New Drug Application FDA

FDA, Spravato and Major depressive disorder

J&J's Depression Drug Spravato Gets FDA Nod for Monotherapy Use

Johnson & Johnson JNJ announced that the FDA has approved its supplemental new drug application (sNDA), seeking approval for Spravato (esketamine) as a monotherapy for adults living with treatment-resistant depression (TRD).

Healio · 10h

FDA approves Spravato as monotherapy for adults with major depressive disorder

The FDA has approved a supplemental new drug application for Spravato, an esketamine nasal spray that can be used as monotherapy for adults with treatment-resistant depression, Johnson & Johnson announced in a press release.

U.S. News & World Report · 9h

FDA Approves Spravato Nasal Spray for Treatment-Resistant Depression

The U.S. Food and Drug Administration has approved Spravato (esketamine) CIII nasal spray for adults living with major depressive disorder who have had an inadequate response to at least two oral antidepressants,

FDA, Atara and New Drug Applications

ophthalmologytimes · 11d

FDA accepts revised supplemental New Drug Application for IZERVAY

The application was refiled following a December 20, 2024, meeting between the US Food and Drug Administration and Astellas.

MarketWatch · 1d

Atara's New Drug Applications Placed on Hold by FDA

Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications. The biotechnology company said the FDA put a hold on its Ebvallo and ATA3219 programs due to compliance issues at a third-party manufacturing facility.

Business Insider · 14h

Atara Biotherapeutics Faces Strategic Uncertainty Amid FDA Hold and CRL Issues

H.C. Wainwright analyst Robert Burns has reiterated their neutral stance on ATRA stock, giving a Hold rating yesterday.Invest with Confidence:

BioSpace13h

FDA Presses Pause on Atara’s Programs, Play on Amylyx’s ALS Assets

The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a ...

Business Wire5d

Arrowhead Pharmaceuticals Announces Acceptance of New Drug Application by U.S. FDA of Plozasiran for the Treatment of Familial Chylomicronemia Syndrome

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...

12hon MSN

Scilex FDA submission for ELYXYB acute pain treatment acknowledged

PALO ALTO, Calif. - Scilex Holding Company (NASDAQ:SCLX), a $77.5 million market cap company known for its focus on non-opioid pain management products, reported that the U.S. Food and Drug ...

JD Supra5d

FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for Nonprescription Use

The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...

pulmonologyadvisor1d

FDA Drug Approval Decisions Expected in February 2025

The FDA is reviewing new vaccines for meningitis and chikungunya and therapies for Parkinson disease and PTSD.

Healio7d

FDA clears investigational new drug application for lorundrostat in OSA, hypertension

The FDA approved the phase 2 Explore-OSA trial set to assess the highly selective aldosterone synthase inhibitor, ...

Targeted Oncology7d

FDA Considers TAR-200 in BCG-Unresponsive High-Risk NMIBC

An FDA application for TAR-200 to treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer is under real-time ...

JD Supra2d

Drugs and Biologics at FDA: Reflections on 2024 Activity Shed Light on the Road Ahead

With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...

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