New Drug Applications Clinical Trials This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Viatris and Mapi Pharma Statement Regarding New Drug Application for GA Depot
March 11, 2024 -- Viatris Inc. has been informed that Mapi Pharma Ltd. has received a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for GA Depot 40 mg from the U.S. Food and Drug Administration (FDA). The Companies are... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 11, 2024 Category: Pharmaceuticals Source Type: clinical trials

Everest Medicines Announces Investigational New Drug Application Acceptance of Zetomipzomib in China
SHANGHAI, Dec. 3, 2023. Everest Medicines ( " Everest " , or the " Company " ), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, today announced that China National Medical... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 4, 2023 Category: Pharmaceuticals Source Type: clinical trials

PepGen Inc. Announces FDA has Lifted the Clinical Hold on its Investigational New Drug Application for FREEDOM-DM1 Phase 1 Study of PGN-EDODM1 for Myotonic Dystrophy Type 1 (DM1)
Safety, transcript splicing and clinical outcome measures data at 5 mg/kg PGN-EDODM1 dose level in patients from FREEDOM-DM1 clinical study expected in 2024 Continue to expect safety, muscle exon skipping and dystrophin data at 5 mg/kg PGN-EDO51... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 12, 2023 Category: Pharmaceuticals Source Type: clinical trials

Allos Pharma Inc. Receives FDA Guidance for the Design of a Phase 3 Trial to Support a New Drug Application for Treatment of Fragile X Syndrome
CAMBRIDGE, Mass., May 23, 2023. Allos Pharma Inc. ( " Allos " ), a biopharmaceutical company specializing in the development of treatments for rare neurological disorders, announced today that it has held a meeting with the U.S. Food and Drug... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 23, 2023 Category: Pharmaceuticals Source Type: clinical trials

Soligenix Receives Refusal to File Letter from U.S. FDA for HyBryte ™ 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 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 14, 2023 Category: Pharmaceuticals Source Type: clinical trials

New Drug Application for RiVive Over-the-Counter Naloxone Nasal Spray Accepted and Granted Priority Review by FDA
PITTSBURGH, Dec. 26, 2022. Harm Reduction Therapeutics (HRT), Inc., a 501(c)(3) nonprofit pharmaceutical company whose mission is to prevent opioid overdose deaths by making free or low-cost over-the-counter (OTC) naloxone nasal spray available to... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 26, 2022 Category: Pharmaceuticals Source Type: clinical trials

AbbVie Submits Supplemental New Drug Application to Support New Indication of Linzess for Functional Constipation in Children and Adolescents
NORTH CHICAGO, Ill., Dec. 16, 2022 . AbbVie today announced that it has submitted a supplemental New Drug Application (sNDA) for linaclotide (LINZESS) to the U.S. Food and Drug Administration (FDA) for the treatment of children and adolescents 6 to... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 16, 2022 Category: Pharmaceuticals Source Type: clinical trials

Emergent BioSolutions Announces U.S. FDA Acceptance and Priority Review of Supplemental New Drug Application for Over-the-Counter Narcan (naloxone HCl) Nasal Spray
Emergent’s supplemental new drug application is the first prescription-to-over-the-counter switch application in history to be granted Priority Review by the FDA. NARCAN® (naloxone HCI) Nasal Spray 4 mg, the first intranasal form of... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 6, 2022 Category: Pharmaceuticals Source Type: clinical trials

EAGLE-2 and EAGLE-3 Phase III Trials for Gepotidacin Stopped Early for Efficacy Following Pre-Planned Interim Analysis by Independent Data Monitoring Committee
Gepotidacin could be the first new novel oral antibiotic treatment for uncomplicated urinary tract infections in over 20 years GSK plans to submit a New Drug Application for gepotidacin to the US Food and Drug Administration (FDA) in H1... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 3, 2022 Category: Pharmaceuticals Source Type: clinical trials

Pharming Announces US FDA Acceptance for Priority Review of its New Drug Application for Leniolisib
LEIDEN, The Netherlands, Sept. 28, 2022.Pharming Group N.V. ( " Pharming " or " the Company " ) announces that the US Food and Drug Administration (FDA) has accepted for priority review its New Drug Application (NDA) for leniolisib, an oral, selective... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 28, 2022 Category: Pharmaceuticals Source Type: clinical trials

Ocuphire Pharma Receives PDUFA Fee Waiver for Nyxol New Drug Application from FDA
NDA Submission for Nyxol Eye Drops in First Indication on Track for Late 2022 FARMINGTON HILLS, Mich., Sept. 12, 2022 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 12, 2022 Category: Pharmaceuticals Source Type: clinical trials

U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant
TOKYO, Aug. 18, 2022. Astellas Pharma Inc. ( " Astellas " ) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company ' s New Drug Application (NDA) for fezolinetant, an investigational oral, nonhormonal compound seeking... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 18, 2022 Category: Pharmaceuticals Source Type: clinical trials

Roche announces U.S. FDA approval of Xofluza to treat influenza in children aged five years and older
Basel, 12 August 2022 - Roche today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 12, 2022 Category: Pharmaceuticals Source Type: clinical trials

Basilea Announces Positive Results of Phase 3 ERADICATE Study with Ceftobiprole in Staphylococcus Aureus Bacteremia (SAB)
Ceftobiprole met primary and secondary efficacy endpoints Basilea plans to submit a New Drug Application (NDA) in the U.S. around year end 2022 Basel, Switzerland, June 28, 2022 -- Basilea Pharmaceutica Ltd (SIX: BSLN), a commercial-stage... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 28, 2022 Category: Pharmaceuticals Source Type: clinical trials

Eplontersen Met Co-Primary and Secondary Endpoints in Interim Analysis of the NEURO-TTRansform Phase III Trial for Hereditary Transthyretin-Mediated Amyloid Polyneuropathy (ATTRv-PN)
New Drug Application filing anticipated based on positive data from interim analysis 21 June 2022 -- Positive high-level results from the NEURO-TTRansform Phase III trial in patients with hereditary transthyretin-mediated amyloid... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 21, 2022 Category: Pharmaceuticals Source Type: clinical trials