Browsing Tag
FDA
293 posts
FDA approves Bayer’s Lynkuet, a first-in-class dual NK-1/NK-3 antagonist for menopausal hot flashes
Find out how Bayer’s Lynkuet is changing menopause care with the first dual-neurokinin receptor antagonist approved by the FDA for hot flashes!
Scienture starts commercial rollout of Arbli, the first FDA-approved losartan oral suspension
Find out how Scienture is changing the hypertension treatment market with the FDA-approved Arbli losartan oral suspension.
QRX003 by Quoin Pharmaceuticals earns FDA orphan drug designation, signaling hope for Netherton Syndrome patients
Find out how Quoin Pharmaceuticals is changing rare-disease treatment today with its QRX003 orphan drug win — read more now!
Minerva Neurosciences gains up to $200m to advance Roluperidone toward FDA approval and U.S. market launch
Minerva Neurosciences secures up to $200 million to fund a new Phase 3 trial of Roluperidone and prepare for a potential U.S. launch. Find out what’s next.
How Celcuity Inc.’s gedatolisib trial results sent its stock soaring 46% in a single morning
Celcuity stock surged 46% after Phase 3 trial data showed strong efficacy for gedatolisib in HR+/HER2- breast cancer. Find out what this means for investors.
Kiniksa’s KPL-387 earns FDA orphan drug nod, advancing next-gen therapy for recurrent pericarditis
Find out how Kiniksa’s KPL-387 won FDA orphan drug status for pericarditis — and what it means for the company’s expanding rare-disease franchise.
Praxis Precision Medicines (NASDAQ: PRAX) surges 229% after breakthrough Phase 3 data in essential tremor
Praxis stock soared 229% on Phase 3 results for ulixacaltamide in essential tremor. Find out what this means for PRAX’s future and investor sentiment.
AbbVie wins FDA nod expanding RINVOQ label to Crohn’s disease in major IBD market milestone
Find out how AbbVie’s FDA approval for RINVOQ in Crohn’s disease is reshaping IBD therapy and boosting investor confidence in its post-Humira strategy.
FDA doubles down on Palvella’s QTORIN rapamycin as Phase 3 SELVA trial exceeds enrollment
Find out how the FDA’s renewed orphan grant is accelerating Palvella Therapeutics’ Phase 3 QTORIN trial toward potential approval in rare disease care.
Medtronic (NYSE: MDT) launches Embrace Gynecology study — will Hugo RAS redefine robotic hysterectomies in the U.S.?
Medtronic’s Embrace Gynecology trial tests Hugo RAS in hysterectomies—can it challenge da Vinci’s dominance and reshape women’s robotic surgery?