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Approvals

FDA
Merck’s Keytruda Approved for First-Line Treatment of Colorectal Cancer
The anti-PD-1 therapy was approved by the U.S. Food and Drug Administration alone for first-line treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
June 30, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: June 29
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 29, 2020.
June 29, 2020
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2 min read
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BioSpace Editorial Staff
Abicipar pegol rejected by FDA
FDA
Allergan/AbbVie’s Macular Degeneration Drug Abicipar Pegol Rejected by FDA
The U.S. Food and Drug Administration issued a Complete Response Letter, a rejection, of Allergan’s Biologics License Application for Abicipar pegol for neovascular age-related macular degeneration.
June 26, 2020
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3 min read
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Mark Terry
FDA
Zogenix Wins Approval for Dravet Syndrome Treatment Fintepla
Shares of Zogenix were up more than 16% in premarket trading following the regulatory approval of the epilepsy drug Fintepla for the treatment of seizures associated with Dravet syndrome, a rare form of epilepsy, in patients ages two and above.
June 26, 2020
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2 min read
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Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: June 26
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 26, 2020.
June 25, 2020
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3 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: June 24
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 24, 2020.
June 23, 2020
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4 min read
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BioSpace Editorial Staff
FDA
Karyopharm’s Xpovio Wins Second FDA Approval for DLBCL Treatment
The U.S. Food and Drug Administration greenlit Karyopharm Therapeutics’ Xpovio (selinexor) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) under accelerated approval.
June 23, 2020
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2 min read
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Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: June 22
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 22, 2020.
June 22, 2020
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3 min read
 · 
BioSpace Editorial Staff
FDA
FDA Approves Bone-Softening Disorder Treatment Crysvita
Crysvita is a drug developed by Ultragenyx Pharmaceutical and Tokyo-based Kyowa Kirin Co. Ltd., a specialty pharmaceutical company.
June 19, 2020
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2 min read
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Alex Keown
FDA has finally approved tavneos for ANCA Vasculit
FDA
Epizyme’s Tazverik Picks Up Its Second FDA Approval of 2020
The FDA approved a supplemental New Drug Application for Tazverik (tazemetostat) for the treatment of two distinct follicular lymphoma (FL) indications.
June 19, 2020
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2 min read
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Alex Keown
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PRESS RELEASES
FDA
AOTI Receives China FDA Approval for Topical Wound Oxygen (TWO2) Therapy Providing Renewed Hope for World’s Largest Diabetic Foot Ulcer Population
March 23, 2022
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3 min read
FDA
Berkshire Sterile achieves its first commercial drug approval by the FDA
March 22, 2022
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2 min read
FDA
FDA Approves First LAG 3 Inhibitor Antibody Opdualag For Metastatic Melanoma
March 22, 2022
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4 min read
FDA
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Patients With MSI‑H/dMMR Advanced Endometrial Carcinoma
March 21, 2022
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68 min read
FDA
PADAGIS ANNOUNCES THE FDA APPROVAL AND LAUNCH OF AN AB RATED GENERIC VERSION OF TOBRADEX® OPHTHALMIC SUSPENSION
March 21, 2022
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1 min read
FDA
NeuroSense Therapeutics Receives FDA Clearance of IND for PrimeC for the Treatment of ALS
March 21, 2022
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5 min read
FDA
ORYZON Announces FDA Approval of IND for FRIDA, a Phase Ib Trial With Iadademstat in R/R AML FLT3mut+ Patients
March 21, 2022
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7 min read
FDA
Melanoma Research Alliance Statement on FDA Approval of Relatlimab + Nivolumab for Treatment of Advanced Melanoma
March 18, 2022
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1 min read
FDA
U.S. Food and Drug Administration Approves First LAG-3-Blocking Antibody Combination, Opdualag™ (nivolumab and relatlimab-rmbw), as Treatment for Patients with Unresectable or Metastatic Melanoma
March 18, 2022
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37 min read
FDA
Marinus Pharmaceuticals Announces FDA Approval of ZTALMY® (ganaxolone) for CDKL5 Deficiency Disorder
March 18, 2022
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12 min read
FDA
PERRIGO ANNOUNCES U.S. FDA APPROVAL FOR OTC USE OF NASONEX® 24HR ALLERGY
March 17, 2022
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5 min read
FDA
Amolyt Pharma Announces US IND Clearance for the Ongoing Clinical Trial of AZP-3601 in Patients with Hypoparathyroidism
March 17, 2022
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3 min read
FDA
TC BioPharm Announces FDA Orphan Drug Status Granted for OmnImmune®
March 17, 2022
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3 min read
FDA
Aquestive Therapeutics Receives FDA Fast Track Designation for AQST-109 for Emergency Treatment of Allergic Reactions Including Anaphylaxis
March 17, 2022
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8 min read
FDA
U.S. FDA Approves FoundationOne®CDx as a Companion Diagnostic for EGFR Therapeutics Targeting Exon 19 Deletions or Exon 21 Substitutions in Non-Small Cell Lung Cancer
March 17, 2022
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4 min read
FDA
RINVOQ® (upadacitinib) Receives FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis
March 16, 2022
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22 min read
Business
Viatris Inc. Announces Receipt of the First FDA Approval for Generic Version of Symbicort® Inhalation Aerosol, Breyna™ (Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol), in Partnership with Kindeva
March 16, 2022
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7 min read
FDA
Sonnet BioTherapeutics Announces FDA Clearance of Its IND for SON-1010 for the Treatment of Advanced Solid Tumors
March 16, 2022
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4 min read
FDA
Orthofix Announces FDA Clearance and First Patient Cases With the TrueLok EVO Ring Fixation System
March 16, 2022
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6 min read
FDA
FDA Approves First Generic of Symbicort to Treat Asthma and COPD
March 15, 2022
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4 min read
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