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Results For "Food-and-Drug-Administration"

1021 News Found

Halozyme announces commercial launch of testosterone undecanoate 'TLANDO'
News | June 08, 2022

Halozyme announces commercial launch of testosterone undecanoate 'TLANDO'

TLANDO was approved by the U.S. Food and Drug Administration (FDA) on March 28, 2022.


Novartis Tafinlar and Mekinist demonstrates unprecedented efficacy in pediatric patients
News | June 08, 2022

Novartis Tafinlar and Mekinist demonstrates unprecedented efficacy in pediatric patients

If approved, Tafinlar + Mekinist may offer a potential new standard-of-care for pediatric patients with this brain cancer


Lupin receives tentative approval from FDA for Ivacaftor tablets
Drug Approval | June 08, 2022

Lupin receives tentative approval from FDA for Ivacaftor tablets

Ivacaftor Tablets had estimated annual sales of USD 109 million in the US.


Zydus Lifesciences receives USFDA approval for Adapalene and Benzoyl Peroxide Topical Gel
Drug Approval | June 07, 2022

Zydus Lifesciences receives USFDA approval for Adapalene and Benzoyl Peroxide Topical Gel

The drug will be manufactured at the group’s topical facility at Ahmedabad


APhA appoints Ilisa Bernstein Interim CEO
People | June 06, 2022

APhA appoints Ilisa Bernstein Interim CEO

Dr. Bernstein will tap into her decades of leadership and strategy experience as she transitions into this new role at APhA


Mitsubishi Tanabe Pharma America presents 48-week results from phase 3 safety clinical study of Radicava ORS
News | June 03, 2022

Mitsubishi Tanabe Pharma America presents 48-week results from phase 3 safety clinical study of Radicava ORS

Radicava ORS was approved by the U.S. Food and Drug Administration (FDA) on May 12, 2022


GSK to acquire clinical-stage biopharmaceutical company Affinivax for US$ 3.3 billion
News | June 03, 2022

GSK to acquire clinical-stage biopharmaceutical company Affinivax for US$ 3.3 billion

GSK to pay $2.1 billion upfront and up to $1.2 billion in potential development milestones


USFDA accepts dupilumab for priority review in adults with prurigo nodularis
Drug Approval | June 01, 2022

USFDA accepts dupilumab for priority review in adults with prurigo nodularis

Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approved


FDA approves Roche’s Evrysdi for use in babies under two months with SMA
Drug Approval | June 01, 2022

FDA approves Roche’s Evrysdi for use in babies under two months with SMA

Evrysdi has proven efficacy in babies, children and adults with more than 5,000 patients treated to date


US FDA accepts new drug application filed by Avillion for AstraZeneca's PT027
Drug Approval | June 01, 2022

US FDA accepts new drug application filed by Avillion for AstraZeneca's PT027

Avillion announces expansion of partnership with AstraZeneca on PT027 and will fund and execute a new Phase 3b study