Browsing Tag
United States Food and Drug Administration
193 posts
FDA Complete Response Letter puts Disc Medicine Inc.’s bitopertin timeline under pressure
Disc Medicine Inc. shares plunge after the FDA issues a Complete Response Letter for bitopertin. Find out what this setback means for investors and strategy.
Zydus Lifesciences (NSE: Zyduslife) secures FDA approval for ammonium lactate cream as U.S. generics execution deepens
Zydus Lifesciences Limited secures USFDA approval for ammonium lactate cream. Find out why this modest launch matters for U.S. generics strategy.
Nektar Therapeutics (NASDAQ: NKTR) raises $460m as rezpegaldesleukin data strengthens Phase 3 autoimmune outlook
Nektar Therapeutics raised $460 million after strong rezpegaldesleukin data. Find out what this means for Phase 3 trials and autoimmune drug markets.
Lunai Bioworks (NASDAQ: LNAI) tests whether AI-driven patient stratification can de-risk oncology trials
Find out how Lunai Bioworks Inc. is using AI to uncover hidden survival signals in oncology trials and what it could mean for future FDA approvals.
Neurophet bags third FDA 510(k) clearance as AI imaging tools move closer to frontline Alzheimer’s care decisions
Neurophet wins FDA clearance for AQUA AD Plus, strengthening its U.S. strategy as AI imaging becomes central to Alzheimer’s treatment decisions. Read more.
Imricor Medical (ASX: IMR) moves closer to US market with Advantage-MR regulatory filing
Imricor Medical Systems has filed Advantage-MR for FDA 510(k) clearance. Find out how this could reshape MRI-guided cardiac ablation workflows.
Why did the FDA double down on rejecting Corcept’s flagship drug? Investors rattled
Corcept Therapeutics faces fresh regulatory headwinds as the FDA revises its relacorilant rejection letter, highlighting safety concerns and strategic missteps. Read more.
Ateganosine Phase 3 marks inflection point for MAIA Biotechnology with 2026 milestones in focus
Find out how MAIA Biotechnology’s Phase 3 ateganosine trial and 2026 milestones could reshape its regulatory path and investor narrative.
Can Bluebird Botanicals help cbdMD reclaim leadership in the evolving wellness market?
cbdMD acquires Bluebird Botanicals to expand IP, unify brands, and boost 2026 profitability. Find out how this move reshapes the cannabinoid wellness market.
Abbisko Therapeutics’ pimicotinib clears FDA filing hurdle: Why this matters for rare tumor strategy and global biotech credibility
Abbisko Therapeutics clears a key FDA hurdle for pimicotinib. Find out why this TGCT filing could reshape rare tumor strategy and global biotech credibility.