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 ...
Green Market Report2d
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 ...
Crain's Chicago Business2d
Xeris enters a whole new market for one of its main pharma offerings
Xeris Biopharma Holdings has received regulatory approval for a new use of its Gvoke liquid glucagon in gastrointestinal ...
JD Supra6h
New SEC Leadership Signals Continued Focus on FDA-Related Disclosures
Lawyers inside and outside the US Securities and Exchange Commission (SEC) have speculated that the agency’s new leadership will take a ...
PDS Biotech gets IND application clearance for colorectal cancer treatment
PDS Biotechnology (NASDAQ:PDSB) said on Thursday it received U.S. FDA clearance for its Investigational New Drug application ...
Access to Compounded GLP-1s Is Drying Up. Here’s What to Know About the Copycat Weight-Loss Drugs.
To be a person in the year 2025 is to encounter, in one way or another, the marketing onslaught for compounded ...
Ophthalmology Times10d
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.
Healio10d
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 ...
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 ...
Healio29d
FDA clears investigational new drug application for Zabalafin Hydrogel
Phase 2b and phase 3 trials may begin in 2025 and 2026, respectively. A new drug application is anticipated for 2029. The investigational new drug application for Zabalafin Hydrogel for the ...