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Results For "United-States"

842 News Found

Strides receives USFDA approval for Ibuprofen Oral Suspension
Drug Approval | May 30, 2022

Strides receives USFDA approval for Ibuprofen Oral Suspension

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Motrin Oral Suspension, 100 mg/5 mL, of McNeil Consumer Healthcare (McNeil)


OS-SiA digital pathology scanner developed by OptraSCAN granted US patent
Biotech | May 30, 2022

OS-SiA digital pathology scanner developed by OptraSCAN granted US patent

OS-SiA is the industry’s first AI-enabled digital scanner that will provide real-time predictive analysis and actionable insights


Zydus receives EIR from USFDA for its injectables manufacturing facility at Jarod
Biotech | May 29, 2022

Zydus receives EIR from USFDA for its injectables manufacturing facility at Jarod

The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs


CorePath partners with Cizzle Bio to develop blood test to detect lung cancer
Biotech | May 27, 2022

CorePath partners with Cizzle Bio to develop blood test to detect lung cancer

Lung cancer is the leading cause of cancer death in the USA, making up almost 25% of all cancer deaths


Zydus Lifesciences receives final approval from USFDA for Pemetrexed for Injection
Drug Approval | May 26, 2022

Zydus Lifesciences receives final approval from USFDA for Pemetrexed for Injection

Pemetrexed for Injection has a market size of USD 1,236 mn (as per IQVIA MAT March’22)


European Commission approves Keytruda plus chemotherapy as neoadjuvant treatment for breast cancer
Drug Approval | May 25, 2022

European Commission approves Keytruda plus chemotherapy as neoadjuvant treatment for breast cancer

This Keytruda combination is the first immunotherapy option approved in the EU for high-risk early-stage TNBC


Sputnik V demonstrates strong protection against Omicron variant
Biotech | May 25, 2022

Sputnik V demonstrates strong protection against Omicron variant

The study was conducted in equal laboratory conditions in the Spallanzani Institute in Italy on comparable sera samples from individuals vaccinated with Sputnik V and Pfizer with a similar level of IgG antibodies and virus-neutralizing activity (VNA) against Wuhan variant.


Soligenix receives US patent allowance for its thermostabilized vaccine platform
Biotech | May 23, 2022

Soligenix receives US patent allowance for its thermostabilized vaccine platform

Includes thermostabilized Ebola vaccines


USFDA approves Dupixent as first treatment for 12 and older with eosinophilic esophagitis
Drug Approval | May 21, 2022

USFDA approves Dupixent as first treatment for 12 and older with eosinophilic esophagitis

Dupixent is the first and only medicine indicated to treat eosinophilic esophagitis in the United States; approval granted more than two months ahead of USFDA’s Priority Review action date


Glenmark receives sANDA approval for Abiraterone Acetate tablets
Drug Approval | May 20, 2022

Glenmark receives sANDA approval for Abiraterone Acetate tablets

According to IQVIA sales data for the 12-month period ending March 2022, the Zytiga tablets, 500 mg market achieved annual sales of approximately US $ 260.2 million