Browsing Tag
United States Food and Drug Administration
193 posts
Could Ebglyss’ longer dosing window strengthen Eli Lilly and Company’s dermatology growth strategy?
Find out how Ebglyss’ every-eight-week FDA approval could strengthen Eli Lilly’s dermatology strategy and investor sentiment.
Can Dabur India contain the USFDA import alert before it hurts investor confidence?
Dabur says the USFDA import alert has no impact, but investor trust now depends on how fast the company fixes the quality gaps. Read more.
Why Cipla’s Goa facility VAI status matters more than a routine USFDA inspection update
Cipla has regulatory breathing room, but launches still matter. The Goa VAI status may decide how investors price its US growth story. Read more.
$IMU rises after Imugene wins FDA Fast Track status for allogeneic CAR T therapy in CLL and MZL
Imugene won FDA Fast Track status for azer-cel in blood cancers. Find out what the $IMU regulatory boost means for investors.
Why the THIO-104 Phase 3 trial could become the most important milestone in MAIA Biotechnology’s history
Find out how MAIA Biotechnology’s ateganosine trial progress could reshape its lung cancer strategy and investor sentiment.
Could pediatric diabetes demand unlock new commercial momentum for MannKind Corporation’s Afrezza?
Find out how Afrezza’s pediatric FDA approval could strengthen MannKind’s growth story and reshape investor sentiment today.
Lupin and Natco FDA approval puts #LUPIN in focus as oncology generic pipeline strengthens
Lupin and Natco won FDA approval for Eribulin generic. #LUPIN investors now face the real test: launch timing and U.S. pricing.
Amplia Therapeutics (ASX: ATX) stock faces its next big test as narmafotinib moves deeper into cancer trials
Find out how Amplia Therapeutics’ FY2026 report frames ASX: ATX, narmafotinib trials, cash runway and investor sentiment today!
Wockhardt wins FDA approval for Zaynich as #WOCKPHARMA nears 52-week high
Wockhardt Limited’s Zaynich FDA approval could reshape its antibiotic pipeline story. Find out what it means for investors and Indian pharma.
CellCarta and Sonic Healthcare USA partnership puts companion diagnostics commercialization in focus
CellCarta and Sonic Healthcare USA target companion diagnostics commercialization. Find out why this lab network deal matters for precision medicine.