Detailed price information for Lexaria Bioscience Corp (LEXX-Q) from The Globe and Mail including charting and trades.
The U.S. Food and Drug Administration has approved Yuvezzi (carbachol and brimonidine tartrate) ophthalmic solution 2.75%/0.1 ...
FDA warning letter data reveals the same top 10 compliance issues have plagued medtech for 20 years, with CAPAs leading at 12 ...
Leerink analyst Roanna Ruiz was not surprised that Aquestive Therapeutics (AQST) received a Complete Response Letter for ...
Aquestive Therapeutics recently received a Complete Response Letter from the FDA for its Anaphylm sublingual epinephrine film, with concerns focused on packaging, labeling, and instructions for use ...
Aquestive has received a CRL from the FDA regarding its NDA for Anaphylm, which aims to treat type I allergic reactions in patients weighing 30kg or more.
Aquestive Therapeutics announced it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for Anaphylm (dibutepinephrine) Sublingual Film, a noninvasive ...
Aquestive received an FDA rejection for its allergy film due to safety and use issues. The company plans new studies and ...
Aquestive Therapeutics (NASDAQ:AQST) shares surged 18% on Monday even after the company disclosed that it had received a ...
Deficiencies limited to packaging and administrationCompany believes it can rapidly resolve deficiencies and expects to resubmit as early as Q3 ...
Investing.com -- Aquestive Therapeutics (NASDAQ:AQST) stock rose 18% Monday despite the company announcing it received a complete response letter (CRL) from the U.S. Food and Drug Administration for ...
For companies developing interchangeable biosimilars, the FDA guidance opens the door to more tailored, risk-based programs that may reduce reliance on costly comparative efficacy studies (CES). For ...