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Nov 26, 2025, 08:00 ET Novo Nordisk files for FDA approval of a higher dose of Wegovy® injection 7.2 mg
with obesity taking semaglutide 7.2 mg as directed lost an average of 20.7% body weight2,3* The supplemental New Drug Application (sNDA) will be reviewed under the FDA's Commissioner's National Priority voucher (CNPV) pilot, which accelerates review for products addressing major national
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Nov 26, 2025, 01:00 ET Renalys Pharma Announces Positive Topline Results from Phase III Study of Sparsentan in Japanese Patients with IgA Nephropathy
standard EU approval for the IgA nephropathy indication in 2025. In 2025, the FDA accepted for review Travere's supplemental new drug application (sNDA) for FILSPARI® for the treatment of focal segmental glomerulosclerosis (FSGS). *FILSPARI® (sparsentan) U.S. Indication:FILSPARI
More news about: Renalys Pharma, Inc.
Nov 24, 2025, 07:00 ET Kelun-Biotech Announces Phase III Trial of Sac-TMT in Combination with KEYTRUDA® (pembrolizumab) as First-Line Treatment for PD-L1-Positive NSCLC Met Primary Endpoint
for Drug Evaluation (CDE) of the National Medical Products Administration of China regarding the submission of a supplemental new drug application (sNDA) of sac-TMT.Sac-TMT is already approved in China for the treatment of EGFR-mutant NSCLC in the second-line and later settings and has achieved
More news about: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Nov 21, 2025, 17:30 ET $HAREHOLDER ALERT: The M&A Class Action Firm Continues to Investigate the Mergers-SNDA, FRGE, BHF, and ORBI.TA
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
Nov 12, 2025, 13:50 ET Halper Sadeh LLC Encourages FRGE, SNDA, GDEN Shareholders to Contact the Firm to Discuss Their Rights
multimedia:https://www.prnewswire.com/news-releases/halper-sadeh-llc-encourages-frge-snda-gden-shareholders-to-contact-the-firm-to-discuss-their-rights-302613316.html
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Nov 11, 2025, 13:53 ET Lundbeck delivers 14% CER revenue growth, reflecting stronger momentum from Vyepti® and Rexulti® driven by additional investments
presented. Lundbeck filed a supplemental new drug application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with PTSD in June 2024. The sNDA is based on data from three randomized clinical trials evaluating the safety and
More news about: H. Lundbeck A/S
Nov 11, 2025, 13:38 ET Lundbeck delivers 14% CER revenue growth, reflecting stronger momentum from Vyepti® and Rexulti® driven by additional investments
presented. Lundbeck filed a supplemental new drug application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with PTSD in June 2024. The sNDA is based on data from three randomized clinical trials evaluating the safety and
More news about: H. Lundbeck A/S
Nov 06, 2025, 12:00 ET Halper Sadeh LLC Encourages JAMF, SNDA, KVUE, SM Shareholders to Contact the Firm to Discuss Their Rights
multimedia:https://www.prnewswire.com/news-releases/halper-sadeh-llc-encourages-jamf-snda-kvue-sm-shareholders-to-contact-the-firm-to-discuss-their-rights-302607425.html
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Nov 06, 2025, 07:30 ET FDA approval of CAPLYTA® (lumateperone) has the potential to reset treatment expectations, offering hope for remission in adults with major depressive disorder
schizophrenia and for the treatment of depressive episodes associated with bipolar I or II disorder. A 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
Nov 05, 2025, 18:23 ET Newmark Serves as Real Estate Advisor on $1.8 Billion Strategic Merger Between Sonida Senior Living and CNL Healthcare Properties
global corporations, and other owners and occupiers, announces the Company has acted as the real estate advisor to Sonida Senior Living, Inc. (NYSE: SNDA), a leading owner and operator of senior housing communities, on its definitive agreement to acquire CNL Healthcare Properties, Inc. in a cash-and-stock
More news about: Newmark Group, Inc.
Oct 31, 2025, 07:49 ET AbbVie Reports Third-Quarter 2025 Financial Results
AbbVie announced the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) that updates the indication statement for Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC)
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Oct 30, 2025, 07:00 ET Insmed Reports Third-Quarter 2025 Financial Results and Provides Business Update
antibiotics. Assuming 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.
