Dr Reddy's Labs unveils cancer drug Lenalidomide in US Ruchika Sharma8 Sept 2022 2:47 PM ISTDr. Reddy's Lenalidomide Capsules are available in strengths of 2.5 mg, 5 mg, and 10 mg, each in a bottle-count size of 28, as well as 15 mg, 20 mg,...
Pfizer secures USFDA Breakthrough Therapy designation for Group B Streptococcus Vaccine Ruchika Sharma8 Sept 2022 1:00 PM ISTGroup B Streptococcus (GBS) is a common bacterium that can cause potentially devastating diseases in infants, including sepsis, pneumonia and...
Cipla Cancer drug Lenalidomide bags USFDA okay Ruchika Sharma7 Sept 2022 4:22 PM ISTMumbai: Drugmaker, Cipla Limited, today announced that the company has received final approval for its Abbreviated New Drug Application (ANDA) for...
Philips recalls some masks used with respiratory devices over safety issues Ruchika Sharma7 Sept 2022 9:00 AM ISTThe health regulator said it was monitoring the situation and working with Philips in relation to the recalled devices.
AstraZeneca gets USFDA nod for Imfinzi plus chemotherapy to treat advanced biliary tract cancer Ruchika Sharma5 Sept 2022 1:30 PM ISTBiliary tract cancer is a group of rare and aggressive cancers that occur in the bile ducts and gallbladder.
Lupin, Zydus Lifesciences recall products in US over manufacturing issues Ruchika Sharma3 Sept 2022 12:03 PM ISTNew Delhi: Home-grown drug makers Zydus Lifesciences and Lupin are recalling products in the US, the world's largest market for medicines, due to...
Boehringer Ingelheim gets USFDA nod for SPEVIGO to treat generalized pustular psoriasis flares Ruchika Sharma3 Sept 2022 11:00 AM ISTRidgefield: Boehringer Ingelheim has announced that the U.S. Food and Drug Administration (USFDA) has approved SPEVIGO, the first approved treatment...
Sanofi gets USFDA nod for ASMD drug Xenpozyme Ruchika Sharma2 Sept 2022 3:57 PM ISTASMD, historically known as Niemann-Pick disease types A, A/B, and B, is an extremely rare, progressive genetic disease with significant morbidity and...
Pfizer-BioNTech gets USFDA emergency use nod for Omicron BA.4/BA.5-Adapted Bivalent COVID vaccine booster for 12 years and older Ruchika Sharma2 Sept 2022 2:00 PM ISTThe Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer.
Biocon arm gets multiple USFDA observations across India, Malaysia Ruchika Sharma1 Sept 2022 5:00 PM ISTBiocon said the inspections were on account of three pre-approval inspections for biosimilar Bevacizumab, rh-Insulin and Insulin Aspart and a capacity...
USFDA issues 2 observations for Alembic Pharma Karkhadi facility Ruchika Sharma1 Sept 2022 3:08 PM ISTNew Delhi: Drugmaker, Alembic Pharma, today announced that the United States Food and Drug Administration (USFDA) has issued a Form 483 with...
Strides Pharma arm gets EIR from USFDA for Bengaluru facility Ruchika Sharma1 Sept 2022 12:30 PM ISTThe Unit 2 facility has high-end automated DP lines integrated with isolators to convert drug substances (DS) into stable formulations and fill finish...
