new drug application - Search News

FDA Clears Investigational New Drug Application for REC-4539 in SCLC

The FDA cleared the investigational new drug application for REC-4539, allowing for the start of a phase 1/2 trial in small cell lung cancer and other solid tumor indications.

MarketWatch · 2d

Solid Biosciences Gains FDA Clearance for New Drug Application

Solid Biosciences received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday.

Cure Today · 5d

FDA Accepts New Drug Application For Taletrectinib in ROS1+ NSCLC

The FDA has granted priority review to an NDA for taletrectinib in the treatment of advanced ROS1-positive non–small cell lung cancer.

Business Insider · 2d

Solid Biosciences's IND For Gene Therapy To Treat Friedreich's Ataxia Gets FDA Clearance

Tuesday announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SGT-212 for the treatment of Friedreich's ataxia (FA), a degenerative disease caused by insufficient levels of the frataxin protein.

TipRanks on MSN · 2d

Solid Biosciences gains 12% to $4.40 on FDA clearance of SGT-212 IND

EST Solid Biosciences (SLDB) gains 12% to $4.40 on FDA clearance of SGT-212 IND Published first on TheFly – the ultimate source for

JD Supra1d

Balancing Safety and Accessibility: FDA Broadens Approval Pathway for Nonprescription Drugs by Finalizing the ‘ACNU’ Rule

The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug ...

11h

Catalyst Pharmaceuticals Settles Patent Litigation Case With Teva Pharmaceutical

Catalyst Pharmaceuticals settles patent litigation with Teva, delaying generic Firdapse launch until 2035. Legal actions against other defendants remain ongoing.

Zacks.com on MSN9d

Corcept Submits Application for Another Cushing's Syndrome Drug

Corcept Therapeutics Incorporated CORT recently announced the submission of a new drug application (NDA) to the FDA for its ...

Healio1d

FDA grants priority review to oral non-small cell lung cancer drug

The FDA granted priority review to a new drug application for sunvozertinib as an oral treatment for certain patients with ...

MarketWatch10d

Corcept Therapeutics Submits New Drug Application for Cushing's Sydrome Treatment

Corcept Therapeutics submitted a new drug application to the Food and Drug Administration for its treatment of hypercortisolism, or Cushing's syndrome, a hormonal disorder that occurs when the ...

Business Wire10d

Verastem Oncology Announces FDA Acceptance and Priority Review of New Drug Application for Avutometinib in Combination with Defactinib for the Treatment of R…

Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, ...

10d

Chimerix Submits Dordaviprone New Drug Application for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma

This NDA submission marks a pivotal moment for Chimerix in our mission to bring this potentially life-altering drug to patients diagnosed with recurrent H3 K27M-mutant diffuse glioma,” said Mike ...

AMD invests $20M in AI-powered drug discovery company Absci

Absci will use AMD’s $20 million investment to enhance its AI models. In parallel, the companies will collaborate to develop ...

1don MSN

Vanda asserts FDA review of tradipitant was flawed

Vanda (VNDA) has written a letter to FDA Commissioner Robert Califf asserting that the review of the market application for ...

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