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Sep 08, 2026, 08:00 ET Johnson & Johnson spotlights new neuropsychiatry data across bipolar mania, depression and schizophrenia at Psych Congress 2026
serotonin 5-HT2A receptors and partial agonist activity at central dopamine D2 receptors.A supplemental New Drug Application (sNDA) for CAPLYTA® with long-term data evaluating the safety and efficacy of the medication for delayed time to relapse in schizophrenia was recently
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Aug 31, 2026, 07:30 ET Karyopharm Submits Supplemental New Drug Application to the FDA for XPOVIO® (selinexor) Plus Ruxolitinib for Patients with Myelofibrosis
to traditional approval and expects to continue working with the FDA during its review of the sNDA to finalize the confirmatory evidence plan. Karyopharm expects to receive notice of the FDA's decision on sNDA filing acceptance and, if accepted, the anticipated review timelines in the fourth quarter of
More news about: Karyopharm Therapeutics Inc.
Aug 21, 2026, 04:03 ET Dizal to Present Emerging Data on ZEGFROVY® in Non-Small Cell Lung Cancer at WCLC 2026
addition, with positive results from WU-KONG28, a multinational randomized Phase 3 study in treatment naïve patients, the Supplemental New Drug Application (sNDA) of ZEGFROVY as first-line treatment has been submitted to China Center for Drug Evaluation (CDE) and the US Food and Drug Administration (FDA). On
More news about: Dizal Pharmaceutical
Aug 17, 2026, 10:32 ET Hypertrophic Cardiomyopathy Market Set for Transformation Over the Next Decade with the Emergence of Targeted Cardiac Therapies Beyond Conventional Beta-blockers, Calcium Channel Blockers, and Antiarrhythmic Agents | DelveInsight
Cardiomyopathy MarketIn June 2026, Bristol Myers Squibb announced the US FDA accepted a supplemental New Drug Application (sNDA) for Mavacamten as a potential treatment for adolescents (ages 12 years to <18 years) with symptomatic oHCM. The FDA has granted the application
More news about: DelveInsight Business Research, LLP
Aug 13, 2026, 07:30 ET Karyopharm Reports Second Quarter 2026 Financial Results and Highlights Continued Progress Toward Myelofibrosis sNDA Submission
– Planned August sNDA Submission for Selinexor in Combination with Ruxolitinib in Myelofibrosis under the Accelerated Approval Pathway Remains on Track – – Planned sNDA for Selinexor plus Ruxolitinib Supported by Phase 3 SENTRY Results Presented at ASCO
More news about: Karyopharm Therapeutics Inc.
Aug 12, 2026, 08:17 ET Ivonescimab Plus Chemotherapy Approved for First-Line Squamous NSCLC; HARMONi-6 Establishes New Gold Standard in Lung Cancer Treatment
or the "Company") today announced that the China National Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for ivonescimab injection in combination with chemotherapy for the first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC).
More news about: Akeso, Inc.
Aug 10, 2026, 10:31 ET Major Depressive Disorder Market is Predicted to Grow During the Forecast Period (2026-2036) as Novel Antidepressants are Expected to Enter the Market | DelveInsight
network meta-analysis.In April 2026, Johnson & Johnson announced that the US FDA had approved a supplemental New Drug Application (sNDA) based on long-term data evaluating the safety and efficacy of lumateperone (CAPLYTA) for the prevention of relapse in schizophrenia.Major
More news about: DelveInsight Business Research, LLP
Aug 06, 2026, 16:03 ET BioMarin Reports Second Quarter 2026 Financial and Operating Results
Business and Pipeline HighlightsInnovationBioMarin recently submitted its supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the approval of VOXZOGO for the treatment of hypochondroplasia. If approved, VOXZOGO would be the
More news about: BioMarin Pharmaceutical Inc.
Aug 06, 2026, 07:30 ET Nuvation Bio Reports Second Quarter 2026 Financial Results and Provides Business Update
(ROS1+ NSCLC).In May 2026, Nuvation Bio announced that the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for IBTROZI with updated efficacy data in TKI-naïve and TKI-pretreated advanced ROS1+ NSCLC, with a target action date of January 4, 2027. The submission
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Aug 06, 2026, 07:00 ET Insmed Reports Second-Quarter 2026 Financial Results and Provides Business Update
quarter of 2025, primarily driven by strong growth in international markets.In July 2026, Insmed submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for ARIKAYCE in newly diagnosed patients with MAC lung disease. Similarly, Insmed plans to review the
More news about: Insmed Incorporated
Jul 30, 2026, 16:06 ET Karyopharm Plans to Submit sNDA for Selinexor Plus Ruxolitinib in Myelofibrosis Under Accelerated Approval Pathway
– Company Plans to Submit sNDA in August 2026 and Will Request Priority Review –– Following FDA Engagements, Company Plans to Submit sNDA under Accelerated Approval Based Upon Compelling SVR35 Data and Preliminary Overall Survival Data Observed at the
More news about: Karyopharm Therapeutics Inc.
Jul 30, 2026, 16:05 ET Karyopharm Announces Topline Results from Phase 3 XPORT-EC-042 Trial in Endometrial Cancer
myeloma business. Looking ahead, we expect several important milestones in our myelofibrosis program over the next year, including the submission of our sNDA, the potential addition of selinexor to relevant compendia guidelines and topline data from the 60 mg cohort of the Phase 2 SENTRY-2 trial, each anticipated
More news about: Karyopharm Therapeutics Inc.
