FDA Accepts Orasis Pharmaceuticals ’ New Drug Application for CSF-1 for the Treatment of Presbyopia
Investigational, novel eye drop candidate was assigned PDUFA goal date of October 22, 2023 Ponte Vedra, FL, February 21, 2023– Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on developing a unique eye drop... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 21, 2023 Category: Drugs & Pharmacology Source Type: news

Astellas Provides Update on Fezolinetant New Drug Application in U.S.
TOKYO, Feb. 19, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., " Astellas " ) today announced the U.S. Food and Drug Administration (FDA) notified the company that it is extending the original priority... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 20, 2023 Category: Drugs & Pharmacology Source Type: news

Soligenix Receives Refusal to File Letter from U.S. FDA for HyBryte(TM) New Drug Application in the Treatment of Cutaneous T-Cell Lymphoma
Soligenix intends to seek guidance from the FDA on how to further advance HyBryte™ towards potential approval PRINCETON, N.J., Feb. 14, 2023 -- (Healthcare Sales & Marketing Network) -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-... Biopharmaceuticals, Oncology, FDA Soligenix, HyBryte, synthetic hypericin, photodynamic therapy, CTCL (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 14, 2023 Category: Pharmaceuticals Source Type: news

Ocuphire Announces FDA Acceptance of New Drug Application and PDUFA Date for Nyxol Eye Drops for Reversal of Mydriasis
FARMINGTON HILLS, Mich., Feb. 13, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 13, 2023 Category: Drugs & Pharmacology Source Type: news

Natco Pharma submits application with USFDA for generic cancer drug
The company has submitted an Abbreviated New Drug Application (ANDA) containing a 'paragraph IV' certification with the US Food and Drug Administration (FDA) for the product, a generic version of AstraZeneca's Olaparib tablets in strengths of 100mg and 150mg. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - February 13, 2023 Category: Pharmaceuticals Source Type: news

FDA Approves Pfizer's Supplemental New Drug Application for Cibinqo (abrocitinib) to Include Adolescents with Moderate-to-Severe Atopic Dermatitis
Label expansion for Cibinqo provides new systemic oral option for adolescents (12 to<18 years) with moderate-to-severe atopic dermatitis NEW YORK--(BUSINESS WIRE) February 10, 2023 -- Pfizer Inc. (NYSE: PFE) announced today that the United... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 10, 2023 Category: Drugs & Pharmacology Source Type: news

Appili Therapeutics Announces that FDA accepts the ATI-1501 NDA
HALIFAX, Nova Scotia, February 8, 2023– Appili Therapeutics Inc. (TSX: APLI (the“Company” or“Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today, with its... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 8, 2023 Category: Drugs & Pharmacology Source Type: news

Aldeyra Therapeutics Announces FDA Acceptance of New Drug Application for Reproxalap for the Treatment of Dry Eye Disease
PDUFA Date is November 23, 2023 First-in-Class RASP Modulator Represents a Potential New Therapeutic Paradigm for Patients Suffering from Dry Eye Disease LEXINGTON, Mass.--(BUSINESS WIRE)--Feb. 7, 2023-- Aldeyra Therapeutics, Inc. (Nasdaq:... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 7, 2023 Category: Drugs & Pharmacology Source Type: news

Biogen and Sage Therapeutics Announce FDA Accepts Filing of New Drug Application and Grants Priority Review of Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression
Zuranolone is being evaluated as a potential 14-day, rapid-acting, once-daily, oral medication to treat major depressive disorder (MDD) and postpartum depression (PPD) Depression is a public health issue with significant unmet medical... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 6, 2023 Category: Drugs & Pharmacology Source Type: news

Orexo Submits New Drug Application to FDA for OX124, a High-Dose Rescue Medication for Opioid Overdose
OX124 is designed to reverse the effects of the most powerful synthetic opioids, such as fentanyl Nine out of ten fatal opioid overdoses in the US involve synthetic opioids Uppsala, Sweden– February 3, 2023– Orexo AB (publ.),... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 3, 2023 Category: Drugs & Pharmacology Source Type: news

Generic Drugs Program Activities Report - FY 2022 Monthly Performance
This report provides monthly activities metrics for the FDA Generic Drugs Program, outlining agency actions on abbreviated new drug applications. Data includes approvals, applications received, complete responses, and more. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - February 3, 2023 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Cidara Therapeutics and Melinta Therapeutics Announce FDA Advisory Committee Recommends Approval of Rezafungin for the Treatment of Candidemia and Invasive Candidiasis
FDA decision expected by PDUFA target action date of March 22, 2023 If approved, rezafungin will be the first new drug for the treatment of candidemia and invasive candidiasis in over a decade SAN DIEGO and PARSIPPANY, N.J., Jan. 25, 2023... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 25, 2023 Category: Drugs & Pharmacology Source Type: news

Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum
Potential First FDA-approved Therapy for Treatment of Molluscum Contagiosum Prevalence of Over 6 Million Molluscum Contagiosum Patients in the U.S. Alone WEST CHESTER, PA– January 24, 2023 (GLOBE NEWSWIRE)– Verrica... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 24, 2023 Category: Drugs & Pharmacology Source Type: news

Fabre-Kramer Pharmaceuticals Announces FDA Acceptance of NDA Resubmission as Complete Response and Assignment of PDUFA Regulatory Action Date
HOUSTON, Jan. 24, 2023 -- Fabre-Kramer Pharmaceuticals, a leading developer of novel small molecule medications to address unmet needs in the treatment of psychiatric and neurological disorders, announced today it received on January 20, 2023... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 24, 2023 Category: Drugs & Pharmacology Source Type: news

Eli Lilly ’ s Alzheimer ’s Drug Donanemab Fails to Get Early FDA Approval
Eli Lilly & Co.’s bid for accelerated approval of its Alzheimer’s therapy donanemab was rejected by U.S. regulators, an unexpected setback for the drugmaker. The Food and Drug Administration sent the company a complete response letter saying it would not give the early approval for the drug because not enough patients on the trial had received it for a full 12 months, Lilly said Thursday in a statement. The agency wanted Lilly to provide safety data on at least 100 patients who had been on the drug for a year. Lilly’s application for accelerated approval was based on a relatively small mid-stage trial...
Source: TIME: Health - January 20, 2023 Category: Consumer Health News Authors: Robert Langreth and Nacha Cattan/Bloomberg Tags: Uncategorized bloomberg wire Drugs Source Type: news