BioCentury | Mar 9, 2019
Regulation

Gottlieb’s exit interview

...potential (see “Turning the Tide” ). Gottlieb thinks the public conversation over approval of Dsuvia sufentanil...
BioCentury | Jan 12, 2019
Finance

We all fall down

...episodes in Parkinson's disease patients treated with carbidopa-levodopa AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) FDA approves Dsuvia sufentanil...
BioCentury | Nov 9, 2018
Clinical News

FDA approves AcelRx, Coherus, Pfizer Products, rebuffs Trevena's Olinvo

...for the indication. AcelRx gained $0.65 (16%) to $4.80 Nov. 2 when FDA approved Dsuvia sufentanil...
...City, Calif. Pfizer Inc. (NYSE:PFE), New York, N.Y. Trevena Inc. (NASDAQ:TRVN), Chesterbrook, Pa. Product: Dsuvia sufentanil...
BioCentury | Nov 2, 2018
Company News

FDA approves AcelRx, Coherus, Pfizer products, rebuffs Trevena's Olinvo

...Europe for the indication. AcelRx gained $0.65 (16%) to $4.80 Friday when FDA approved Dsuvia sufentanil...
BioCentury | Nov 2, 2018
Company News

Gottlieb justifies approval of Dsuvia, a new opioid

...a new opioid analgesic, Commissioner Scott Gottlieb Friday explained the agency’s decision to approve Dsuvia sufentanil...
BioCentury | Oct 19, 2018
Clinical News

FDA panel votes in favor of AcelRx's pain candidate

...Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 that the benefit-risk profile of Dsuvia sufentanil...
...letter from FDA in October 2017 for the candidate, which delivers a sublingual formulation of sufentanil...
...Dsuvia sufentanil sublingual tablet (ARX-04) Business: Neurology Elizabeth S. Eaton Dsuvia, Dzuveo, Sufentanil sublingual tablet (ARX-04, single-dose sufentanil...
BioCentury | Oct 12, 2018
Company News

FDA panel votes in favor of AcelRx's pain candidate

...Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 that the benefit-risk profile of Dsuvia sufentanil...
...letter from FDA in October 2017 for the candidate, which delivers a sublingual formulation of sufentanil...
...$0.88 (22%) to $4.86 in after-hours trading. Elizabeth S. Eaton Dsuvia, Dzuveo, Sufentanil sublingual tablet (ARX-04, single-dose sufentanil...
BioCentury | Oct 6, 2018
Finance

Seeking validation

...NYSE:ABBV) Upadacitinib (ABT-494) Rheumatoid arthritis Submit reg apps worldwide 4Q18 AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) Dsuvia sufentanil...
BioCentury | Sep 13, 2018
Clinical News

Advisory committee meeting Oct. 12 to discuss NDA for Acelrx's Dsuvia

...will meet Oct. 12 to discuss an NDA from AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) for Dsuvia sufentanil...
...for Dsuvia (see “AcelRx’s Dsuvia Gets CRL” ). The product is a sublingual formulation of sufentanil...
...Dsuvia sufentanil sublingual tablet (ARX-04) Business: Neurology Jaime De Leon Dsuvia, Dzuveo, Sufentanil sublingual tablet (ARX-04, single-dose sufentanil...
BioCentury | Jun 30, 2018
Finance

Eyes on launches

...NASDAQ:CELG) Luspatercept (ACE-536) Beta-thalassemia Top-line Ph III BELIEVE data Mid-2018 AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) Dsuvia sufentanil...
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