Archive for the Category ‘FDA Updates’

FDA Watchlist: Updates for Cardium, AstraZeneca, Amylin, Osteotech

FDA Watchlist: Updates for Cardium, AstraZeneca, Amylin, Osteotech

Updates for: Cardium Therapeutics (AMEX:CXM), AstraZeneca plc (ADR) (NYSE:AZN), Amylin Pharmaceuticals (NASDAQ:AMLN), and Osteotech, Inc. (NASDAQ:OSTE)
Cardium Therapeutics Inc.
(AMEX:CXM)

On 12/3/09, Cardium (CXM) announced that its wholly-owned subsidiary (Tissue Repair Company) submitted a 510(k) premarket notification filing with the FDA seeking marketing clearance of its Excellagen product candidate. The 510k submission covers ExcellagenXL and ExcellagenFX, advanced wound [...]

FDA Watchlist: Updates for Novo Nordisk, IntelGenx Corp, Cytomedix Inc, Par Pharmaceutical Companies

FDA Watchlist: Updates for Novo Nordisk, IntelGenx Corp, Cytomedix Inc, Par Pharmaceutical Companies

Updates for: Novo Nordisk (NYSE:NVO), IntelGenx Corp. (OTC:IGXT), Cytomedix Inc. (AMEX:GTF), and Par Pharmaceutical Companies Inc. (NYSE:PRX)
Warner Chilcott PLC
(NYSE:NVO)

On 9/23/09, Novo Nordisk (NYSE: NVO) announced the delay until 4Q09 of formal feedback from the FDA for its pending Victoza (liraglutide is a once-daily human GLP-1 analogue) NDA seeking U.S. marketing approval for the treatment of [...]

Electronic Cigarette Wholesaler Empowered After U.S. Judge Decision Against FDA

Electronic Cigarette Wholesaler Empowered After U.S. Judge Decision Against FDA

Mobile Media Unlimited Holdings Inc.
(OTC:

Landmark Victory for E-Cigarette Industry Against the FDA Leaves Plenty of Opportunities

Landmark Victory for E-Cigarette Industry Against the FDA Leaves Plenty of Opportunities

Mobile Media Unlimited Holdings Inc
(OTC:MMUH)
If you don’t already know, the hottest new investment fad to hit Wall Street since mobile portfolio management can be summed up in two short words, “electronic cigarettes”. While your favourite celebrities may still be hitting the paper and casually smoking themselves closer to cancer and other complications, others are finding [...]

FDA Watchlist: Updates for Warner Chilcott, AstraZeneca, Dainippon Sumitomo, Nanosphere

FDA Watchlist: Updates for Warner Chilcott, AstraZeneca, Dainippon Sumitomo, Nanosphere

Updates for: Warner Chilcott PLC (NASDAQ:WCRX), AstraZeneca PLC (NYSE:AZN), Dainippon Sumitomo Pharma (PINK:DNPUF), and Nanosphere, Inc. (NASDAQ:NSPH)
Warner Chilcott PLC
(NASDAQ:WCRX)

On 5/27/09, Warner Chilcott (NASDAQ: WCRX) announced that the FDA has filed for standard review (10 months) the new drug application (NDA) for WC 3016, a low dose oral contraceptive. The NDA for WC 3016 was submitted [...]

Biotech FDA Mailbag: Updates for Bovie Medical, Acorda Therapeutics

Biotech FDA Mailbag: Updates for Bovie Medical, Acorda Therapeutics

Updates for: Bovie Medical Corporation (AMEX:BVX), and Acorda Therapeutics (NASDAQ:ACOR)
The following is a list of companies which includes the company name, ticker symbol, decision date, and the lastest updated description and notes. Each entry includes a summary of the pending regulatory or clinical trial catalyst event and other relevant information such as FDA Advisory Panel [...]

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