The Pharma Data

JANUARY 6, 2021

He continues: “With the green light granted by the FDA to continue our clinical research, we are one step closer to offering psoriasis patients a novel, improved oral treatment option and thereby enhancing their quality of life. The following files are available for download: View original content: [link]. Source link.

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FDA Approval FDA Clinical Development Clinical Research 52

The Pharma Data

DECEMBER 16, 2020

OS is a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. View original content to download multimedia: [link]. and 2 trials planned by our sublicensee WPD in Poland.

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FDA Approval FDA Pharmaceuticals Clinical Trials 52

The Pharma Data

OCTOBER 25, 2020

FDA that Emergency Use Authorization (EUA) submission is acceptable for all three COVID diagnostic tests. SQI is accelerating the clinical development of its direct-to-consumer COVID-19 HOME Antibody Test, its COVID-19 RALI-dx Severity Triage Test and its COVID-19 RALI- fast Severity Triage Point-of-Care (POC) Test.

FDA 52

FDA Hospitals Clinical Development FDA Approval 52

The Pharma Data

JANUARY 17, 2021

As a result, there is a high unmet need for an FDA approved local injection therapy that is safe and effective. Members of the senior management team have a combined experience in the biopharmaceutical industry, spanning clinical development, regulatory, financial and business management in both the USA and China.

Treatment 52

Treatment Trials FDA Approval RNA 52

The Pharma Data

JANUARY 31, 2021

These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.” Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. View original content to download multimedia: [link]. SOURCE Clover Biopharmaceuticals.

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Clinical Trials Vaccine Trials Virus 52

The Pharma Data

JANUARY 13, 2021

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. A preprint supporting Brilacidin’s COVID-19 treatment potential can be downloaded at the link below.

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52

The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

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FDA Approval FDA Treatment Clinical Trials 40