Telix Pharmaceuticals' New Drug Application for Prostate Imaging Drug Gets FDA Approval
Telix Pharmaceuticals' said its new drug application in the U.S. for an imaging agent received regulatory approval. The Melbrourne, Australia-based biopharmaceutical company said Friday that the Food ...
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NRx pharmaceuticals files New Drug Application for ketamine depression treatment
The clinical-stage biopharmaceutical firm is pushing its NMDA platform while building a national network of psychiatric ...
Capacity push and new drugs critical for Aurobindo's health
A delay in drug approvals in the US market remains a concern for Aurobindo. The company stated that eight ANDAs (abbreviated ...
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FDA accepts new drug application for SYD-101 to treat pediatric myopia progression
The FDA accepted a new drug application for SYD-101 to slow the progression of pediatric myopia and assigned a Prescription ...
Ophthalmology Times11d
FDA accepts new drug application for low-dose atropine from Sydnexis
The FDA has set a PDUFA target action date of October 23, 2025, for the low-dose atropine formulation.
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FDA advances new drug application for ketamine
Specialty pharmaceutical company PharmaTher Holdings’ drug application for Ketamine has received a June 4 approval goal date, advancing approval of the drug in the U.S. PharmaTher said it is ...
Prince Harry's secret visa files released - but key question remains over drug use
The conservative Heritage Foundation had campaigned to have Prince Harry's Visa application released after he admitted to ...
Can you get into the USA if you’ve ever taken drugs?
Notable recipients include Lord Andrew Lloyd-Webber, Boy George, Liam Payne, and Justin Bieber. As far as drugs are concerned ...
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FDA Files Corcept’s New Drug Application for Relacorilant as Treatment for Patients With Hypercortisolism
"The FDA’s acceptance of our New Drug Application takes us another step closer to bringing relacorilant to patients with hypercortisolism," said Joseph Belanoff, M.D., Corcept’s Chief ...