MindMed's LSD Anxiety Drug: Revisiting, Rethinking, But Maintaining My 'Hold' Call
Inc. stock despite strong Phase 2b data. Click for my updated look at MNMD stock and its market opportunities.
Granules India Limited receives final approval from USFDA for its new drug
Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and ...
Vanda Pharmaceuticals Files for New Drug Application for Tradipitant for Motion Sickness Treatment
Vanda Pharmaceuticals Inc. recently made a significant move by filing a new drug application for Tradipitant. The application, targeted at addressing motion sickness, was publicized through a social ...
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FDA approves drug application for Lupin’s heart failure therapy
The US Food and Drug Administration (FDA) has approved the abbreviated new drug application (ANDA) of Lupin’s Sacubitril and ...
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FDA and EMA Accepts Applications for New Nusinersen Regimen
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines ...
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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 ...
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Bayer expands indications for Nubeqa with new drug application
TheUS Food and Drug Administration (FDA) has accepted Bayer’s supplemental new drug application (sNDA) for its oral androgen receptor inhibitor (ARi), for the treatment of patients with ...
Testing Thousands of Compounds Simultaneously to Uncover New Drugs and Tailored Treatments
Scientists have unveiled a groundbreaking method to test how thousands of active substances influence cellular metabolism ...
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
We are pleased to announce that our applications for the higher dose regimen of nusinersen are now under review in the US and Europe,” said Stephanie Fradette, Pharm.D., Head of the Neuromuscular ...