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Results For "Food-and-Drug-Administration"

1074 News Found

Marinus expands enrollment criteria to support recruitment in Phase 3 RAISE Trial in refractory status epilepticus
Diagnostic Center | June 10, 2022

Marinus expands enrollment criteria to support recruitment in Phase 3 RAISE Trial in refractory status epilepticus

Marinus has broadened inclusion criteria in the RAISE trial to allow for enrollment of patients previously treated with IV anesthesia.


Sanofi Dupixent gets USFDA nod for atopic dermatitis
Drug Approval | June 10, 2022

Sanofi Dupixent gets USFDA nod for atopic dermatitis

Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy to adulthood


Sumitomo Pharma Oncology receives orphan drug designation for the treatment of myelofibrosis
Drug Approval | June 09, 2022

Sumitomo Pharma Oncology receives orphan drug designation for the treatment of myelofibrosis

TP-3654 is currently being evaluated in a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with intermediate or high-risk primary or secondary myelofibrosis.


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