Browsing Tag
FDA
293 posts
Celltrion’s YUFLYMA gains full FDA interchangeability: What it means for U.S. biosimilar market
Discover how Celltrion’s YUFLYMA earned full FDA interchangeability, boosting biosimilar adoption and reshaping the U.S. immunology drug market.
Novavax shares rally after FDA approves non-mRNA COVID-19 vaccine for at-risk groups
Novavax stock surged 25% after FDA approved its non-mRNA COVID-19 vaccine Nuvaxovid. Find out what triggered this rally and what it means for investors.
Hims & Hers Health soars over 10% after Wegovy rollout, Q1 strength, and analyst upgrades
Hims & Hers Health stock jumped 10.36% on May 16, 2025, after a Wegovy rollout, strong Q1 earnings, and analyst upgrades boosted investor confidence.
TransMedics stock jumps nearly 20% after Q1 results, regulatory tailwinds for OCS heart system
Why Did TransMedics Stock Rise Nearly 20%? TransMedics Group, Inc. (NASDAQ: TMDX) witnessed a sharp surge of 19.64%…
Prescient Therapeutics secures FDA fast track for PTX-100 to advance CTCL treatment strategy
Find out how Prescient Therapeutics’ PTX-100 just gained FDA Fast Track status, accelerating the path to treating relapsed CTCL.
Johnson & Johnson’s next-gen surgical robot OTTAVA enters operating rooms for the first time
Find out how Johnson & Johnson MedTech's OTTAVA robotic surgical system is advancing minimally invasive surgery with its first completed clinical trial cases.
Abbott advances coronary artery disease treatment with new intravascular lithotripsy trial
Abbott’s Coronary Intravascular Lithotripsy (IVL) System gets FDA approval for a clinical trial to enhance coronary artery disease treatment—learn more.
Danone faces quality concerns as FDA recalls International Delight coffee creamers
Danone North America has issued a voluntary recall of over 75,000 bottles of International Delight coffee creamer following…
Laplace Interventional advances life-saving heart valve technology with $22m funding round
Laplace Interventional, a Minnesota-based medical device company pioneering transcatheter tricuspid valve replacement technology, has secured $22 million in…
Sanofi advances flu vaccine production with FDA-approved strains for 2025-26 season
Sanofi has confirmed that it is advancing its flu vaccine production for the 2025-26 flu season, aligning with…