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Volume 16 Issue 3
 
 
Regional News

Pfizer’s tick-borne encephalitis vaccine TicoVac passes FDA muster, allowing travelers and the military easier access

Pfizer's vaccines group has been on a roll, generating world-leading COVID-19 shot sales and scoring a June approval for a much-anticipated Prevnar 13 follow up. Late...
18 August 2021 Regional News CDC | FDA
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Regional News

After FibroGen’s FDA rejection in anemia, Akebia CEO aims to seize first-in-class opening with vadadustat

In the race for novel oral drugs to treat anemia of chronic kidney disease, AstraZeneca and FibroGen’s roxadustat held the front-runner position for quite some time. ...
18 August 2021 Regional News Akebia | FDA
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Volume 13 Issue 4

Virtual Town Halls Provide Timely Support to SARS-CoV-2 Test Developers

Since the onset of the COVID-19 public health emergency, the US Food and Drug Administration (FDA) has hosted a weekly “virtual town hall” meeting to provide the oppo...
9 August 2021 Volume 13 Issue 4 COVID-19 | FDA
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Volume 13 Issue 4

Critical Considerations for Clinical Trial Safety Reporting Investments

Naturally, safety event reporting and pharmacovigilance (PV) should be subject to detailed regulatory scrutiny as evidenced by the Food and Drug Administration (FDA) ...
9 August 2021 Volume 13 Issue 4 adverse events | clinical trial
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Regional News

Merck’s Keytruda scores first-in-class nod in early triple-negative breast cancer despite FDA’s prior reluctance

The FDA had reservations about Merck & Co.’s proposed use of Keytruda around surgery for patients with early triple-negative breast cancer. But less than three mo...
4 August 2021 Regional News breast cancer | clinical trial
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Regional News

Lawmakers press FDA for answers about its plans to restart foreign inspections

FDA inspections restarted earlier this month in the United States, finally giving the regulator a chance to work through the enormous domestic backlog which accumulat...
4 August 2021 Regional News clinical trials | COVID-19
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Europe

FDA finalizes guidance on integrating EHRs into clinical trials

The FDA recently finalized an eagerly awaited guidance on the incorporation of electronic health records and real-world data into clinical trials and product submissi...
31 July 2018 Europe | North America clinical | EHRs
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Europe

Orchard Therapeutics’ OTL-200 Receives Rare Pediatric Disease Designation from FDA for Treatment of Metachromatic Leukodystrophy Orchard’s fourth Rare Pediatric Disease Designation for autologous ex vivo gene therapy.

Orchard Therapeutics, a leading commercial stage company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies, today a...
9 May 2018 Europe designation | FDA
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Europe

Enrollment on Tazemetostat Clinical Trials Halted by the FDA

Robert Bazemore Enrollment has been halted by the FDA on clinical trials of tazemetostat in patients with var...
25 April 2018 Europe | North America clinical | enrollment
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Asia Pacific

Ultragenyx and Kyowa Kirin Announce FDA Approval of Crysvita® (burosumab-twza) for the Treatment of Children and Adults with X–Linked Hypophosphatemia (XLH)

First Approved Therapy for XLH in the U.S.; Only Treatment that Targets the Underlying Cause of this Rare, Hereditary, Lifelong Disease Ultragenyx to Host Conference ...
18 April 2018 Asia Pacific | Europe | North America approval | Crysvita
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