FDA Approves Only Drug in U.S. to Treat Severe Malaria
Today, the U.S. Food and Drug Administration approved artesunate for injection to treat severe malaria in adult and pediatric patients. Treatment of severe malaria with intravenous (IV) artesunate should always be followed by a complete treatment course of an appropriate oral antimalarial regimen
Manufacturing | 27/05/2020 | By Darshana | 586
The department of Ayurveda, Yoga, Unani, Shiddha and Homoeopathy (Ayush) in collaboration with Council of Scientific and Industrial Research (CSIR) is working on developing four formulations of traditional medicine to treat the novel coronavirus infections and accordingly clinical trials are also being planned within next one week
Manufacturing | 19/05/2020 | By Darshana | 355
Cipla Limited has signed a non-exclusive licensing agreement with Gilead Sciences, Inc. for the manufacturing and distribution of the investigational medicine remdesivir, which has been issued an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) to treat COVID-19 patients
Manufacturing | 13/05/2020 | By Darshana | 265
Abbott announces CE mark approval for its COVID-19 laboratory based antibody test in India
Abbott announced that it received CE Mark to the IVD Directive (98/79/EC) for its laboratory-based serology blood test for the detection of the antibody, IgG, that identifies if a person has had the novel coronavirus (COVID-19)
Manufacturing | 05/05/2020 | By Darshana | 380
Roche's COVID-19 antibody test receives FDA Emergency Use Authorization and is available in markets
Roche has already started shipping the new antibody test to leading laboratories globally and will ramp up production capacity to high double-digit millions per month to serve healthcare systems in countries accepting the CE mark2 as well as the U.S.
Manufacturing | 04/05/2020 | By Darshana | 457
Sanofi & GSK ink collaboration to develop unprecedented vaccine for COVID-19
Sanofi and GSK announced that they have signed a letter of intent to develop an adjuvanted vaccine for COVID-19, using innovative technology from both companies, to help address the ongoing pandemic
Manufacturing | 16/04/2020 | By Darshana | 372
ICMR approves Molbio Diagnostics' testing kit for COVID-19
Molbio Diagnostics supported by India Health Fund, through the Centre for Health Research and Innovations (CHRI), has recently obtained approval from Indian Council of Medical Research (ICMR) for its testing kit -- the Truenat Beta CoV test -- to be used by patients to test for COVID-19
Manufacturing | 07/04/2020 | By Darshana | 395
Lincoln Pharma continues to invest in upgrading manufacturing capacity
Lincoln Pharmaceuticals Ltd continues to invest in upgrading manufacturing capacity, new product development and expand global footprints
Manufacturing | 06/04/2020 | By Darshana | 352
Lupin's Aurangabad Facility Receives EIR from U.S. FDA
Pharma major Lupin Limited (Lupin) today announced the receipt of the Establishment Inspection Report (EIR) from the U.S. FDA for its Aurangabad, India facility. The inspection for the facility was carried out by the U.S. FDA between February 10, 2020 and February 14, 2020 and concluded with no observations
Manufacturing | 03/04/2020 | By Darshana | 1448
COVID-19 Testing Kits: Mylab Signs Deal With Serum
Mylab Discovery Solutions, the first Indian company whose testing kit was approved by the Indian Council of Medical Research (ICMR), has tied up with Serum Institute of India, world's largest vaccine manufacturer by number of doses produced, to scale up the operations and escalate faster delivery of testing kits
Manufacturing | 02/04/2020 | By Darshana | 660
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