Previous 10 | Next 10 |
Company is on track with ongoing repeat-dose study under allergen-induced allergic rhinitis conditions requested by U.S. FDA with topline data expected in Q1 2024 Resubmission of New Drug Application (NDA) for neffy ® anticipated in H1 2024 Ended thi...
Data to be Presented in Four Oral Presentations and Posters at the 2023 American College of Allergy, Asthma and Immunology Annual Scientific Meeting Supports neffy’s potential to be a safe and effective option across patient sub-populations based on data including the...
SAN DIEGO, Oct. 06, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc . (NASDAQ: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today announced that the United...
neffy resulted in robust responses on pharmacodynamic (PD) surrogates of efficacy observed even at 1 minute after dosing, and which were comparable to, or greater in magnitude than, EpiPen Repeat doses of neffy resulted in statistically greater mean maximum responses o...
NEW YORK, NY / ACCESSWIRE / September 22, 2023 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of ARS Pharmaceuticals, Inc. ("ARS" or "the Company") (NASDAQ:SPRY). Investors who purchased ARS securities are encouraged to obtain additional inform...
BOSTON, MA / ACCESSWIRE / September 20, 2023 / Block & Leviton is investigating ARS Pharmaceuticals, Inc. (NASDAQ:SPRY) for potential securities law violations. Investors who have lost money in their ARS Pharmaceuticals investment should contact the firm to learn more about how they might ...
Company aligned with FDA in August 2023 on both physician labeling and post-market requirements, which included a repeat-dose study of neffy under allergen-induced allergic rhinitis conditions FDA Advisory Committee (PADAC), held in May 2023, recommended neffy ap...
ARS continues engagement with U.S. FDA on final labeling and post-marketing commitments for the neffy® new drug application; PDUFA target action date set for September 19, 2023 Ended second quarter with $252.2 million in cash, cash equivalents and short-term investments...
SAN DIEGO, June 20, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc . (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today announced that the ...
FDA Advisory Committee Votes in Support of Favorable Benefit-Risk Profile for neffy ® for the Treatment of Allergic Reactions (Type I), Including Anaphylaxis New Drug and Marketing Authorization Applications for neffy Under Review with FDA and EMA, Respectivel...
News, Short Squeeze, Breakout and More Instantly...
Silverback Therapeutics Inc. Company Name:
SBTX Stock Symbol:
NASDAQ Market:
neffy ® (epinephrine nasal spray) New Drug Application (NDA) and CRL response under review by FDA with anticipated review completion by early October 2024 Response submitted for neffy Marketing Authorization Application (MAA) to EMA’s CHMP; CHMP...
CHMP opinion on neffy Marketing Authorization Application anticipated in the second quarter of 2024 Response addresses all issues previously identified by CHMP, and includes results from a repeat dose PK/PD study of neffy under NAC conditions and updated ...
Response addresses all additional requests in FDA CRL, including positive data from a repeat dose PK/PD study of neffy under nasal allergen challenge (NAC) conditions, and updated testing that detected no measurable nitrosamine levels, conducted per August 2023 FDA Guidance Submission...