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FDA Approvals

US FDA Approves Jascayd for Idiopathic Pulmonary Fibrosis

Americas
The U.S. Food and Drug Administration (FDA) has approved Jascayd (nerandomilast) tablets to treat idiopathic pulmonary fibrosis (IPF), a rare and serious lung disease....

FDA Clears Tissue Repair Drug AD-NP1 For Clinical Trials

Americas
The FDA has granted approval to begin clinical trials of the AD-NP1 drug. It is a first-in-class drug for tissue regeneration, which targets cellular...

US FDA Launches Fast-Track Review Scheme for Generic Drugs

Americas
The FDA has introduced a pilot fast-track review programme aimed at accelerating reviews for generic medicines tested and manufactured within the United States, marking...

US FDA Approves Breast Cancer Therapy Inluriyo by Eli Lilly

Clinical Trials
Eli Lilly and Company has received U.S. Food and Drug Administration (FDA) approval for Inluriyo (imlunestrant, 200 mg tablets), an oral estrogen receptor antagonist....

US FDA to Approve Leucovorin for Cerebral Folate Deficiency

Drug Development
The U.S. Food and Drug Administration (FDA) has started the process to approve leucovorin calcium tablets as a treatment for patients with cerebral folate...

FDA Grant Approval for Opzelura Cream for Pediatric Eczema

Drug Development
The U.S. Food and Drug Administration has granted approval to Incyte’s eczema cream, Opzelura, for use in children aged 2 to 11 years, the...

Amneal Secures FDA Approval for Sodium Oxybate Oral Solution

Drug Development
Amneal Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted approval for the company’s sodium oxybate oral solution 500...

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White Papers

The Future of Digital Health

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The pharmaceutical industry is acutely aware that the future of health and care, particularly in the United States, are trending toward a digital revolution....

Five Best Practices to Deliver Exceptional Multichannel Experiences

Whitepapers 0
A one-size-fits-all customer journey no longer works. In the age of the consumer, the quality of the interaction is paramount. In this paper, we...

The Impact and Use of Social Media in Pharmacovigilance

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Social media presents new channels and methods for biopharmaceutical companies to move away from traditional pharmacovigilance (PV) systems and safety reporting methods towards more...

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