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FDA Approvals News LIVE

Our live feed is dedicated to bringing you the most recent and important FDA approvals in the pharmaceutical and biotech sectors. Witness the effect these crucial decisions have on the stock market as they occur.

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ARDX : Nasdaq
FDA Approves XPHOZAH® (tenapanor), a First-in-Class Phosphate Absorption Inhibitor
fda approval
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UCBJY : OTC
UCB announces U.S. FDA approval of ZILBRYSQ® (zilucoplan) for the treatment of adults with generalized myasthenia gravis
fda approval
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MRK : NYSE
FDA Approves KEYTRUDA® (pembrolizumab) for Treatment of Patients With Resectable (T≥4 cm or N+) NSCLC in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as a Single Agent as Adjuvant Treatment After Surgery
fda approval
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PFE : NYSE
Everest Medicines' Licensing Partner Pfizer Announces U.S. FDA Approves Etrasimod for Adults with Moderately to Severely Active Ulcerative Colitis
fda approval
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BMY : NYSE
U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as Adjuvant Treatment for Eligible Patients with Completely Resected Stage IIB or Stage IIC Melanoma¹
fda approval
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PFE : NYSE
U.S. FDA Approves Pfizer’s VELSIPITY™ for Adults with Moderately to Severely Active Ulcerative Colitis (UC)
fda approval
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ENDV : OTC
Endonovo's SofPulse® Secures Taiwan FDA Approval
fda approval
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PFE : NYSE
U.S. FDA Approves Pfizer’s BRAFTOVI® + MEKTOVI® for BRAF V600E-Mutant Metastatic Non-Small Cell Lung Cancer
fda approval
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BFRI : Nasdaq
Biofrontera Inc. Receives FDA Approval for New Formulation of Ameluz(R)
fda approval
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ARQT : Nasdaq
FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for Treatment of Psoriasis in Children Ages 6 to 11
fda approval
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APLS : Nasdaq
Apellis Announces U.S. FDA Approval of the EMPAVELI® Injector, a Device to Streamline Self-Administration
fda approval
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ANIP : Nasdaq
ANI Pharmaceuticals Announces FDA Approval and Commercial Availability of New 1-mL Vial Size of Purified Cortrophin® Gel, Appropriate for Adjunctive Treatment of Certain Patients with Acute Gouty Arthritis Flares
fda approval
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WXXWY : OTC FOLD : Nasdaq
WuXi Biologics Congratulates Amicus Therapeutics on U.S. FDA Approval for New Treatment for Pompe Disease
fda approval
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BIIB : Nasdaq
FDA Approves Biogen’s TOFIDENCE™ (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA®
fda approval
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FOLD : Nasdaq
Amicus Therapeutics Announces FDA Approval and Launch of New Treatment for Pompe Disease
fda approval
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VAPO : NYSE
The FDA Approves IDE for ReGelTec’s Pivotal Study of HYDRAFIL® for Chronic Low Back Pain due to Degenerative Disc Disease
fda approval
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PRTC : Nasdaq KRTX : Nasdaq
KarXT, invented at PureTech, submitted for FDA Approval in Schizophrenia
fda approval
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TAK : NYSE
U.S. FDA Approves Subcutaneous Administration of Takeda's ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis
fda approval
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EVFM : OTC
Evofem Announces Padagis Will Not Seek FDA Approval to Market a Generic Version of Phexxi® Until Evofem's Phexxi Patents Expire
fda approval
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OCUP : Nasdaq
Ocuphire Pharma and Viatris Announce FDA Approval of RYZUMVI™ (Phentolamine Ophthalmic Solution) 0.75% Eye Drops for the Treatment of Pharmacologically-Induced Mydriasis Produced by Adrenergic Agonists (e.g., Phenylephrine) or Parasympatholytic (e.g., Tropicamide) Agents
fda approval
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ZIMV : Nasdaq
ZimVie Announces FDA Approval to Launch Mobi-C® Hybrid Study
fda approval
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APLIF : OTC
Appili Therapeutics Announces U.S. FDA Approval of LIKMEZ™ (ATI-1501) Metronidazole Oral Suspension
fda approval
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LLY : NYSE
US FDA approves Jardiance® for the treatment of adults with chronic kidney disease
fda approval
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IMMX : Nasdaq
U.S. Food and Drug Administration Approves Orphan Drug Designation for Immix Biopharma NXC-201 as a Treatment for Amyloid Light Chain (AL) Amyloidosis
clinical trial fda approval
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OBIO : Nasdaq
Orchestra BioMed Granted FDA Approval of IDE to Initiate BACKBEAT Pivotal Study of BackBeat CNT™ for the Treatment of Hypertension in Pacemaker Patients
fda approval
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Today's News - Full List