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Feb 12, 2026, 18:56 ET INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Vanda Pharmaceuticals Inc. - VNDA
the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) concluding that the supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) for the treatment of jet lag disorder cannot be approved in its current form." The press release stated that "the FDA acknowledged
More news about: Pomerantz LLP
Feb 12, 2026, 18:42 ET INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Pharming Group N.V. - PHAR
"announc[ing] that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to its supplemental New Drug Application (sNDA) for Joenja® (leniolisib), an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, as a treatment for children aged 4 to 11 years with
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Feb 11, 2026, 16:01 ET Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results
(CDER) concluding that the supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) for the treatment of jet lag disorder cannot be approved in the current form. This letter followed CDER's re-review of the jet lag sNDA under Vanda's collaborative framework agreement with the FDA.
More news about: Vanda Pharmaceuticals Inc.
Feb 10, 2026, 10:26 ET Are QIPT, SNDA, FSUN, TBN Obtaining Fair Deals for their Shareholders?
multimedia:https://www.prnewswire.com/news-releases/are-qipt-snda-fsun-tbn-obtaining-fair-deals-for-their-shareholders-302683946.htmlSOURCE
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Feb 05, 2026, 21:53 ET INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Pharming Group N.V. - PHAR
"announc[ing] that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to its supplemental New Drug Application (sNDA) for Joenja® (leniolisib), an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, as a treatment for children aged 4 to 11 years with
More news about: Pomerantz LLP
Jan 29, 2026, 10:00 ET INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Vanda Pharmaceuticals Inc. - VNDA
the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) concluding that the supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) for the treatment of jet lag disorder cannot be approved in its current form." The press release stated that "the FDA acknowledged
More news about: Pomerantz LLP
Jan 28, 2026, 14:23 ET SHAREHOLDER ALERT: The M&A Class Action Firm Continues to Investigate the Merger--CHAC, TRVR, SNDA, and FFWM
SNDA) related to its merger with CNL Healthcare Properties, Inc. Upon completion of the proposed transaction, Sonida existing shareholders' ownership
More news about: Monteverde & Associates PC
Jan 26, 2026, 13:31 ET Halper Sadeh LLC Encourages ONTF, SNDA, ISPO Shareholders to Contact the Firm to Discuss Their Rights
multimedia:https://www.prnewswire.com/news-releases/halper-sadeh-llc-encourages-ontf-snda-ispo-shareholders-to-contact-the-firm-to-discuss-their-rights-302670158.htmlSOURCE
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Jan 22, 2026, 10:00 ET INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Vanda Pharmaceuticals Inc. - VNDA
the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) concluding that the supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) for the treatment of jet lag disorder cannot be approved in its current form." The press release stated that
More news about: Pomerantz LLP
Jan 19, 2026, 06:24 ET Akeso Announces NMPA Acceptance of Second NDA for Gumokimab (IL-17A Inhibitor) in Active Ankylosing Spondylitis
KONG, Jan. 19, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) announced that its supplemental New Drug Application (sNDA) for gumokimab (AK111), a novel humanized anti-IL-17A monoclonal antibody for the treatment of active ankylosing spondylitis (AS), has been accepted
More news about: Akeso, Inc.
Jan 16, 2026, 14:31 ET Sonida Senior Living Investor Alert: Kahn Swick & Foti, LLC Investigates Merger of Sonida Senior Living, Inc. - SNDA
Sonida Senior Living, Inc. (the "Company") (NYSE: SNDA) and CNL Healthcare Properties, Inc. Upon closing of the proposed transaction, Sonida existing shareholders' ownership would range from 39.5% to 50.0%
More news about: Kahn Swick & Foti, LLC
Jan 16, 2026, 14:00 ET SHAREHOLDER ALERT: The M&A Class Action Firm Launches Legal Inquiry into the Merger--TRVR, FFWM, SNDA, and FMNB
SNDA) related to its merger with CNL Healthcare Properties, Inc. Upon completion of the proposed transaction, Sonida existing shareholders' ownership
More news about: Monteverde & Associates PC
Jan 16, 2026, 08:00 ET New clinical data highlights CAPLYTA® (lumateperone) as a promising option for achieving remission in adults with major depressive disorder
need dose titration, allowing patients to start treatment at the effective dose of 42 mg.3,10A supplemental New Drug Application (sNDA) for CAPLYTA® with long-term data evaluating the safety and efficacy of the medication for the prevention of relapse in schizophrenia was
More news about: Johnson & Johnson
Jan 15, 2026, 10:00 ET INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Vanda Pharmaceuticals Inc. - VNDA
the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) concluding that the supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) for the treatment of jet lag disorder cannot be approved in its current form." The press release stated that "the FDA acknowledged
More news about: Pomerantz LLP
Jan 09, 2026, 07:00 ET Insmed Provides Business Update at 44th Annual J.P. Morgan Healthcare Conference
have not started antibiotics.Pending successful results from the ENCORE trial, Insmed 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.TPIP
More news about: Insmed Incorporated
Jan 08, 2026, 07:00 ET Vanda Pharmaceuticals Announces Receipt of FDA Decision Letter on HETLIOZ® Supplemental New Drug Application for Jet Lag Disorder
the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) concluding that the supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) for the treatment of jet lag disorder cannot be approved in its current form. This letter stems from CDER's agreed re-review
More news about: Vanda Pharmaceuticals Inc.
