Galderma Announces Regulatory Filing Acceptance for Nemolizumab in Prurigo Nodularis and Atopic Dermatitis in the U.S. and EU
Zug, Switzerland– February 14, 2024– Galderma today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Applications for nemolizumab for the treatment of prurigo nodularis and for adolescents... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 14, 2024 Category: Drugs & Pharmacology Source Type: news

Ipsen ’s Onivyde Regimen, a Potential New Standard-of-Care First-Line Therapy in Metastatic Pancreatic Adenocarcinoma, Approved by FDA
PARIS, FRANCE, 13 February 2024– Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde (irinotecan liposome injection) plus... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 13, 2024 Category: Drugs & Pharmacology Source Type: news

Citius Pharmaceuticals Resubmits the Biologics License Application of Lymphir (denileukin diftitox) for the Treatment of Adults With Relapsed or Refractory Cutaneous T-Cell Lymphoma
CRANFORD, N.J., Feb. 13, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ( " Citius " or the " Company " ) (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 13, 2024 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Xspray Pharma ’s NDA-Resubmission for Dasynoc
Stockholm, Sweden– 2024-02-12 Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY): The U.S. Food and Drug Administration (FDA) has accepted the resubmission of Xspray Pharma’s New Drug Application (NDA) for Dasynoc®, following a... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 12, 2024 Category: Drugs & Pharmacology Source Type: news

Lykos Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for MDMA-Assisted Therapy for PTSD
SAN JOSE, Calif., Feb. 9, 2024 /PRNewswire/ -- Lykos Therapeutics (formerly MAPS Public Benefit Corporation) ( " Lykos " ), a company dedicated to transforming mental healthcare, announced that the U.S. Food and Drug Administration ( " FDA " ) has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 9, 2024 Category: Drugs & Pharmacology Source Type: news

Amneal Announces Complete Response Resubmission for IPX203 New Drug Application
BRIDGEWATER, N.J., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the“Company”) today announced that it has provided a Complete Response resubmission to the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 8, 2024 Category: Drugs & Pharmacology Source Type: news

Bridgebio Pharma Announces U.S. Food and Drug Administration (FDA) Acceptance of New Drug Application (NDA) for Acoramidis for the Treatment of Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Accepted with Prescription Drug User Fee Act (PDUFA) action date of November 29, 2024; FDA not currently planning to hold an advisory committee meeting to discuss application Marketing Authorization Application accepted by the European Medicines... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 5, 2024 Category: Drugs & Pharmacology Source Type: news

Defender Pharmaceuticals Receives Complete Response Letter from the U.S. Food and Drug Administration for its Intranasal Scopolamine (DPI-386) New Drug Application for the Prevention of Nausea and Vomiting Induced by Motion in Adults
ST. LOUIS, MO—(BUSINESS WIRE)—Jan. 30, 2024—Defender Pharmaceuticals, Inc. (the“Company” or“Defender”), a privately held life sciences company based in St. Louis, today announced that the U.S. Food and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 30, 2024 Category: Drugs & Pharmacology Source Type: news

Liquidia Corporation Provides Update on New Drug Application for Yutrepia (treprostinil) inhalation powder
MORRISVILLE, N.C., Jan. 25, 2024 (GLOBE NEWSWIRE) -- Liquidia Corporation (the Company) (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) provided an update on its review of the New Drug Application (NDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 25, 2024 Category: Drugs & Pharmacology Source Type: news

Heron Therapeutics' Non-Opioid, Post-Operative Pain Drug Approved For Use In Additional Orthopedic, Soft Tissue Procedures - FDA Gives Nod
The FDA has approved Heron Therapeutics Inc’s HRTX supplemental New Drug Application for Zynrelef (bupivacaine and meloxicam) extended-release solution to expand the indication for soft tissue and orthopedic surgical procedures, including foot and ankle, and other procedures in which direct…#fda #zynrelef #heron #crosslink #vialaccessneedle #craigcollard #nda #hrtx (Source: Reuters: Health)
Source: Reuters: Health - January 24, 2024 Category: Consumer Health News Source Type: news

Heron Therapeutics Announces FDA Approval of Zynrelef Indication Expansion to Include Additional Orthopedic and Soft Tissue Procedures
SAN DIEGO, Jan. 23, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (the " FDA " ) has approved its supplemental New Drug Application... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 23, 2024 Category: Drugs & Pharmacology Source Type: news

Former 49ers linebacker joins new team entering playoffs for ALS drug
Neuvivo hopes to file a new drug application with the Food and Drug Administration — asking the regulator to approve its ALS drug — this year. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - January 22, 2024 Category: Pharmaceuticals Authors: Ron Leuty Source Type: news

FDA Issues Complete Response Letter for Satsuma ’s STS101
TOKYO and KAGOSHIMA, Japan, January 18, 2024– Shin Nippon Biomedical Laboratories, Ltd. (TSE Prime: 2395, Chairman and President: Ryoichi Nagata, M.D., Ph.D.,“SNBL”) announced today that its wholly-owned US subsidiary, Satsuma... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 18, 2024 Category: Drugs & Pharmacology Source Type: news

FDA Acceptance of Zevra's Arimoclomol NDA Filing for Niemann-Pick Disease Type C (NPC) Results in XOMA Making a $1 Million Milestone Payment to LadRx
EMERYVILLE, Calif., Jan. 11, 2024 (GLOBE NEWSWIRE) -- XOMA Corporation XOMA, the biotech royalty aggregator, announced today that based upon the U.S. Food and Drug Administration's (FDA) acceptance of Zevra Therapeutics' New Drug Application (NDA) for arimoclomol, an orally-delivered,…#emeryville #xomacorporationxoma #fda #nda #npc #xoma #ladrx #arimoclomol #bradsitko #zevra (Source: Reuters: Health)
Source: Reuters: Health - January 11, 2024 Category: Consumer Health News Source Type: news

Requests for Reconsideration at the Division Level Under GDUFA
This draft guidance provides recommendations on the procedures for applicants of abbreviated new drug applications (ANDAs) that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 10, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news