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
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
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
Santhera and ReveraGen Announce FDA Acceptance of New Drug Application for Vamorolone in Duchenne Muscular Dystrophy
Pratteln, Switzerland, and Rockville, MD, USA, January 9, 2023– Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 9, 2023 Category: Drugs & Pharmacology Source Type: news
Novan Submits New Drug Application to the U.S. FDA for Berdazimer Gel, 10.3% (SB206) for the Treatment of Molluscum Contagiosum
DURHAM, N.C., Jan. 06, 2023— Novan, Inc. (“the Company” or“Novan”) (Nasdaq: NOVN), announced today that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 6, 2023 Category: Drugs & Pharmacology Source Type: news
Nirsevimab US Regulatory Submission Accepted for the Prevention of RSV Lower Respiratory Tract Disease in Infants and Children up to Age 24 Months
5 January 2023 -- Nirsevimab is being developed and commercialised by AstraZeneca in collaboration with Sanofi and is the first single-dose preventative option for the broad infant population, including those born healthy, at term or preterm, or... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 5, 2023 Category: Drugs & Pharmacology Source Type: news
Checkpoint Therapeutics Submits Biologics License Application to FDA for Cosibelimab as a Treatment for Patients with Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
WALTHAM, Mass., Jan. 04, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced the submission of a Biologics License... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 4, 2023 Category: Drugs & Pharmacology Source Type: news
Fabre-Kramer Submits NDA Amendment for Exxua ™ for Treatment of Major Depressive Disorder
HOUSTON, Jan. 4, 2023 /PRNewswire/— Fabre-Kramer Pharmaceuticals, Inc. (Fabre-Kramer) today announced that on December 23, 2022, it filed an NDA Amendment with the Food and Drug Administration (FDA) for its novel mechanism antidepressant... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 4, 2023 Category: Drugs & Pharmacology Source Type: news
Orasis Pharmaceuticals Submits New Drug Application for Investigational Novel Eye Drop Candidate, CSF-1, for the Treatment of Presbyopia
Ponte Vedra, FL, January 3, 2023– Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on developing a unique eye drop to improve near vision for people with presbyopia, today announced that it has submitted a New... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 3, 2023 Category: Drugs & Pharmacology Source Type: news
Phathom Pharmaceuticals Provides Update on New Drug Application Review of Vonoprazan for Erosive Esophagitis
FLORHAM PARK, N.J., Jan. 03, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases and disorders, today announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 3, 2023 Category: Drugs & Pharmacology Source Type: news