Jan 06, 2026, 13:11 ET SHAREHOLDER ALERT: The M&A Class Action Firm Continues to Investigate the Merger--CRAWA, SNCR, SNDA, and FRGE
SNDA) related to its merger with CNL Healthcare Properties, Inc. Upon completion of the proposed transaction, Sonida existing shareholders' ownership
More news about: Monteverde & Associates PC
Jan 05, 2026, 04:27 ET Kelun-Biotech Announces Breakthrough Therapy Designation Granted in China for Sacituzumab Tirumotecan (sac-TMT) in Combination with Immunotherapy Pembrolizumab for First-Line Treatment of PD-L1-Positive NSCLC
benefits to a greater number of cancer patients.Sac-TMT is the world's first TROP2 ADC drug approved for marketing in lung cancer. In addition, the sNDA for sac-TMT for second-line and above treatment of HR+/HER2- BC was accepted by the Center for Drug Evaluation of the National Medical Products Administration,
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Dec 18, 2025, 18:14 ET Halper Sadeh LLC Encourages FRGE, THS, SNDA, AWK Shareholders to Contact the Firm to Discuss Their Rights
multimedia:https://www.prnewswire.com/news-releases/halper-sadeh-llc-encourages-frge-ths-snda-awk-shareholders-to-contact-the-firm-to-discuss-their-rights-302646425.htmlSOURCE
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Dec 17, 2025, 16:35 ET $HAREHOLDER ALERT: The M&A Class Action Firm Launches Legal Inquiry for the Merger--AWK, SNDA, THS, and WBD
SNDA) related to its merger with CNL Healthcare Properties, Inc. Upon completion of the proposed transaction, Sonida existing shareholders' ownership
More news about: Monteverde & Associates PC
Dec 16, 2025, 20:00 ET Antengene Expands XPOVIO® Indications in Malaysia with Approval in Diffuse Large B-cell Lymphoma
malignancies indications, today announced that the Malaysian National Pharmaceutical Regulatory Agency has approved a supplemental New Drug Application (sNDA) for XPOVIO® (selinexor) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least
More news about: Antengene Corporation Limited
Dec 12, 2025, 20:25 ET U.S. FDA approves AKEEGA® as the first precision therapy for BRCA2-mutated metastatic castration-sensitive prostate cancer with 54% reduction in disease progression vs standard of care*
/PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for AKEEGA® (niraparib and abiraterone acetate dual-action tablet) plus prednisone for the treatment of patients with BRCA2-mutated metastatic
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Dec 08, 2025, 21:02 ET Significant Improvement in Quality of Life Reported in Updated HARMONi-6 Data for Ivonescimab at ESMO Asia
VEGF-targeted therapies in anti-angiogenesis based treatments.In July 2025, based on the HARMONi-6 study results, the supplemental New Drug Application (sNDA) for ivonescimab in combination with chemotherapy as first-line treatment for sq-NSCLC was accepted for review by the Center for Drug Evaluation (CDE)
More news about: Akeso, Inc.
Dec 04, 2025, 07:00 ET Novo Nordisk solicita aprovação da FDA para Wegovy® 7,2 mg, dose mais alta do medicamento
semaglutida 7,2 mg conforme indicado perderam, em média, 20,7% do peso corporal²,³*A solicitação complementar de novo medicamento (sNDA) será avaliada no escopo do piloto do Commissioner's National Priority Voucher (CNPV) da FDA, que acelera a análise de produtos voltados a grandes prioridades
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Nov 28, 2025, 00:13 ET The Annals of Oncology Publishes Results of Phase II Study of Sacituzumab Tirumotecan Monotherapy for Urothelial Carcinoma
progressed after treatment with EGFR-TKI therapy. Sac-TMT is the world's first TROP2 ADC drug approved for marketing in lung cancer. In addition, the sNDA for sac-TMT for the treatment of adult patients with unresectable locally advanced, metastatic HR+/HER2- BC who have received prior endocrine therapy
More news about: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.