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Approvals

Gavreto is approved by FDA yet again.
FDA
FDA Approves MorphoSys and Incyte’s DLBCL Drug Monjuvi
Eight months after inking a collaboration deal, MorphoSys and Incyte won approval for Monjuvi for adult patients with relapsed or refractory diffuse large B-cell lymphoma.
August 3, 2020
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2 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: August 3
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 3, 2020.
August 3, 2020
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3 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 31
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 31, 2020.
July 30, 2020
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4 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 29
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 29, 2020.
July 29, 2020
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5 min read
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BioSpace Editorial Staff
Oxbryta gets greenlight for Pediatric SCD treatmen
FDA
FDA Greenlights Gilead/Kite’s Tecartus for Mantle Cell Lymphoma
The U.S. Food and Drug Administration (FDA) approved Kite Pharma’s Tecartus (brexucabtagene autoleucel) for adults with relapsed or refractory mantle cell lymphoma (MCL). Kite is a Gilead Science company.
July 24, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: July 27
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 27, 2020.
July 24, 2020
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2 min read
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BioSpace Editorial Staff
FDA
AstraZeneca Wins FDA Approval for COPD Treatment
This morning, AstraZeneca announced the approval of the triple-therapy Breztri Aerosphere as a maintenance treatment for COPD.
July 24, 2020
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2 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: July 24
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 24, 2020.
July 23, 2020
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4 min read
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Editorial Staff
FDA
Jazz Pharma Wins FDA Approval for Lower-Sodium Narcolepsy Treatment
The U.S. Food and Drug Administration (FDA) approved Xywav, the first new treatment option indicated for both cataplexy and excessive daytime sleepiness in people living with narcolepsy in more than 15 years.
July 22, 2020
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2 min read
 · 
Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: July 22
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 22, 2020.
July 21, 2020
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6 min read
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BioSpace Editorial Staff
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PRESS RELEASES
FDA
Eton Pharmaceuticals Announces FDA Approval of Cysteine Hydrochloride Injection
April 11, 2022
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2 min read
FDA
Amphastar Receives FDA Approval for Ganirelix Acetate Injection
April 8, 2022
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4 min read
FDA
Clayton Pharmaceuticals and VistaPharm (a Vertice company) Receive FDA Approval for Sucralfate Oral Suspension
April 7, 2022
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2 min read
FDA
Triastek Receives FDA IND Clearance for 3D Printed Product of Blockbuster Molecule
April 7, 2022
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2 min read
Drug Development
FDA approves Novartis Vijoice® (alpelisib) as first and only treatment for select patients with PIK3CA-Related Overgrowth Spectrum (PROS)
April 6, 2022
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13 min read
FDA
BioXcel Therapeutics Announces FDA Approval of IGALMI™ (dexmedetomidine) Sublingual Film for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder in Adults
April 6, 2022
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14 min read
FDA
Tonix Pharmaceuticals Announces IND Clearance for TNX-102 SL as a Potential Treatment for Long COVID Syndrome, Also Known as Post-Acute Sequelae of COVID-19 (PASC)
April 6, 2022
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11 min read
FDA
FDA Clears InstruSafe Instrument Protection System for Use in Sterizone® VP4 Sterilization Cycle I
April 5, 2022
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2 min read
FDA
Curium Announces FDA Approval of a Generic Version of DaTscan™ (Ioflupane I 123 Injection) in the U.S.
April 5, 2022
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5 min read
FDA
Abbott Receives FDA Approval for Aveir™ VR Leadless Pacemaker System to Treat Patients with Slow Heart Rhythms
April 4, 2022
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3 min read
FDA
Acer Therapeutics’ EDSIVO™ (celiprolol) Granted FDA Breakthrough Therapy Designation for Vascular Ehlers-Danlos Syndrome
April 4, 2022
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9 min read
FDA
GE Healthcare Receives FDA Approval of First-Ever Software to Help Automate Anesthesia Delivery and Reduce Greenhouse Gas Emissions During Surgery
April 4, 2022
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5 min read
FDA
Fractyl Health Announces FDA IDE Approval to Begin Revitalize-2 Pivotal Study Designed for Patients with Type 2 Diabetes (T2D) Who Are Not Yet on Insulin
April 4, 2022
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4 min read
FDA
Precigen Receives Fast Track Designation for PRGN-3006 UltraCAR-T® in Patients with Relapsed or Refractory Acute Myeloid Leukemia
April 4, 2022
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5 min read
FDA
TSC Alliance® Welcomes FDA Approval of Topical Treatment for Facial Angiofibromas
April 4, 2022
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2 min read
FDA
FDA approves Nobelpharma’s HYFTOR™ (sirolimus topical gel) 0.2%
April 4, 2022
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7 min read
FDA
Elite Pharmaceuticals and Praxgen Pharmaceuticals Receive FDA Approval for Generic Doxycycline
April 4, 2022
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2 min read
FDA
ValenzaBio Announces FDA Clearance of Investigational New Drug Application for VB421, an Anti-IGF-1R Monoclonal Antibody for the Treatment of Thyroid Eye Disease
March 31, 2022
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2 min read
FDA
EDWARDS MITRIS RESILIA VALVE RECEIVES FDA APPROVAL FOR MITRAL REPLACEMENT SURGERIES
March 31, 2022
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4 min read
FDA
Shockwave Medical Announces Global Launch of New Peripheral Intravascular Lithotripsy CatheterShockwave M5+ IVL Catheter Broadens Options for Treatment of Peripheral Arteries
March 31, 2022
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4 min read
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