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REMS Modification Delays Approval of Ravulizumab for NMOSD

September 8, 2023

The FDA has issued a Complete Response Letter to AstraZeneca regarding the sBLA for ravulizumab-cwvz for neuromyelitis optica spectrum disorder.

Drug Administration Complete Response Letter Biologics License Application Ultomiris Risk Evaluation Mitigation Strategy Boxed Warning

Source: neurologyadvisor.com

REMS Modification Delays Approval of Ravulizumab for NMOSD

September 7, 2023

The FDA has issued a Complete Response Letter to AstraZeneca regarding the sBLA for ravulizumab-cwvz for neuromyelitis optica spectrum disorder.

Drug Administration Complete Response Letter Biologics License Application Ultomiris Risk Evaluation Mitigation Strategy Boxed Warning

Source: empr.com

Axsome Therapeutics Highlights Commitment to Innovating Treatments for Mental Health Conditions with Presentations at Psych Congress 2023

September 7, 2023

Data presentations explore effects on patient-centric efficacy measures of treatments for patients with depression, and excessive sleepiness associated with obstructive sleep apnea and narcolepsy NEW...

New York United States Mark Jacobson Darren Opland Andrew Cutler Manish Jha

Source: marketscreener.com

Amneal Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate

September 6, 2023

BRIDGEWATER, N.J.--(BUSINESS WIRE)--Sep 6, 2023--

United States Anthony Dimeo Andrew Boyer Amneal Pharmaceuticals Inc Drug Administration Exchange Commission

Source: eagletribune.com

Brixadi Now Available for Weekly or Monthly Administration to Treat Opioid Use Disorder

September 5, 2023

Brixadi® (buprenorphine) extended-release subcutaneous injection is now available for the treatment of moderate to severe opioid use disorder.

Paul Johnson Boxed Warning Risk Evaluation Mitigation Strategy Chief Commercial Officer

Source: empr.com

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Delcath Systems to Participate at the H.C. Wainwright 25th Annual Investor Conference on September 12 and 13, 2023

September 5, 2023

/PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the...

United States United Kingdom Gerard Michel Ben Shamsian Delcath Systems Inc Delcath Systems

Source: prnewswire.com

Vyvanse Generic Approved by FDA: ADHD Medication Update

September 1, 2023

Vyvanse generic, lisdexamfetamine dimesylate, has received FDA approval, easing cost and accessibility barriers to the ADHD stimulant medication.

United States William Dodson Drug Enforcement Agency American Academy Of Child Drug Administration Mcgill University

Source: additudemag.com

Delcath Systems, Inc. Announces Additional $35 Million in Funding Tied to the FDA Approval of HEPZATO KIT™

September 1, 2023

/PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the...

United States United Kingdom Ben Shamsian Gerard Michel Prnewswire Delcath Systems Inc Access Program

Source: prnewswire.com

Delcath Systems, Inc. Announces Additional $35 Million in Funding Tied to the FDA Approval of HEPZATO KIT™

September 1, 2023

NEW YORK, Sept. 1, 2023 /PRNewswire/ -- Delcath Systems, Inc. , an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced today that it...

United States United Kingdom Ben Shamsian Gerard Michel Exchange Commission Prnewswire Delcath Systems Inc

Source: marketscreener.com