Jul 21, 2026, 08:30 ET Billions Flow Into Next-Generation Depression Treatments as Pharma Innovation Accelerates
announced last year the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for SPRAVATO® (esketamine) CIII nasal spray, making this innovative treatment the first and only monotherapy for adults living with major depressive
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Jul 14, 2026, 02:00 ET Dizal Announces Global Exclusive License Agreement with AstraZeneca for Zegfrovy
is supported by WU-KONG1 Part B, a multinational pivotal study investigating the efficacy and safety of Zegfrovy in the same indication. The sNDA for previously untreated NSCLC with EGFR exon20ins has been submitted to China Center for Drug Evaluation (CDE) and
More news about: Dizal
Jul 13, 2026, 09:05 ET U.S. Food and Drug Administration Accepts BioMarin's Supplemental New Drug Application for Full Approval of VOXZOGO® (vosoritide) for Children With Achondroplasia
Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for VOXZOGO® (vosoritide) for full approval in children with achondroplasia. The FDA has set a Prescription Drug User Fee Act (PDUFA)
More news about: BioMarin Pharmaceutical Inc.
Jul 08, 2026, 08:00 ET Mighty Therapeutics Announces First Patient Dosed in Phase 4 Confirmatory Study of Elamipretide in Barth Syndrome
children weighing less than 30 kilograms, which the Company plans to initiate this year to support a potential 2027 supplemental new drug application (sNDA) submission for children as young as age 5. For infants and younger children, the Company is working to initiate a registry to standardize the collection
More news about: Mighty Therapeutics
Jun 17, 2026, 11:04 ET DossDocs Launches On-Demand SBA 7(a) Regular and 7(a) Express Loan Document Automation
fees, net funding, permitted-purpose allocations, and all SBA Settlement Statement calculations.Supporting Documents IncludedSNDA, Business Purpose Certificate, Junior Lienholder Authorization, Holdback Agreement, Environmental Indemnity, Compliance Agreement, AML Declaration, ACH
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Jun 11, 2026, 21:57 ET Akeso's Gumokimab (AK111, Anti-IL-17) Approved by NMPA for Moderate-to-Severe Plaque Psoriasis, Bolstering Its Autoimmune Disease Portfolio
synergies and strengthening Akeso's global competitiveness."In addition to moderate-to-severe plaque psoriasis, a supplemental New Drug Application (sNDA) for gumokimab in active ankylosing spondylitis has been accepted for review by the Center for Drug Evaluation (CDE) of the NMPA.About AkesoAkeso
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Jun 08, 2026, 05:00 ET Foresee's Oral ALDH2 Activator, Mirivadelgat to Enter Clinical Testing in Parkinson's Disease in the SLEIPNIR Phase 2a Platform Trial
has completed its Phase 3 clinical trial for another indication in premenopausal breast cancer in China, and the supplemental New Drug Application (sNDA) for leuprolide injectable emulsion in premenopausal breast cancer has been accepted by China NMPA. Aderamastat (FP-025), a highly selective oral MMP-12
More news about: Foresee Pharmaceuticals Co., Ltd.
May 27, 2026, 08:00 ET Nuvation Bio to Present New Quality-of-Life Data for IBTROZI® (Taletrectinib) in Patients with ROS1-Positive Non-Small Cell Lung Cancer at ASCO 2026 Annual Meeting
the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. In May 2026, the FDA accepted a supplemental New Drug Application (sNDA) with updated data for IBTROZI with a target action date of January 4, 2027. IBTROZI is also approved for patients with advanced ROS1+ NSCLC in Japan,
More news about: Nuvation Bio Inc.
May 27, 2026, 06:40 ET Dizal's ZEGFROVY® (Sunvozertinib) New Drug Application Accepted and Granted Priority Review by China National Medical Products Administration for First-Line Treatment of EGFR Exon 20 Insertion-Mutated Non-Small Cell Lung Cancer
ZEGFROVY was granted accelerated approval previously by China's CDE and the U.S. Food and Drug Administration (FDA). The new sNDA is based on the results of WU-KONG28 study, a confirmatory, multinational, randomized phase 3 study evaluating ZEGFROVY versus platinum-containing chemo
More news about: Dizal Pharmaceutical
May 21, 2026, 20:00 ET Kelun-Biotech to Present Two Registrational Studies in the Oral Presentation Session on Non-Small Cell Lung Cancer at ASCO 2026
compared to pembrolizumab in first-line treatment for PD-L1 positive advanced NSCLC. Based on these results, a supplemental New Drug Application (sNDA) for this combination regimen has been accepted for review and included in the priority review and approval process by the National Medical Products
More news about: Kelun-Biotech
May 20, 2026, 16:20 ET BioMarin Announces Positive Phase 3 Pivotal Study Results for VOXZOGO® (vosoritide) in Children with Hypochondroplasia
this post-marketing requirement, BioMarin submitted its U.S. supplemental New Drug Application (sNDA) for full approval of VOXZOGO for achondroplasia in April 2026, and the company expects to be notified of sNDA acceptance by the third quarter of 2026.The use of VOXZOGO to treat hypochondroplasia
More news about: BioMarin Pharmaceutical Inc.
May 14, 2026, 07:30 ET Karyopharm Reports First Quarter 2026 Financial Results and Completion of Phase 3 Endometrial Cancer Trial Enrollment
Engage with the U.S. Food and Drug Administration (FDA) on the data from the SENTRY trial and the Company's supplemental new drug application (sNDA) filing plan; engage with other global regulatory agencies in collaboration with the Company's partners. The Company
More news about: Karyopharm Therapeutics Inc.
May 08, 2026, 06:40 ET The sNDA for Sacituzumab Tirumotecan (sac-TMT) in Combination with Pembrolizumab as First‑Line Treatment for PD-L1-positive NSCLC Accepted for Review by NMPA
May 8, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company") announced that the sNDA (the "Application") for the Company's TROP2 ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱®)
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