Related by context. Frequent words. (Click for all words.) 79 Complete Response letter 75 Approvable Letter 69 approvable letter 66 Warning Letter 60 Staff Determination Letter 58 Marketing Authorization Application 58 PDUFA date 58 European Medicines Evaluation 58 Biologics License Application 57 New Drug Application 57 Staff Deficiency Letter 57 Marketing Authorization Application MAA 57 Biologics License Application BLA 56 sNDA 55 resubmission 54 CHMP 54 L MTP PE 53 Fast Track designation 52 Drug Application 52 DISCLOSURE NOTICE 52 Marketing Authorization 52 Orphan Drug designation 52 Staff Determination 52 Palatin Technologies Inc. 51 sBLA 51 APF# 51 NDA submission 51 pediatric exclusivity 51 Priority Review 50 Medicinal Products 50 Fast Track Designation 50 Horizant 50 EPIX Pharmaceuticals 49 Orphan Drug Designation 49 pegloticase 49 SILENOR TM 49 BENLYSTA 49 FavId 48 Earnings Guidance 48 PROMACTA 48 eltrombopag 48 alogliptin 48 Exalgo 48 Act PDUFA 48 Zenvia 48 Afrezza 48 vilazodone 48 pralatrexate 48 Requisite Consents 48 Default Status Report 48 Listing Qualifications Panel 48 Mitigation Strategy REMS 47 Shareholder Update 47 Continued Listing 47 BYDUREON 47 FDA 47 Neupro ® 47 FDA Approval 47 PDUFA 47 stockholder approvals 47 milnacipran 47 CoFactor 47 Completes Enrollment 47 Drug Candidate 47 QRxPharma 47 Drug Administration FDA 47 ADVEXIN 47 NUVIGIL 47 iloperidone 47 SFDA approval 47 FDA reviewers 47 Torisel 46 Oral Suspension 46 investigational compound 46 Marqibo 46 TORISEL 46 ATryn R 46 Abbreviated New 46 CDER 46 Phase IIa trial 46 PRX # 46 FENTORA 46 Lumizyme 46 Special Protocol Assessment 46 methylnaltrexone 46 cutaneous T cell 46 ecallantide 46 Apricus Bio 46 indiplon 46 CORLUX 46 approvable 46 Replagal 46 Palatin Technologies 46 KRYSTEXXA 46 Cladribine Tablets 45 Drugs Advisory 45 diabetic neuropathic pain 45 LIALDA 45 PhosLo 45 bioequivalence 45 ONSOLIS