PDUFA

FDA Action Alert: Evofem, Sanofi, Regeneron and Incyte

Approvals, Atopic Dermatitis, Cholangiocarcinoma, FDA/Regulatory, New Drug Applications, PDUFA, Pregnancy Prevention, Supplemental Biologics License Application (sBLA)

A look at the U.S. Food and Drug Administration’s drug approval review calendar.

May 26, 2020/by BioSpace

FDA Action Alert: Blueprint, Bristol Myers Squibb, Clovis and Sunovion

BRCA mutation, Blockbusters, Clinical Trial Endpoints, FDA, FDA/Regulatory, Gastrointestinal Stromal Tumors, Metastatic Castration-Resistant Prostate Cancer (mCRPC), New Drug Applications, Non-Small Cell Lung Cancer (NSCLC), OFF Episodes, PDUFA, Parkinson's Disease, Sublingual film, Supplemental Biologics License Application, Supplemental New Drug Application (sNDA), Therapeutics

Despite the COVID-19 pandemic, the U.S. Food and Drug Administration has managed to stay fairly on track in terms of evaluating new drug and supplemental new drug applications. Here is a look at what is on the schedule for the next two weeks.

May 11, 2020/by Andrew Humphreys

FDA Action Alert: Celgene, Zogenix, Heron, Intercept, IntelGenx and Rockwell

Acute Migraine, Dravet syndrome, FDA, FDA/Regulatory, New Drug Application (NDA), Non-alcoholic steatohepatitis (NASH), PDUFA, Postoperative Pain, Relapsing Multiple Sclerosis (RMS)

The U.S. Food and Drug Administration has a busy week of possible drug approvals on the regulatory agency’s calendar, including Celgene’s ozanimod for relapsing forms of multiple sclerosis.

March 23, 2020/by BioSpace

Evoke Pharma Enters Commercialization Agreement with EVERSANA for Gimoti

Business, Diabetic Gastroparesis, Distribution, FDA, Life Sciences, Marketing & Advertising, Marketing communications, Multichannel marketing, Nasal Sprays, PDUFA

The collaboration will utilize EVERSANA’s integrated suite of outsourced services to commercialize and distribute Evoke Pharma Inc.’s Gimoti in the United States.

January 23, 2020/by Administrator

Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-105

Accepted NDA, FDA, Generalized Seizures, Lennox-Gastaut Syndrome (LGS), New Drug Applications, PDUFA, Partial Seizures, Primary Generalized Tonic-Clonic Seizures

Eton Pharmaceuticals Inc. announced that Aucta Pharmaceuticals Inc.’s New Drug Application for ET-105, an innovative formulation of lamotrigine which Eton acquired the U.S. marketing rights to in June 2019, was accepted for review by the U.S. Food and Drug Administration.

August 1, 2019/by GlobeNewswire

FDA Advisory Committee Cancels Review of Intra-Cellular’s Schizophrenia Drug

Advisory Panels, Clinical Data, FDA, FDA/Regulatory, New Drug Application (NDA), PDUFA, Psychopharmacologic Drugs Advisory Committee, Schizophrenia

Intra-Cellular Therapies shares fell after the company announced that the FDA canceled the advisory committee meeting to discuss the New Drug Application for the schizophrenia drug lumateperone.

July 24, 2019/by BioSpace

New Phase 3 Interim Results Support Safety and Efficacy of Diroximel Fumarate in Multiple Sclerosis

Clinical Trials, Data, FDA, Multiple Sclerosis, PDUFA, R&D, Relapsing Multiple Sclerosis (RMS), Triple-Combination Therapies

New interim data from the ongoing open-label, pivotal EVOLVE-MS-1 study indicate that Biogen’s investigational treatment diroximel fumarate was generally well tolerated in people with relapsing MS.

May 30, 2019/by GlobeNewswire

Nektar Forms New Subsidiary

Business, Chronic Lower Back Pain (cLBP), Company Launches, FDA, New Drug Applications, Opioids, PDUFA, Pain

With an opioid molecule awaiting regulatory review, Nektar Therapeutics announced the launch of Inheris Biopharma, which will be responsible for the commercialization of NKTR-181.

May 24, 2019/by BioSpace

Kala Pharmaceuticals’s NDA for KPI-121 0.25% for Dry Eye Disease Accepted for FDA Review

Dry Eye Disease, FDA, FDA/Regulatory, New Drug Applications, PDUFA

Kala Pharmaceuticals Inc. announced that the New Drug Application (NDA) for KPI-121 0.25%, a product candidate for the temporary relief of signs and symptoms of dry eye disease utilizing a two-week course of therapy, has been accepted for review by the United States Food and Drug Administration FDA.

December 27, 2018/by Business Wire

Acer Therapeutics Announces FDA Acceptance of NDA and Priority Review for Edsivo for Treatment of vEDS

Ehlers-Danlos Syndrome (EDS), FDA, FDA/Regulatory, Hereditary Disorders, Mutations, New Drug Application (NDA), PDUFA, Priority Review, Vascular Ehlers-Danlos Syndrome (EDS)

The U.S. Food and Drug Administration accepted for review Acer Therapeutics Inc.’s New Drug Application for Edsivo for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen mutation.

December 26, 2018/by GlobeNewswire