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Results For "U.S.-FDA"

246 News Found

U.S. FDA approves ANI’s purified cortrophin gel
Biotech | November 03, 2021

U.S. FDA approves ANI’s purified cortrophin gel

Cortrophin gel is purified corticotropin (ACTH), an important treatment option for patients struggling with certain chronic autoimmune disorders. It acquired the NDA for cortrophin gel from Merck & Co. in 2016


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


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


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.


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


Merck and Ridgeback seek EUA from U.S. FDA for molnupiravir
News | October 11, 2021

Merck and Ridgeback seek EUA from U.S. FDA for molnupiravir

If authorized, molnupiravir could be the first oral antiviral medicine for the treatment of Covid-19