Transcript: " Research Investigational New Drug Applications – What You Need To Know "
Research Investigational New Drug Applications – What You Need To Know Podcast Transcript (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - November 4, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Transcript: "Research Investigational New Drug Applications – What You Need To Know"
Research Investigational New Drug Applications – What You Need To Know Podcast Transcript (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - November 4, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Lupin gets USFDA nod for generic oral contraceptive pill
Lupin has received tentative approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA), Drospirenone Tablets in 4 mg strength, the Mumbai-based drug maker said in a statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 4, 2022 Category: Pharmaceuticals Source Type: news
Iveric Bio Announces Submission of First Part of NDA for Rolling Review of Avacincaptad Pegol for the Treatment of Geographic Atrophy
PARSIPPANY, N.J.--(BUSINESS WIRE)--Nov. 3, 2022-- IVERIC bio, Inc. (Nasdaq: ISEE) today announced that it has submitted to the U.S. Food and Drug Administration (FDA) the first part of its New Drug Application (NDA) for rolling review of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 3, 2022 Category: Drugs & Pharmacology Source Type: news
Salvat Laboratories announces submission of New Drug Application to the U.S. FDA for Clobetasol Nanoemulsion for treating inflammation and pain after ocular surgery
Salvat Laboratories announced that it has submitted a New Drug Application (NDA) to the FDA for the approval of the first ocular corticosteroid formulated in a nanoemulsion for inflammation and pain in post-ocular surgery patients.
This submission comes after two successful phase III clinical trials conducted between 2020 and 2021. (Source: World Pharma News)
Source: World Pharma News - November 2, 2022 Category: Pharmaceuticals Tags: Featured Business Business and Industry Source Type: news
Genmab Announces Submissions of Regulatory Applications for Epcoritamab (DuoBody ®-CD3xCD20) for the Treatment of Relapsed/Refractory Large B-Cell Lymphoma (LBCL) and Diffuse Large B-Cell Lymphoma (DLBCL)
Genmab has Submitted Biologics License Application (BLA) to U.S. Food and Drug Administration (FDA) for epcoritamab
European Medicines Agency (EMA) has validated Marketing Authorization Application (MAA) for epcoritamab submitted by AbbVie
The... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 28, 2022 Category: Drugs & Pharmacology Source Type: news
Santhera and ReveraGen Complete NDA Submission to FDA for Vamorolone in Duchenne Muscular Dystrophy
Pratteln, Switzerland, and Rockville, MD, USA, October 27, 2022– Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce that they have completed the rolling submission of a new drug application (NDA) to the U.S. Food... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 27, 2022 Category: Drugs & Pharmacology Source Type: news
Gilead Receives Complete Response Letter from U.S. FDA for Bulevirtide for the Treatment of Adults with Hepatitis Delta Virus
Foster City, Calif., October 27, 2022 – The U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the Biologics License Application (BLA) for bulevirtide, an investigational entry-inhibitor for the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 27, 2022 Category: Drugs & Pharmacology Source Type: news
Alembic Pharma gets USFDA nod for generic injection to treat cancer
The approval granted by the US Food& Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Paclitaxel injection of strengths 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL) multiple-dose vials. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 27, 2022 Category: Pharmaceuticals Source Type: news
Seres Therapeutics Announces FDA Acceptance of Biologics License Application for Investigational Microbiome Therapeutic SER-109 for Recurrent C. Difficile Infection for Priority Review
If approved, SER-109 expected to be the first-ever FDA-approved oral microbiome therapeutic
PDUFA target action date is April 26, 2023, with anticipated launch soon thereafter
FDA advised that they are not currently planning to hold an Advisory... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 26, 2022 Category: Drugs & Pharmacology Source Type: news
Novaliq Announces FDA Acceptance of the New Drug Application for CyclaSol for the Treatment of Dry Eye Disease
PDUFA target action date is June 8, 2023
HEIDELBERG, Germany, and CAMBRIDGE, MA, USA, October 24, 2022– Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 24, 2022 Category: Drugs & Pharmacology Source Type: news
Biogen Announces FDA ’s 3-Month Extension of Review Period for the New Drug Application for Tofersen
The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is April 25, 2023
CAMBRIDGE, Mass., Oct. 17, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 17, 2022 Category: Drugs & Pharmacology Source Type: news
Minerva Neurosciences Receives Refusal to File Letter from FDA for its New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
BURLINGTON, Mass., Oct. 17, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 17, 2022 Category: Drugs & Pharmacology Source Type: news
Travere Therapeutics Provides Regulatory Update on its Sparsentan Program for IgA Nephropathy
SAN DIEGO, Oct. 13, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that following late-cycle review interactions with the U.S. Food and Drug Administration (FDA), the Company expects the previously assigned... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 13, 2022 Category: Drugs & Pharmacology Source Type: news
Alnylam Announces FDA Approval of Supplemental New Drug Application for Oxlumo (lumasiran) in Advanced Primary Hyperoxaluria Type 1
Oxlumo Now Indicated for the Treatment of Primary Hyperoxaluria Type 1 (PH1) to Lower Urinary and Plasma Oxalate Levels in Pediatric and Adult Patients
Approval is Based on Positive Efficacy and Safety Results of the ILLUMINATE-C Phase 3 Study of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 7, 2022 Category: Drugs & Pharmacology Source Type: news