More news about: Insmed Incorporated
Oct 29, 2025, 16:01 ET Vanda Pharmaceuticals Reports Third Quarter 2025 Financial Results
framework with the FDA for resolution of certain disputes Re-review of Vanda's sNDA for HETLIOZ ® for the treatment of jet
More news about: Vanda Pharmaceuticals Inc.
Oct 24, 2025, 04:00 ET Renalys Pharma to be Acquired by Chugai Pharmaceutical
received standard EU approval for the IgA nephropathy indication in 2025. In 2025, the FDA accepted for review Travere's supplemental new drug application (sNDA) for FILSPARI® for the treatment of focal segmental glomerulosclerosis (FSGS). *FILSPARI® (sparsentan) U.S. Indication:
More news about: Renalys Pharma, Inc.
Oct 19, 2025, 11:37 ET HARMONi-6 Data: mPFS 11.14 Months (HR=0.6, P<0.0001) Simultaneously Released at ESMO and in The Lancet
cancer treatment. The encouraging results from the HARMONi-6 study have led to the review of a supplemental New Drug Application (sNDA) in China for ivonescimab in combination with chemotherapy as a first-line treatment for advanced squamous NSCLC. Meanwhile, the global enrollment for
More news about: Akeso, Inc.
Oct 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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Oct 17, 2025, 02:00 ET Renalys Pharma Reaches Japan PMDA Agreement on Phase III Clinical Trials of Sparsentan for Focal Segmental Glomerulosclerosis (FSGS) and Alport Syndrome (AS)
obtained standard EU approval for the IgA nephropathy indication in 2025. In 2025, the FDA accepted for review Travere's supplemental new drug application (sNDA) for FILSPARI® for the treatment of focal segmental glomerulosclerosis (FSGS). *FILSPARI® (sparsentan) U.S. Indication:FILSPARI®
More news about: Renalys Pharma, Inc.
Oct 16, 2025, 00:15 ET HARMONi-6 Phase III Study of Ivonescimab Accepted by The Lancet and Selected for ESMO 2025 LBA Presentation
anti-angiogenesis. The encouraging results from the HARMONi-6 study have led to the review of a supplemental New Drug Application (sNDA) in China for ivonescimab in combination with chemotherapy as a first-line treatment for advanced squamous NSCLC.
More news about: Akeso, Inc.
Oct 15, 2025, 10:50 ET Alcoholic Hepatitis Treatment Market to Reach $772.7 Million by 2027 in the short term and $1,064.98 Million by 2034 Globally, at 4.7% CAGR: Allied Market Research
In December 2024, Cumberland Pharmaceuticals Inc. announced the FDA has approved a supplemental New Drug Application (sNDA) for its Acetadote (N-acetylcysteine for injection) product. Acetadote is an intravenous (IV) formulation of N-acetylcysteine (NAC) indicated to prevent
More news about: Allied Market Research
Oct 13, 2025, 13:42 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
More news about: Pomerantz LLP
Oct 13, 2025, 10:57 ET U.S. Food and Drug Administration (FDA) Approves Updated Indication Statement for RINVOQ® (upadacitinib) for the Treatment of Inflammatory Bowel Disease
2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) approval of a supplemental new drug application (sNDA) that updates the indication statement for RINVOQ® (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis
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Oct 10, 2025, 07:30 ET Johnson & Johnson to highlight breadth of its major depressive disorder portfolio at 2025 ECNP Congress
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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Oct 10, 2025, 02:00 ET Renalys Announces Completion of Primary Endpoint Data Collection for Phase III Clinical Trial of Sparsentan for Iga Nephropathy in Japan
and a well-tolerated safety profile compared with active control irbesartan. In 2025, the FDA accepted Travere's supplemental new drug application (sNDA) for FILSPARI® for the treatment of focal segmental glomerulosclerosis (FSGS). In Europe, it also obtained standard EU approval for the IgA nephropathy
More news about: Renalys Pharma, Inc.
Oct 08, 2025, 17:44 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
More news about: Pomerantz LLP
Oct 03, 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
More news about: Pomerantz LLP