Springworks shares fall despite drug trial's success
Bio Pharma Dive
MAY 24, 2022
The biotech plans to seek FDA approval for its soft-tissue tumor treatment after positive study results. But investors still sent the stock down by nearly 10%.
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FDA Approvals for a Liquid Epilepsy Drug and Vitiligo Medication – Xtalks Life Science Podcast Ep. 71
XTalks
AUGUST 3, 2022
In this episode, Ayesha discussed the FDA approval of Azurity Pharmaceutical’s Zonisade (zonisamide oral suspension) as an adjunct therapy for the treatment of seizures in adults and pediatric patients 16 years of age and older with epilepsy. The drug is the first FDA approved oral suspension form of zonisamide.
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Reimagining Clinical Trials: Why are Virtual Clinical Trials Becoming the New Normal?
Delveinsight
AUGUST 13, 2021
Clinical trials are an essential part of the drug development process. Worldwide, more than 2 million clinical trials are registered and the number is steadily increasing over the past several years. The conduct of trials was not possible due to the risk of catching coronavirus. Why the Need?
An Evolving Regulatory Environment for Rare and Orphan Diseases
Advarra
AUGUST 16, 2022
Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Before 1983, only 38 orphan drugs had received U.S. Food and Drug Administration (FDA) approval.
Broadening Your Pharma Network on LinkedIn
Pharma Marketing Network
OCTOBER 23, 2024
Whether you’re looking to promote a new drug brand or stay updated on trending healthcare innovations , having a broad network is key. Incorporate SEO-friendly keywords like pharma marketing , drug commercialization , and healthcare innovations. Isn’t it just a platform for recruiters and job seekers? First impressions matter.
FDA Cracks Down on ClinicalTrials.gov Reporting Failures
FDA Law Blog
MAY 3, 2021
for failure to submit the required information following completion of a clinical trial evaluating the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (see FDA press release announcing the Notice of Noncompliance here ). 42 C.F.R. §§ 11.10, 11.44(a).
FDA Cracks Down on ClinicalTrials.gov Reporting Failures
FDA Law Blog
MAY 3, 2021
for failure to submit the required information following completion of a clinical trial evaluating the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma (see FDA press release announcing the Notice of Noncompliance here ). 42 C.F.R. §§ 11.10, 11.44(a).
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