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In a recent webinar, industry experts explain how real-world data and patient-centric support can shape regulatory success ...
The FDA has issued more than 200 complete response letters, which detail reasons for non-approval of drug applications.
IGI Therapeutics has signed an exclusive licensing agreement with AbbVie, for ISB 2001 to treat cancer and autoimmune diseases.
BeOne Medicines has secured approval from the EC for Tevimbra (tislelizumab) to be used along with gemcitabine and cisplatin to treat NPC.