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Results For "FDA"

2067 News Found

Novartis receives priority review by U.S. FDA and filing acceptance by EMA for Kymriah
Biotech | October 28, 2021

Novartis receives priority review by U.S. FDA and filing acceptance by EMA for Kymriah

Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications


Ocugen submits IND application with U.S. FDA for Covaxin phase 3 trial
Biotech | October 28, 2021

Ocugen submits IND application with U.S. FDA for Covaxin phase 3 trial

The Phase 3 study is designed to bridge data collected from the vaccine efficacy trial conducted in India to the U.S. population


U.S. FDA expands approval of Dupixent to include children aged 6 to 11 years
Drug Approval | October 22, 2021

U.S. FDA expands approval of Dupixent to include children aged 6 to 11 years

Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial, supporting potential as a best-in-class option


U.S. FDA gives green light to Moderna and J&J booster doses
Drug Approval | October 21, 2021

U.S. FDA gives green light to Moderna and J&J booster doses

The authority also allowed mix and match of booster doses once the primary vaccine has been administered.


FDA approves Cyltezo, the first interchangeable biosimilar to Humira
Drug Approval | October 20, 2021

FDA approves Cyltezo, the first interchangeable biosimilar to Humira

Second interchangeable biosimilar product approved by agency


U.S. FDA authorises new saliva sample collection for Covid-19
Medical Device | October 19, 2021

U.S. FDA authorises new saliva sample collection for Covid-19

The Amplitude Solution gives laboratories the ability to scale Covid-19 PCR testing and process up to 8,000 samples a day


Dr Reddy’s Labs announces U.S. FDA approval for Lenalidomide capsules
Drug Approval | October 19, 2021

Dr Reddy’s Labs announces U.S. FDA approval for Lenalidomide capsules

The company is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg


U.S. FDA advisory committee recommends J&J booster dose
Biotech | October 18, 2021

U.S. FDA advisory committee recommends J&J booster dose

U.S. FDA to decide whether to authorize a booster dose in the coming days


U.S. FDA approves Roche’s Tecentriq as adjuvant treatment for small cell lung cancer
Drug Approval | October 18, 2021

U.S. FDA approves Roche’s Tecentriq as adjuvant treatment for small cell lung cancer

Tecentriq is the first and only cancer immunotherapy approved for NSCLC in the adjuvant setting


IOL receives Korean FDA approval
Drug Approval | October 14, 2021

IOL receives Korean FDA approval

The company’s pharmaceutical API products Ibuprofen and fenofibrate got the go-ahead