Amneal Receives U.S. FDA Complete Response Letter for IPX203
BRIDGEWATER, N.J.--(BUSINESS WIRE) July 03, 2023 --Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the“Company”) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 3, 2023 Category: Drugs & Pharmacology Source Type: news

Madrigal Pharmaceuticals Announces Rolling Submission of New Drug Application to U.S. FDA Seeking Accelerated Approval of Resmetirom for the Treatment of NASH with Liver Fibrosis
CONSHOHOCKEN, Pa., June 30, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), initiated a rolling submission of a... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 30, 2023 Category: Drugs & Pharmacology Source Type: news

Italfarmaco Group Completes FDA Submission of New Drug Application for Givinostat in Duchenne Muscular Dystrophy and Receives Priority Review
MILAN, June 29, 2023--(BUSINESS WIRE)--Italfarmaco Group announced today that the U.S. Food and Drug Administration (FDA) has completed its filing review and accepted the company’s New Drug Application (NDA) for Givinostat. Givinostat is the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 29, 2023 Category: Drugs & Pharmacology Source Type: news

Ketamine News: PharmaTher Begins FDA Filing For KETARX Application, Stella Acquires Field Trip Assets
Specialty biotech company PharmaTher Holdings Ltd. PHRRF has filed a pre-submission facility correspondence in advance of its Abbreviated New Drug Application (ANDA) for its novel racemic ketamine KETARX to the FDA. The filing of the pre-submission correspondence is expected to help achieve an…#phrrf #ketarx #fda #pharmather #anesthesia #analgesia #pharmapatch #stella #reunionneurosciences #stellas (Source: Reuters: Health)
Source: Reuters: Health - June 27, 2023 Category: Consumer Health News Source Type: news

Allecra Therapeutics Submits New Drug Application to the U.S. FDA for Exblifep for the Treatment of Complicated Urinary Tract Infections
SAINT-LOUIS, France& WEIL AM RHEIN, Germany June 27, 2023 --(BUSINESS WIRE)--Allecra Therapeutics (“Allecra”) announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 27, 2023 Category: Drugs & Pharmacology Source Type: news

Verona Pharma Submits New Drug Application to US FDA for Ensifentrine for the Maintenance Treatment of COPD
LONDON and RALEIGH, N.C., June 27, 2023 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the“Company”) announces the submission of a New Drug Application (“NDA”) to the US Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 27, 2023 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Pfizer ’s Application for Hemophilia B Gene Therapy Fidanacogene Elaparvovec
NEW YORK--(BUSINESS WIRE) June 27, 2023 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for fidanacogene elaparvovec for the treatment... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 27, 2023 Category: Drugs & Pharmacology Source Type: news

UCB Provides Update on U.S. FDA Review of the Biologics License Application for Bimekizumab
Brussels (Belgium), 26th June 2023– UCB, a global biopharmaceutical company, today announced that the Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis remains under... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 26, 2023 Category: Drugs & Pharmacology Source Type: news

Aldeyra Therapeutics Provides Regulatory Update on ADX-2191
LEXINGTON, Mass.--(BUSINESS WIRE)--Jun. 21, 2023-- (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced receipt of a Complete... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 21, 2023 Category: Drugs & Pharmacology Source Type: news

F2G Receives Complete Response Letter from FDA for New Drug Application for Olorofim for The Treatment of Invasive Fungal Infections
Complete Response Letter is related to the request for additional data and analyses. F2G remains committed to bringing olorofim to patients and intends to meet with FDA in the coming months to align on next steps to obtain approval using the full... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 20, 2023 Category: Drugs & Pharmacology Source Type: news

ARS Pharmaceuticals Announces PDUFA Date Extension for neffy ® (epinephrine) for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis
SAN DIEGO, June 20, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 20, 2023 Category: Drugs & Pharmacology Source Type: news

Geron Announces Submission of New Drug Application to FDA for First-in-Class Telomerase Inhibitor Imetelstat
FOSTER CITY, Calif.--(BUSINESS WIRE) June 20, 2023 -- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced the submission to the United States Food and Drug Administration (FDA) of a New Drug Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 20, 2023 Category: Drugs & Pharmacology Source Type: news

Pharma major Lupin launches injection to cure thiamine deficiency in US
Pharmaceutical company Lupin on Monday announced that it has launched its generic Thiamine Hydrochloride injection 200 mg/2 mL (100 mg/mL) multiple-dose vials used for treatment of thiamine deficiency in the US. The launch follows alliance partner Caplin Steriles receiving an approval for its ANDA (Abbreviated New Drug Application) from the US Food and Drug Administration (USFDA). (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 19, 2023 Category: Pharmaceuticals Source Type: news

GSK Announces Extension of FDA Review Period for Momelotinib
London, UK 16 June 2023 -- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has extended the review period of the new drug application (NDA) for momelotinib by three months to provide time to review recently... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 18, 2023 Category: Drugs & Pharmacology Source Type: news

Aldeyra Therapeutics Announces Achievement of Statistical Significance for Primary Endpoint and All Secondary Endpoints in Phase 3 INVIGORATE ‑2 Trial of Reproxalap in Allergic Conjunctivitis
Statistical Significance Achieved for Primary Endpoint of Ocular Itching at All Prespecified Timepoints (P<0.0001) Statistical Significance Achieved for Key Secondary Endpoint of Ocular Redness (P=0.004) Statistical Significance Achieved for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 15, 2023 Category: Drugs & Pharmacology Source Type: news