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Approvals

FDA
FDA Grants Sunovion’s Latuda Expanded Approval for Bipolar Depression in Pediatric Patients
There is a newly approved treatment for pediatric patients with major depressing episodes associated with bipolar disorder.
March 6, 2018
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2 min read
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Alex Keown
FDA
FDA Approves 23andMe’s Direct-to-Consumer Genetic Test for Cancer
The U.S. Food and Drug Administration (FDA) approved the first-ever direct-to-consumer genetic test for cancer risk.
March 6, 2018
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3 min read
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Mark Terry
FDA
FDA Expands Bristol-Myers Squibb’s Opdivo Dosing Schedule
The U.S. Food and Drug Administration (FDA) expanded the dosing schedule for Bristol-Myers Squibb’s Opdivo (nivolumab).
March 6, 2018
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2 min read
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Mark Terry
FDA
Prometic Snags Rare Pediatric Disease Designation from the FDA for its Inter-Alpha-Inhibitor-Proteins
Shares of Prometic Life Sciences Inc. jumped this morning after securing the U.S. Food and Drug Administration’s Rare Pediatric Disease Designation.
March 5, 2018
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2 min read
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Alex Keown
FDA
FDA Issues New Draft Guidance for Alzheimer’s Trials that Could Open Up Approvals
The U.S. Food and Drug Administration (FDA) issued new draft guidance for preclinical trials in Alzheimer’s.
March 2, 2018
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3 min read
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Mark Terry
Drug Development
Sanofi and Regeneron Seek FDA Approval of Dupixent as Add-On Asthma Therapy
Asthma patients may soon have a new treatment option.
March 2, 2018
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2 min read
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Alex Keown
FDA
Sorrento Nabs FDA Approval for Shingles Pain Patch That Could Hit Blockbuster Status
Sorrento Therapeutics, Inc. nabbed regulatory approval for ZTlido, a non-opioid pain treatment in the form of a super-sticky patch.
March 1, 2018
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2 min read
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Alex Keown
Drug Development
Portola Plunges After Hint of Delay for FDA Approval of Factor Xa-inhibitor
Shares of Portola Pharmaceuticals are falling after the company announced a delay of several months for possible regulatory approval of its Factor Xa-inhibitor antidote, AndexXa.
March 1, 2018
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2 min read
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Alex Keown
$710M Gamble Fails as Celgene Terminates Two Phase
Drug Development
FDA Stuns Celgene With Refusal to File Letter for MS Treatment Ozanimod
The U.S. Food and Drug Administration stunned the company with a Refusal to File letter regarding its New Drug Application (NDA) for multiple sclerosis treatment ozanimod.
February 28, 2018
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2 min read
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Alex Keown
FDA
FDA Grants Yisheng Biopharma’s Clinical Treatment its Second Orphan Drug Designation
Beijing-based Yisheng Biopharma Co. is celebrating this morning after its lead immunology treatment snagged a second Orphan Drug Designation from the U.S. Food and Drug Administration.
February 26, 2018
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2 min read
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Alex Keown
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PRESS RELEASES
FDA
FDA Approves Novadoz Pharmaceuticals Toremifene and Aminocaproic Acid, Bolstering their Continued Growth in Generics
December 10, 2020
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2 min read
FDA
Viveve Announces FDA Approval of Proposed Amendments to Pivotal U.S. PURSUIT Trial Protocol
December 10, 2020
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5 min read
FDA
Entera Bio Announces FDA Approval of IND Application for EB613 – an Oral Human Parathyroid Hormone (1-34) for the Treatment of Osteoporosis
December 10, 2020
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9 min read
FDA
Atox Bio Announces FDA Acceptance to File the NDA for Reltecimod to Treat Suspected Organ Dysfunction or Failure in Patients with Necrotizing Soft Tissue Infection (“Flesh-Eating Disease”)
December 10, 2020
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4 min read
FDA
Advanced Bionics Receives FDA Approval for Marvel Cochlear Implant Platform and World’s First Sound Processor for Children
December 10, 2020
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8 min read
FDA
TVAX Biomedical announces major advancements in potential Glioblastoma cure
December 9, 2020
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2 min read
FDA
VOLTA MEDICAL’s VX1 AI software for use in atrial fibrillation mapping now FDA cleared
December 9, 2020
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5 min read
FDA
Carlsmed aprevo™ Granted Unprecedented Decision by FDA
December 8, 2020
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3 min read
FDA
Turning Point Therapeutics Granted FDA Breakthrough Therapy Designation for Repotrectinib Treatment in Patients with ROS1-Positive Metastatic Non-Small Cell Lung Cancer
December 8, 2020
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5 min read
FDA
Cerecor Announces FDA Acceptance of Investigational New Drug Application for CERC-007 for Treatment of Relapsed or Refractory Multiple Myeloma
December 8, 2020
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5 min read
FDA
Rheonix COVID-19™ MDx Assay Receives Expanded FDA Emergency Use Authorization to Include Saliva as a Sample Type
December 7, 2020
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3 min read
FDA
FDA approves Saxenda® for the treatment of obesity in adolescents aged 12-17
December 4, 2020
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14 min read
FDA
BioCryst Announces FDA Approval of ORLADEYO™ (berotralstat), First Oral, Once-daily Therapy to Prevent Attacks in Hereditary Angioedema Patients
December 3, 2020
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9 min read
FDA
US FDA Approves Guerbet’s Optiray® (Ioversol Injection) Imaging Bulk Package
December 3, 2020
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6 min read
FDA
Viveve Announces FDA 510K Approval to Expand Manufacturing of Treatment Tips
December 3, 2020
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4 min read
FDA
Eyenovia Announces FDA Acceptance of IND for MicroLine for Presbyopia, Clearing Path to Initiate Phase 3 VISION Trial by Year End
December 3, 2020
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5 min read
FDA
Etiometry’s Platform for Clinical Decision Support Software Earns 6th FDA Clearance
December 2, 2020
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3 min read
Drug Development
Catalyst Biosciences Receives FDA Fast Track Designation for Subcutaneous MarzAA for the Treatment of Episodic Bleeding in Hemophilia A or B with Inhibitors
December 2, 2020
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3 min read
FDA
Protagonist’s Hepcidin Mimetic Candidate PTG-300 Receives Fast Track Designation from the U.S. Food and Drug Administration for Development in the Treatment of Polycythemia Vera
December 2, 2020
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5 min read
FDA
Genentech Announces FDA Approval of Gavreto (pralsetinib) for People With Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancers
December 1, 2020
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9 min read
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