Veru Announces Successful Completion of Pre-NDA Meeting with FDA for TADFIN (Tadalafil 5mg and Finasteride 5mg) Combination for the Treatment of Benign Prostatic Hyperplasia
Veru Inc. (VERU)
Last veru inc. earnings: 2/12 06:30 am
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Source: GlobeNewswire
--Reached Agreement with FDA on Regulatory Package for NDA Submission Utilizing the 505(b)(2) Expedited Regulatory Pathway—-- TADFIN is a First Novel Combination Formulation of Tadalafil and Finasteride for the Treatment of BPH with NDA Submission Anticipated in Summer of 2020-- MIAMI, June 26, 2019 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company developing novel medicines for prostate cancer treatment and prostate cancer supportive care, today announced that the Company concluded its pre-New Drug Application ("NDA") meetings with the U.S. Food and Drug Administration ("FDA") for TADFIN® (tadalafil 5mg and finasteride 5mg combination) formulation for the treatment of benign prostatic hyperplasia (BPH). The purpose of the meeting was to discuss the proposed NDA and to confirm the clinical, non-clinical, and chemistry, manufacturing and controls (CMC) requirements for the Company's NDA submission utilizing the FDA expedited 505(b)(2)
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- Veru to Present at the American Association of Clinical Endocrinology (AACE) 2024 Annual Meeting on May 9-11GlobeNewswire
- What Makes Veru (VERU) a New Buy Stock [Yahoo! Finance]Yahoo! Finance
- Veru Inc. (NASDAQ: VERU) had its "outperform" rating re-affirmed by analysts at Oppenheimer Holdings Inc.. They now have a $5.00 price target on the stock, down previously from $7.00.MarketBeat
- Veru Announces Date of 2024 Annual Meeting of Shareholders [Yahoo! Finance]Yahoo! Finance
VERU
Earnings
- 8/10/23 - Beat
VERU
Sec Filings
- 4/25/24 - Form 8-K
- 4/24/24 - Form SC
- 4/1/24 - Form DEFA14A
- VERU's page on the SEC website