Nasdaq9d
Biotech Stocks Facing FDA Decision In March 2025
The FDA has approved five novel drugs so far this year. Now, let's take a look at the biotech stocks facing FDA decisions in March 2025. The views and opinions expressed herein are the views and ...
Nasdaq5d
OKYO Pharma Files for Fast Track Designation with FDA for Urcosimod to Treat Neuropathic Corneal Pain
“Fast track was first introduced by FDA to expedite development and review ... About OKYOOKYO Pharma Limited (NASDAQ: OKYO) is a clinical stage biopharmaceutical company developing innovative ...
Nasdaq8d
QGEN Stock Up on FDA Nod for Second QIAstat-Dx Gastrointestinal Panel
QIAGEN N.V. QGEN has secured FDA clearance for its QIAstat-Dx Gastrointestinal ... Just Released: Zacks Top 10 Stocks for 2025 Hurry – you can still get in early on our 10 top tickers for ...
Nasdaq8d
Stereotaxis Stock Slides Despite MAGiC Sweep Catheter FDA Submission
Stereotaxis STXS recently submitted an application seeking FDA regulatory clearance for its ... Just Released: Zacks Top 10 Stocks for 2025 Hurry – you can still get in early on our 10 top ...
REGENXBIO Inc. (NASDAQ:RGNX) Q4 2024 Earnings Call Transcript
Q4 2024 Earnings Call Transcript March 13, 2025 REGENXBIO Inc. beats earnings expectations. Reported EPS is $-1.01, ...
Nasdaq10d
Roche Gets FDA Approval for Acute Ischemic Stroke Drug for Adults
The FDA approval is based on a large multi-center ... We want you to get acquainted with our portfolio services like Surprise Trader, Stocks Under $10, Technology Innovators,and more, that ...
Nasdaq10d
FDA Accepts Supplemental Biologics License Application for Genentech’s Gazyva for the Treatment of Lupus Nephritis
“The FDA’s sBLA acceptance for Gazyva recognizes the need to provide a more effective treatment option for people living with this devastating disease.” “Lupus nephritis is a debilitating ...
Nasdaq11d
ANI Pharmaceuticals Receives FDA Approval For Purified Cortrophin Gel Prefilled Syringe
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...
Nasdaq22d
Teva Pharmaceuticals and Alvotech Announce FDA Approval of SELARSDI™ Biosimilar for Multiple Indications
The FDA's provisional determination of interchangeability ... Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) today announced the availability of SELARSDI (ustekinumab-aekn ...
Nasdaq26d
FDA Approves Merilog Rapid-Acting Insulin Biosimilar For Diabetes
The FDA noted that Merilog is the third insulin ... and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...
Nasdaq5d
Biodexa Announces Successful Outcome of a Type C Meeting with FDA Regarding the Phase 3 Program for eRapa in FAP
Learn more at https://cprit.texas.gov/. About Biodexa Pharmaceuticals PLC Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline ...
Nasdaq25d
Spectral AI Strengthens Financial Position Ahead of FDA Submission
DALLAS, Feb. 18, 2025 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI ... Designation from the U.S. Food and Drug Administration (“FDA”) in 2018 and uses multi-spectral imaging and AI ...