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Oct 01, 2025, 17:02 ET Vanda Pharmaceuticals Announces Collaborative Framework for Resolution of Disputes with the U.S. Food and Drug Administration
action date of December 30, 2025. The FDA will conduct an expedited re-review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ® for the treatment of jet lag disorder by January 7, 2026, including consideration of alternative or narrowed indications focusing
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Sep 28, 2025, 10:00 ET INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Agios Pharmaceuticals, Inc. - AGIO
U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Application (sNDA) of PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator, for the treatment of adult patients with non-transfusion-dependent (NTD) and transfusion-dependent
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Sep 25, 2025, 08:00 ET Vanda Pharmaceuticals announces the publication in PLOS One of an article titled "Melatonin agonist tasimelteon (HETLIOZ®) improves sleep in patients with primary insomnia: A multicenter, randomized, double-blind, placebo-controlled trial"
regarding the Company's supplemental New Drug Application (sNDA) for HETLIOZ® in the treatment of insomnia and Vanda's ability to obtain FDA approval thereof, the outcome of the FDA's further review of the supplemental New Drug Application (sNDA) for HETLIOZ® in the treatment of Jet Lag
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Sep 24, 2025, 17:31 ET Moderate-to-Severe Acute Pain Market Anticipates Impressive Growth Trajectory at a CAGR of 14% During the Study Period (2020-2034) | DelveInsight
(capsaicin) 8% topical system is expected to report topline data in Q4 2025, with Averitas Pharma planning to file a supplemental new drug application (sNDA) in 2026, pending positive outcomes. In Japan, acute pain treatment options are relatively scarce, with only
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Sep 23, 2025, 10:00 ET INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Agios Pharmaceuticals, Inc. - AGIO
U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Application (sNDA) of PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator, for the treatment of adult patients with non-transfusion-dependent (NTD) and transfusion-dependent
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Sep 22, 2025, 22:56 ET Ivonescimab HARMONi-6 Results Selected for ESMO 2025 LBA; Final Phase III Results of Cadonilimab as First-Line Therapy for Advanced Gastric Cancer to Be Published as an Oral Presentation
2025, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) accepted the supplemental New Drug Application (sNDA) for ivonescimab in combination with chemotherapy as a first-line treatment for advanced sq-NSCLC.
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Sep 18, 2025, 10:00 ET INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Agios Pharmaceuticals, Inc. - AGIO
U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Application (sNDA) of PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator, for the treatment of adult patients with non-transfusion-dependent (NTD) and transfusion-dependent
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Sep 18, 2025, 05:49 ET AGIO Investors Have Opportunity to Join Agios Pharmaceuticals, Inc. Fraud Investigation with the Schall Law Firm
September 4, 2025, that the FDA "has extended the Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Application (sNDA) of PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator, for the treatment of adult patients with non-transfusion-dependent (NTD) and transfusion-dependent
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Sep 15, 2025, 08:00 ET Johnson & Johnson to showcase industry-leading neuropsychiatry innovations at the 2025 Psych Congress Annual Meeting
5-HT2A receptor occupancy and lower amounts of dopamine D2 receptor occupancy at therapeutic doses. A supplemental new drug application (sNDA) for CAPLYTA® as an adjunctive treatment for adults with major depressive disorder is currently under U.S. Food and Drug Administration review.
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Sep 13, 2025, 12:30 ET INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Agios Pharmaceuticals, Inc. - AGIO
U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Application (sNDA) of PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator, for the treatment of adult patients with non-transfusion-dependent (NTD) and transfusion-dependent
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Sep 08, 2025, 15:00 ET INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Agios Pharmaceuticals, Inc. - AGIO
U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Application (sNDA) of PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator, for the treatment of adult patients with non-transfusion-dependent (NTD) and transfusion-dependent
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Sep 04, 2025, 11:35 ET RNAi Technology Market Size to Reach USD 6.63 Billion with 10.4% CAGR by 2033, Report by DataM Intelligence
antibodies).In March 2025, Alnylam Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approval of the supplemental New Drug Application (sNDA) for its RNAi therapeutic, AMVUTTRA (vutrisiran), for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis
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Sep 03, 2025, 06:50 ET Diabetic Foot Ulcers Market Size to Reach USD 9.25 Billion with 6.1% CAGR by 2033, Report by DataM Intelligence
2025, Alnylam Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approval of the supplemental New Drug Application (sNDA) for its RNAi therapeutic, AMVUTTRA (vutrisiran), for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis
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Aug 26, 2025, 12:52 ET Akeso's 2025 Interim Results: Commercial Sales Reach New All-Time Highs
dataIvonescimab secures approval for first-line treatment of NSCLC (significant positive outcomes from HARMONi-2 compared to pembrolizumab)sNDA for ivonescimab in first-line treatment of sq-NSCLC (significant positive findings from HARMONi-6 compared to tislelizumab + chemotherapy)Global
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Aug 18, 2025, 07:00 ET In a Major Win for Vanda, a Federal Appeals Court Overturns FDA's Order Denying Approval of Hetlioz for the Treatment of Jet Lag Disorder
the FDA to finally resolve Vanda's sNDA or commence a hearing (Vanda Pharmaceuticals Inc. v. FDA, No. 22-cv-2775-CJN). The FDA did not commence a hearing. It instead granted summary judgment to itself and issued an order refusing to approve the sNDA. The FDA took the position that it could
More news about: Vanda Pharmaceuticals Inc.
