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Results For "USFDA"

1451 News Found

Suven Pharmaceuticals acquires Casper Pharma for Rs 155 crore
News | April 05, 2022

Suven Pharmaceuticals acquires Casper Pharma for Rs 155 crore

Casper Pharma is a Hyderabad based SEZ company engaged in the formulations business. Post-purchase of shares, the target entity would become a wholly-owned subsidiary of SPL


CerroZone reduces airborne Covid-19 Delta variant by 99.998% in 1.2 seconds
Biotech | March 31, 2022

CerroZone reduces airborne Covid-19 Delta variant by 99.998% in 1.2 seconds

Air purification system achieves Intertek zero ozone certification


ASC Therapeutics gets green light to advance gene therapy for Hemophilia A
Biotech | March 30, 2022

ASC Therapeutics gets green light to advance gene therapy for Hemophilia A

A novel second-generation approach to achieve a safe, durable, and stable transgene expression to overcome the challenges of factor VIII replacement therapies


Ozempic 2.0 mg approved in the US for the treatment of type 2 diabetes
Drug Approval | March 29, 2022

Ozempic 2.0 mg approved in the US for the treatment of type 2 diabetes

Ozempic is now approved in the US at 0.5 mg,1.0 mg and 2.0 mg doses for the treatment of type 2 diabetes in adults


Novavax to participate in two booster studies using its COVID-19 vaccine
Biotech | March 26, 2022

Novavax to participate in two booster studies using its COVID-19 vaccine

U.S. NIAID-sponsored trial will evaluate heterologous booster regimens, including NVX-CoV2373, after primary series with current USFDA approved or emergency use authorized-vaccines


Merck’s Keytruda approved for fourth gynecologic cancer indication
Drug Approval | March 22, 2022

Merck’s Keytruda approved for fourth gynecologic cancer indication

The approval is based on new data from cohorts D and K of the KEYNOTE-158 trial


Glenmark receives ANDA approval for Lacosamide tablets
Drug Approval | March 21, 2022

Glenmark receives ANDA approval for Lacosamide tablets

The company plans to launch the product immediately


Zydus receives PAS approval for Mycophenolate Mofetil
Drug Approval | March 21, 2022

Zydus receives PAS approval for Mycophenolate Mofetil

The drug is indicated for use in combination with other drugs


Wockhardt’s novel antibiotic Phase 1 trial to be conducted by NIH, USA
Biotech | March 16, 2022

Wockhardt’s novel antibiotic Phase 1 trial to be conducted by NIH, USA

The USFDA has granted a qualified infectious disease product (QIDP) designation to WCK 6777, which signifies its ability to meet unmet medical needs and facilitates a faster approval process


Unichem receives ANDA approval for hypertension drug
Drug Approval | March 16, 2022

Unichem receives ANDA approval for hypertension drug

Nebivolol is used alone or together with other medicines to treat high blood pressure