FDA accepts Pfizer's Supplemental New Drug Applications for BRAFTOVI + MEKTOVI
Pfizer Inc. (NYSE:PFE) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. (Source: World Pharma News)
Source: World Pharma News - April 5, 2023 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news
Thyroid Drug on Hold; FreeStyle Libre Safety Note; Levothyroxine Overprescribed?
(MedPage Today) -- The FDA "identified deficiencies" in Ascendis Pharma's new drug application for its hypoparathyroidism drug palopegteriparatide (TransCon PTH), putting new labeling and post-marketing discussions on hold for now, the developer... (Source: MedPage Today Endocrinology)
Source: MedPage Today Endocrinology - April 5, 2023 Category: Endocrinology Source Type: news
HUTCHMED Completes Rolling Submission of NDA to U.S. FDA for Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer
Hong Kong, Shanghai& Florham Park, NJ— Friday March 31, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM, HKEX:13) today announces that it completed the rolling submission of a New Drug Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 31, 2023 Category: Drugs & Pharmacology Source Type: news
Biogen Provides Update on FDA Advisory Committee Meeting on Tofersen for SOD1-ALS
CAMBRIDGE, Mass., March 22, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced today the outcome of the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee meeting on tofersen, an... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 23, 2023 Category: Drugs & Pharmacology Source Type: news
Glenmark gets USFDA nod for generic drug with 180-day exclusivity
The USFDA noted that the Mumbai-based drug firm was the first abbreviated new drug application (ANDA) applicant with a paragraph IV certification for Calcipotriene and Betamethasone Dipropionate Foam, it added. "Therefore, with this approval, Glenmark is eligible for 180 days of generic drug exclusivity for Calcipotriene and Betamethasone Dipropionate Foam," the drug firm said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - March 23, 2023 Category: Pharmaceuticals Source Type: news
AbbVie Provides Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa) New Drug Application
NORTH CHICAGO, Ill., March 22, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for ABBV-951... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 22, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Expanded Indication for Telix ’s Illuccix to Include Patient Selection for PSMA-Directed Radioligand Therapy
Indianapolis, IN (United States) | 16 March 2023 -- Telix Pharmaceuticals today announces that the United States Food and Drug Administration (FDA) has approved a supplementary New Drug Application (sNDA) for Illuccix® (kit for the preparation... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 16, 2023 Category: Drugs & Pharmacology Source Type: news
Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals
This dataset provides a listing of all New Molecular Entities (NMEs) approved from 1985 – 2019 and regulated by the Center for Drug Evaluation and Research (CDER). The listed NMEs include both small molecule drugs approved under a New Drug Application (NDA) and new biological products approved under (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 13, 2023 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Ionis Announces FDA Acceptance of New Drug Application for Eplontersen for the Treatment of Hereditary Transthyretin-Mediated Amyloid Polyneuropathy (ATTRv-PN)
35-week data included in the filing demonstrated a statistically significant and clinically meaningful change from baseline for co-primary and secondary endpoints compared to external placebo group
Eplontersen previously granted Orphan Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 7, 2023 Category: Drugs & Pharmacology Source Type: news
Avadel Pharmaceuticals Requests Final FDA Approval for Lumryz (sodium oxybate) Extended-Release Oral Suspension
DUBLIN, Ireland, March 02, 2023 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that it has submitted an amendment to the U.S. Food and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 2, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Accepts for Priority Review ADX-2191 New Drug Application for the Treatment of Primary Vitreoretinal Lymphoma
LEXINGTON, Mass.--(BUSINESS WIRE) March 2, 2023 --Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review the New Drug Application (NDA) for ADX-2191... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 2, 2023 Category: Drugs & Pharmacology Source Type: news
Janssen Submits New Drug Application to the U.S. Food and Drug Administration Seeking Approval of Niraparib and Abiraterone Acetate Dual-Action Tablet, Plus Prednisone, as a First-Line Targeted Treatment for Patients with Metastatic Castration-Resistant Prostate Cancer with BRCA Gene Mutations
RARITAN, N.J., February 28, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of niraparib in combination with abiraterone acetate, in the form of a dual-action tablet (DAT), plus prednisone, for the treatment of patients with BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). If approved, this will be the first DAT formulation available in the U.S. to patients with mCRPC with BRCA mutations, which are a type of homologous recombination repair (HRR) gene alt...
Source: Johnson and Johnson - March 1, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news
Cytokinetics Receives Complete Response Letter From FDA for New Drug Application for Omecamtiv Mecarbil
SOUTH SAN FRANCISCO, Calif., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 28, 2023 Category: Drugs & Pharmacology Source Type: news
Verrica Pharmaceuticals Announces FDA Acceptance of Filing of Resubmitted NDA for VP-102 for the Treatment of Molluscum Contagiosum
WEST CHESTER, PA– February 27, 2023 (GLOBE NEWSWIRE)– Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 27, 2023 Category: Drugs & Pharmacology Source Type: news
Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA
This guidance provides recommendations to industry on product-specific guidance (PSG) meetings between FDA and a prospective applicant preparing to submit to FDA or an applicant that has submitted to FDA an abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug and Co (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 24, 2023 Category: Drugs & Pharmacology Authors: FDA Source Type: news
