Latest News for: Executive nda


DURECT Completes Enrollment in Phase 2b AHFIRM Trial of Larsucosterol in Alcohol-Associated Hepatitis

Victoria Advocate 07 Jun 2023
Brown, D.V.M., President and Chief Executive Officer of DURECT. "We are preparing to file a New Drug Application (NDA) for larsucosterol in AH pending a positive AHFIRM trial outcome and Food and Drug Administration (FDA) guidance, and hope to expedite regulatory discussions ...

NDA develops Medium Term Development Strategy

Business Ghana 23 May 2023
Sulley Sambian, the Chief Executive Officer of the NDA, in a statement, said the MTDS were designed to achieve the greatest possible impact for the people and communities in the NSEZ with a special focus on poverty reduction, job creation, and sustainable production systems.

Northen Development Authority awards 126 projects in Upper West Region

Ghana Business News 22 May 2023
Sulley Sambian, Chief Executive Officer of the NDA announced during his maiden tour of the region to inaugurate some of the projects ... The NDA Chief Executive Officer also commissioned a rural electrification project for the residents of Kaleo-Booduori in the Nadowli –Kaleo ...

NDA engages stakeholders on 5-year development strategy

Business Ghana 21 May 2023
The Northern Development Authority (NDA) has held separate ... The Chief Executive Officer of the NDA, Sulley Sambian, lauded the stakeholders for their contributions towards the development of the five-year development strategy and appealed to them to support its implementation.

BJP executive committee adopts resolution complimenting Centre for sanctioning ₹1,250 crore additional fund to U.T.

The Hindu 20 May 2023
The State executive committee passes resolution praising NDA governments at the Centre and the U.T. The meeting also deliberated on the preparations for the Lok Sabha polls from the lone seat in the Union Territory ....

New Drug Approvals and Their Contract Manufacture: 2023 Report - Detailed view of CDMO Performance ...

Eagle-Tribune 19 May 2023
Key Topics Covered.Executive SummaryPlayersTechnology BriefingInnovative drug approvalsDose outsourcing of drug approvalsTrendsIndustry AnalysisIntroductionFDA NDA approvals overviewMore biologic NME approvals than small molecule equivalentsCell and gene ...

In Advance of Hearing, Tiger Woods's NDA With Erica Herman Revealed Along With Emails

The Post and Courier 09 May 2023
The case between Herman and Woods centers around a Non-Disclosure and Acknowledgement Agreement that was purported to be executed by both Herman and Woods on Aug ... 7, Herman emailed Hubman about the NDA. ... Woods's legal team also argues that the NDA was executed properly, and that Herman agreed to arbitrate disputes with Woods.

Tiger Woods Apparently Had a Good Day in Court in Dispute With Ex-Girlfriend

The Post and Courier 09 May 2023
The agreement that Judge Metzger was referring to is a Non-Disclosure and Acknowledgement Agreement that was purported to be executed by both Herman and Woods on Aug ... McNamara, executive vice president of ETW Corporation, all in some way supporting that the NDA is valid and the signatures are authentic.

Veru Reaches Agreement with FDA on Confirmatory Phase 3 Clinical Trial for Sabizabulin ...

Eagle-Tribune 04 May 2023
... full approval and obtaining regulatory clarity on the design of our confirmatory Phase 3 clinical study and a path forward for a new EUA and/or NDA submission is the important first step,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru.

Day One Reports First Quarter 2023 Financial Results and Corporate Progress

Eagle-Tribune 01 May 2023
Leadership team strengthened with executive appointments in clinical development and commercialization. Pre-New Drug Application (NDA) meeting held April 19, 2023 with U.S ... “We are also thrilled to announce the appointment of two industry veterans to Day One’s executive leadership team.

LianBio Announces China National Medical Products Administration (NMPA) Acceptance with ...

Enid News & Eagle 21 Apr 2023
“We are one step closer to bringing mavacamten to patients with obstructive HCM in China as a first-in-class, clinically validated treatment option,” said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio ... The NDA also includes clinical data from LianBio’s Phase 1 pharmacokinetic study of mavacamten in healthy Chinese volunteers.

Evolution Research Group, LLC Further Expands Early Phase Capabilities at Clinical Pharmacology of Miami (CPMI) ...

Victoria Advocate 12 Apr 2023
Prezioso, MD and Alfredo R ... CPMI specializes in the execution of complex early phase and NDA-enabling clinical trials in both healthy volunteers and special populations such as those suffering with renal insufficiency, hepatic impairment, diabetes, obesity, and many others ... Dr ... Dr ... Dr ... Dr ... Learn more about ERG by visiting ... ....

Ascendis Pharma Provides Update on Regulatory Reviews of TransCon PTH™ in Hypoparathyroidism

Eagle-Tribune 03 Apr 2023
This development a month from the agency’s PDUFA action date may lead to a delay in the FDA’s final regulatory decision on the TransCon PTH NDA,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer ... In the United States, Ascendis submitted its NDA for ...

Liquidia and GSK Restructure License to PRINT Technology for Inhaled Applications

Eagle-Tribune 03 Apr 2023
... timelines, including the potential for final FDA approval of the NDA for YUTREPIA and our ability to execute on our strategic or financial initiatives, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein.

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Russian President Vladimir Putin, left, and Belarusian President Alexander Lukashenko speak during their meeting at the Bocharov Ruchei residence in the resort city of Sochi, Russia, Friday, June 9, 2023.
AP / Gavriil Grigorov, Sputnik, Kremlin Pool Photo via AP