FDA Approval

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FDA Approval Recent News

Spectrum Gets FDA Nod For Febrile Neutropenia Candidate, Sees Commercial Launch In Q4 2022
The U.S. Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ (NASDAQ: SPPI) lead asset ROLVEDON (eflapegrastim-xnst) injection to decrease the incidence of infection, as manifested by febrile neutropenia.
Revance Shares Shoot Higher As FDA Cleared DAXXIFY Injection For Frown Lines
The United States Food and Drug Administration (FDA) has approved Revance Therapeutics’ (NASDAQ: RVNC) lead asset DAXXIFY (DaxibotulinumtoxinA-lanm) for injection for the temporary improvement of moderate to severecfrown lines (glabellar lines) in adults.
Sanofi's Rare Disease Drug Xenpozyme Scores FDA Approval
Incyte Gets FDA Nod For Hematologic Malignancies Candidate
The U.S. Food and Drug Administration (FDA) has approved Incyte’s (NASDAQ: INCY) Pemazyre (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.
Axsome Shares Shoot Higher As FDA Approves Major Depressive Disorder Candidate
The U.S. Food and Drug Administration (FDA) has approved Axsome Therapeutics’ (NASDAQ: AXSM) lead asset AUVELITY (dextromethorphan HBr -bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults.
Bluebird Secures FDA Nod For Genetic Blood Disease Candidate
The U.S. Food and Drug Administration (FDA) has approved Bluebird bio’s (NASDAQ: BLUE) lead asset ZYNTEGLO (betibeglogene autotemcel) to treat the underlying genetic cause of beta‑thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions.
Arcutis Gets FDA Nod For Plaque Psoriasis Candidate, Sees Commercial Launch In Mid-August
The U.S. Food and Drug Administration (FDA) has approved Arcutis Biotherapeutics’ (NASDAQ: ARQT) New Drug Application (NDA) for ZORYVE (roflumilast) cream 0.3% for the treatment of plaque psoriasis in patients 12 years of age or older.
Horizon Therapeutics Receives FDA Approval For Uncontrolled Gout Candidate
The U.S. Food and Drug Administration (FDA) has approved Horizon Therapeutics’ (NASDAQ: HZNP) supplemental Biologics License Application (sBLA) for expanding the labeling to include KRYSTEXXA (pegloticase) injection co-administered with methotrexate, in patients with uncontrolled gout.
FDA Green Lights Ceruvia's Phase 2 Psilocybin Trial Program For Obsessive-Compulsive Disorder Treatment
Clinical-stage biopharma company Ceruvia Lifesciences recently received FDA  approval for its Investigational New Drug (IND) application for a Phase 2 clinical trial to determine the efficacy and safety of proprietary synthetic psilocybin (SYNP-101) in treating obsessive-compulsive disorder (OCD).&nbs
Cybin's Psilocybin Analog CYB003 Gets FDA Clearance For Trial To Potentially Treat Major Depressive Disorder
Psychedelic biopharma company Cybin Inc. (NEO: CYBN) has received FDA  Investigational New Drug Application (IND) approval for a Phase 1/2a clinical trial evaluating its proprietary CYB003 for treating major depressive disorder (MDD).
Rhythm Pharmaceuticals' Shares Dive Following FDA's Verdict On IMCIVREE Drug
The U.S. Food and Drug Administration (FDA) has approved Rhythm Pharmaceuticals’ (NASDAQ: RYTM) supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide), a melanocortin-4 receptor (MC4R) agonist, for patients with Bardet-Biedl syndrome (BBS).
U.S. FDA Approves Regeneron And Sanofi's Lead Drug For Skin Inflammation In Children
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Major Depressive Disorder Could Soon Have Treatment Option Via Cybin's Psilocybin Analog
Cybin Inc. (CYBN), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics," has submitted an Investigational New Drug (or “IND”) application to the FDA.
High Hopes For Alcohol Use Disorder Treatment: Clearmind's Successful Pre-IND Meeting With The FDA
The meeting, which took place on May 18 between the psychedelic pharmaceutical biotech company Clearmind Medicine Inc. (CMNDF) and the US Food and Drug Administration marks the completion the pre-IND New Drug Application stage.
Psychedelics Biotech Companies Mark New Milestones In Drug Development Pipelines: Field Trip, Cybin and Wesana
On Tuesday, three public companies in the psychedelics/biotech space announced significant milestones in their drug development pipelines.
Boston Scientific's Exalt Model B Single-Use Bronchoscope Wins FDA Approval
DURECT Sahres Soar After FDA Nod For Post-Surgical Pain Medication Posimir
The Week Ahead In Biotech: Avenue's FDA Decision, Alkermes Adcom Meeting, Aziyo Biologics IPO
Biotech stocks made a steady recovery over the week ended Oct. 2, although Friday's weakness trimmed some of the gains of the week.
Regulators Approve GW Pharmaceuticals' Cannabis-based Epidyolex In Australia
Epidyolex, the first FDA approved CBD medicine for severe epilepsy in children, received Australian Therapeutic Goods Administration approval.
FDA Issues Draft Guidance To Encourage Cannabis Clinical Research
The U.S. Food and Drug Administration has issued a nine-page document to lead and encourage cannabis research.
Thermo Fisher Ships First Batch Of Coronavirus Tests, Plans To Produce 5M Tests A Week By April
Roche Receives FDA Emergency Approval To Ship 400,000 Coronavirus Test Kits Across US
Epizyme's Tazemetostat Drug For Epithelioid Sarcoma Gets Accelerated FDA Approval