FDA Premarket Approval [PMA] Architect Hbsag Next Qualitative/next Confirmatory Abbott Laboratories fda.report/PMA/P210003S003 $ABT

FDA Premarket Approval [PMA] Angiojet Spiroflex Thrombectomy Set, Angiojet Spir Boston Scientific Corp. fda.report/PMA/P980037S089 $BSX $BSX.PA

FDA Premarket Approval [PMA] Architect Hbsag Qualitative/confirmatory/alinity H Abbott Laboratories fda.report/PMA/P110029S040 $ABT

FDA Premarket Notification [PMN] Inogen Rove 4 Portable Oxygen Concentrator Inogen fda.report/PMN/K222086 $INGN

FDA Premarket Notification [PMN] Filter Carestar Plus, Filter Safestar Plus, Filter/hme Twinstar Plus Drägerwerk AG & Co. KGaA fda.report/PMN/K221836 $DRW8 [XETRA]

FDA Premarket Notification [PMN] Dexcom G7 Continuous Glucose Monitoring System Dexcom, Inc. fda.report/PMN/K213919 $DXCM

FDA New Drug Application NDA216340 MIRATI THERAPEUTICS, INC fda.report/applications/2… $MRTX

FDA New Drug Application NDA214860 ACER THERAPEUTICS INC fda.report/applications/2… $ACER

FDA Abbreviated New Drug Application ANDA215077 ALEMBIC PHARMS LTD fda.report/applications/2… $533573 [BOMBAY STOCK EXCHANGE LTD. (MUMBAI)]

FDA New Drug Application NDA215973 GILEAD SCIENCES fda.report/applications/2… $GILD

FDA New Drug Application NDA215974 GILEAD SCIENCES fda.report/applications/2… $GILD

FDA Abbreviated New Drug Application ANDA216357 GLENMARK PHARMS LTD fda.report/applications/2… $532296 [BOMBAY STOCK EXCHANGE LTD. (MUMBAI)]

FDA Abbreviated New Drug Application ANDA217054 TWI PHARMS fda.report/applications/2… $4180 [GRE TAI SECURITY MARKET]

FDA Biologics License Applications BLA761192 MEDIWOUND, LTD fda.report/applications/7… $MDWD

FDA Biologics License Applications BLA761238 TG THERAPEUTICS, INC fda.report/applications/7… $TGTX

FDA Abbreviated New Drug Application ANDA205930 LUPIN LTD fda.report/applications/2… $500257 [BOMBAY STOCK EXCHANGE LTD. (MUMBAI)]

FDA Abbreviated New Drug Application ANDA213120 LUPIN LTD fda.report/applications/2… $500257 [BOMBAY STOCK EXCHANGE LTD. (MUMBAI)]

FDA New Drug Application NDA214544 LUPIN LTD fda.report/applications/2… $500257 [BOMBAY STOCK EXCHANGE LTD. (MUMBAI)]

FDA Abbreviated New Drug Application ANDA216775 ALEMBIC PHARMS LTD fda.report/applications/2… $533573 [BOMBAY STOCK EXCHANGE LTD. (MUMBAI)]

FDA New Drug Application NDA217639 STEMLINE THERAPEUTICS INC fda.report/applications/2… $STML [NASDAQ]