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Two Arnall Golden Gregory attorneys outline highlights in a new FDA question-and-answer guidance on expanded access and suggest wa...[ Price : $8.95]
Sen. Tom Cotton poses questions for attorney general Pam Bondi about the Justice Departments activities to stop counterfeit drugs ...[ Price : $8.95]
Novartis asks FDA to restrict ANDAs or 505(b)(2) NDAs citing the companys Leqvio as the reference-listed drug.[ Price : $8.95]
Texas attorney general Ken Paxton reaches a $41.5 million settlement with Pfizer and Tris Pharma after accusing the companies of p...[ Price : $8.95]
Sun Pharma Advanced Research Company says that Ocuvex Therapeutics has resubmitted an NDA for PDP-716, more than two years after t...[ Price : $8.95]
FDA issues a Warning Letter to Cdymax India Pharma Private Limited after inspectors uncovered CGMP violations at the companys acti...[ Price : $8.95]
Merck reports that its drug Winrevair (sotatercept-csrk) significantly improved a key measure of heartlung function in a mid-stage...[ Price : $8.95]
FDA releases the form FDA-483 issued following an inspection at the Milan, Italy-based NerPharMa drug manufacturing facility.