Drugs.com - New Drug Applications New drug applications news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.
Ionis Announces FDA Acceptance of New Drug Application for Eplontersen for the Treatment of Hereditary Transthyretin-Mediated Amyloid Polyneuropathy (ATTRv-PN)
on March 7, 2023 at 3:03 am
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...
Avadel Pharmaceuticals Requests Final FDA Approval for Lumryz (sodium oxybate) Extended-Release Oral Suspension
on March 2, 2023 at 1:03 am
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...
FDA Accepts for Priority Review ADX-2191 New Drug Application for the Treatment of Primary Vitreoretinal Lymphoma
on March 2, 2023 at 1:03 am
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...
Cytokinetics Receives Complete Response Letter From FDA for New Drug Application for Omecamtiv Mecarbil
on February 28, 2023 at 1:02 am
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...
Verrica Pharmaceuticals Announces FDA Acceptance of Filing of Resubmitted NDA for VP-102 for the Treatment of Molluscum Contagiosum
on February 27, 2023 at 1:02 am
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,...
Pfizer’s Elranatamab Receives FDA and EMA Filing Acceptance
on February 22, 2023 at 9:02 pm
NEW YORK--(BUSINESS WIRE) February 22, 2023 -- Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the company’s Biologics License Application (BLA) for elranatamab, an...
Pozelimab (C5 Antibody) BLA for Treatment of Children and Adults with Ultra-rare CHAPLE Disease Accepted for FDA Priority Review
on February 21, 2023 at 9:02 pm
If approved, pozelimab would be the first and only treatment for those living with CHAPLE CHAPLE is an ultra-rare hereditary immune disease that causes overactivation of the complement system, leading to potentially life-threatening abdominal and...
FDA Accepts Orasis Pharmaceuticals’ New Drug Application for CSF-1 for the Treatment of Presbyopia
on February 21, 2023 at 1:02 am
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...
Astellas Provides Update on Fezolinetant New Drug Application in U.S.
on February 20, 2023 at 12:02 am
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...
Ocuphire Announces FDA Acceptance of New Drug Application and PDUFA Date for Nyxol Eye Drops for Reversal of Mydriasis
on February 13, 2023 at 5:02 am
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...
Appili Therapeutics Announces that FDA accepts the ATI-1501 NDA
on February 8, 2023 at 5:02 am
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...
Aldeyra Therapeutics Announces FDA Acceptance of New Drug Application for Reproxalap for the Treatment of Dry Eye Disease
on February 7, 2023 at 10:02 pm
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:...
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
on February 6, 2023 at 8:02 pm
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...
Orexo Submits New Drug Application to FDA for OX124, a High-Dose Rescue Medication for Opioid Overdose
on February 3, 2023 at 11:02 pm
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.),...
Cidara Therapeutics and Melinta Therapeutics Announce FDA Advisory Committee Recommends Approval of Rezafungin for the Treatment of Candidemia and Invasive Candidiasis
on January 25, 2023 at 4:02 am
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...
Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum
on January 24, 2023 at 9:02 pm
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...
Fabre-Kramer Pharmaceuticals Announces FDA Acceptance of NDA Resubmission as Complete Response and Assignment of PDUFA Regulatory Action Date
on January 24, 2023 at 4:02 am
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...
Santhera and ReveraGen Announce FDA Acceptance of New Drug Application for Vamorolone in Duchenne Muscular Dystrophy
on January 9, 2023 at 10:01 pm
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...
Novan Submits New Drug Application to the U.S. FDA for Berdazimer Gel, 10.3% (SB206) for the Treatment of Molluscum Contagiosum
on January 6, 2023 at 9:01 pm
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...
Nirsevimab US Regulatory Submission Accepted for the Prevention of RSV Lower Respiratory Tract Disease in Infants and Children up to Age 24 Months
on January 5, 2023 at 12:01 am
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...