing regimen for multiple sclerosis drug...
Shilpa Medicare bags CDSCO nod for topical hemostatic spray of Tranexamic Acid Ruchika Sharma22 Sept 2022 2:59 PM ISTThe product is protected by granted patents in India till 2037 and in US, Australia, Russia and South Africa till 2038.
AstraZeneca Severe Asthma treatment Tezspire gets nod in EU Ruchika Sharma22 Sept 2022 2:00 PM ISTTezspire (tezepelumab) is being developed by AstraZeneca in collaboration with Amgen.