Aug 07, 2025, 07:00 ET Insmed Reports Second-Quarter 2025 Financial Results and Provides Business Update
not started antibiotics.Assuming successful results from the ENCORE trial, the Company plans to submit a supplementary new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for ARIKAYCE in all patients with MAC lung disease in the U.S. in the second half of 2026.Brensocatib
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Jul 31, 2025, 07:44 ET AbbVie Reports Second-Quarter 2025 Financial Results
often faces poor prognosis and has limited treatment options. AbbVie announced the submission of a supplemental New Drug Application (sNDA) to the FDA for Venclexta (venetoclax) and acalabrutinib combination therapy for the treatment of chronic lymphocytic leukemia (CLL). This combination
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Jul 29, 2025, 08:00 ET AbbVie Submits for U.S. FDA Approval of Combination Treatment of VENCLEXTA® (venetoclax) and Acalabrutinib for Previously Untreated Patients with Chronic Lymphocytic Leukemia (CLL)
July 29, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the fixed-duration, all-oral combination regimen of VENCLEXTA® (venetoclax) and acalabrutinib
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Jul 28, 2025, 08:00 ET Servier Announces Positive Data from Long-Term Follow-Up Analysis of the Phase 3 AGILE Trial of TIBSOVO® (ivosidenib) in IDH1-mutated Acute Myeloid Leukemia
preclude use of intensive induction chemotherapy, in May 2022 under Priority Review. The supplemental New Drug Application (sNDA) for TIBSOVO was reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments
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Jul 28, 2025, 00:14 ET NMPA Accepts sNDA for Ivonescimab in Combination with Chemotherapy as First-Line Treatment for Advanced Squamous Non-Small Cell Lung Cancer
the "Company") is pleased to announce that the National Medical Products Administration (NMPA) has accepted the supplementary New Drug Application (sNDA) for ivonescimab (PD-1/VEGF bispecific antibody) in combination with chemotherapy as a first-line treatment for advanced squamous non-small cell lung
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Jul 09, 2025, 16:00 ET Taiho Oncology and Taiho Pharmaceutical Announce U.S. FDA Acceptance of Supplemental New Drug Application for INQOVI® in Combination with Venetoclax to Treat Patients with Acute Myeloid Leukemia
and Taiho Pharmaceutical Co., Ltd., announced today that the U.S. Food and Drug Administration (FDA) has accepted their supplemental new drug application (sNDA) for INQOVI (decitabine and cedazuridine) plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia (AML) who are ineligible
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Jul 08, 2025, 08:00 ET Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo
July 8, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based upon long-term data evaluating the safety and efficacy of CAPLYTA® (lumateperone) for
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Jul 02, 2025, 10:00 ET INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Travere Therapeutics, Inc. - TVTX
("FDA") "has indicated that it is currently planning to hold an advisory committee meeting to discuss" the Company's "supplemental New Drug Application (sNDA) for traditional approval of FILSPARI (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS)." On this news, Travere's
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Jun 26, 2025, 17:46 ET Post-Traumatic Stress Disorder Market Set to Expand Significantly During the Study Period (2020-2034) with Pipeline Innovation and Unmet Needs | DelveInsight
announced that the FDA would convene a Psychopharmacologic Drugs Advisory Committee (PDAC) meeting to evaluate the Supplemental New Drug Application (sNDA) for the brexpiprazole-sertraline combination in the treatment of adult PTSD. This advisory meeting, anticipated in the first half of 2025, has postponed
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Jun 22, 2025, 10:00 ET INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Travere Therapeutics, Inc. - TVTX
("FDA") "has indicated that it is currently planning to hold an advisory committee meeting to discuss" the Company's "supplemental New Drug Application (sNDA) for traditional approval of FILSPARI (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS)." On this news, Travere's
More news about: Pomerantz LLP