Clearside Biomedical Provides New Drug Application Update for XIPERE?? (triamcinolone acetonide suprachoroidal injectable suspension)
Clearside Biomedical, Inc. (CLSD)
Last clearside biomedical, inc. earnings: 3/11 04:05 pm
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Source: GlobeNewswire
ALPHARETTA, Ga., Aug. 22, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today an update regarding the Company’s 505(b)(2) New Drug Application (NDA) for XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension) with the U.S. Food and Drug Administration (FDA). In a meeting this week, the FDA’s Office of Pharmaceutical Quality (OPQ) requested that Clearside provide stability data for the triamcinolone acetonide (TA) suspension produced utilizing an enhanced manufacturing process implemented by the Company. The formulation of the TA suspension has not changed; however, OPQ requested the data to verify the comparability of the stability profiles of the batches made with the enhanced manufacturing process with that of the batches originally submitted as part of the NDA. The requested
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News
- Clearside Biomedical Appoints Seasoned Biotechnology Executive Anthony S. Gibney to its Board of Directors [Yahoo! Finance]Yahoo! Finance
- Clearside Biomedical Appoints Seasoned Biotechnology Executive Anthony S. Gibney to its Board of DirectorsGlobeNewswire
- Clearside Biomedical, Inc. (NASDAQ: CLSD) had its "buy" rating re-affirmed by analysts at Needham & Company LLC. They now have a $4.00 price target on the stock.MarketBeat
- Clearside Biomedical to Participate in Fireside Chat at the 23rd Annual Needham Virtual Healthcare Conference [Yahoo! Finance]Yahoo! Finance
- Clearside Biomedical to Participate in Fireside Chat at the 23rd Annual Needham Virtual Healthcare ConferenceGlobeNewswire
CLSD
Earnings
- 3/12/24 - Beat
CLSD
Sec Filings
- 4/19/24 - Form 4
- 4/16/24 - Form 4
- 4/16/24 - Form 3
- CLSD's page on the SEC website