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May 06, 2026, 08:00 ET Nuvation Bio Announces FDA Acceptance of Supplemental New Drug Application for IBTROZI® (taletrectinib) with Updated Duration of Response in Advanced ROS1-Positive Non-Small Cell Lung Cancer
toughest challenges in cancer treatment, announced today that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) with updated data for IBTROZI® (taletrectinib) in both TKI-naïve and TKI-pretreated advanced ROS1-positive (ROS1+) non-small cell
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May 04, 2026, 16:05 ET BioMarin Reports First Quarter 2026 Financial and Operating Results
expected in 2027.In April, the company submitted its U.S. supplemental new drug application (sNDA) for full approval of VOXZOGO® for achondroplasia. The company expects to be notified of sNDA acceptance by Q3 2026.In May, at the Pediatric Endocrine Society's (PES) annual meeting,
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May 04, 2026, 08:00 ET CAPLYTA® (lumateperone) showed greatest improvement across key efficacy outcomes among adjunctive MDD treatments in new network meta-analysis
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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Apr 30, 2026, 08:00 ET Stealth BioTherapeutics Provides Commercial Launch Update and Pipeline Progress Across Mitochondrial Disease Portfolio
pharmacokinetic study to inform dosing for children weighing less than 30 kilograms, which the Company plans to initiate this year to inform a potential 2027 sNDA submission for children as young as age 5. For infants and younger children, the FDA encouraged continued provision of access through the Company's
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Apr 29, 2026, 07:47 ET AbbVie Reports First-Quarter 2026 Financial Results
AbbVie's aesthetics portfolio, including trenibotulinumtoxinE. AbbVie announced the FDA approved a supplemental new drug application (sNDA) for the combination regimen of Venclexta (venetoclax) and acalabrutinib for the treatment of previously untreated adult patients with chronic lymphocytic
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Apr 27, 2026, 08:00 ET FDA approves CAPLYTA® (lumateperone) sNDA with robust new data supporting reduced risk of relapse in schizophrenia
/PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) based on long-term data evaluating the safety and efficacy of CAPLYTA® (lumateperone) for the prevention of relapse in schizophrenia. The
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Apr 23, 2026, 13:10 ET SHAREHOLDER ALERT: Purcell & Lefkowitz LLP Announces Shareholder Investigation of Sonida Senior Living, Inc. (NYSE: SNDA)
April 23, 2026 /PRNewswire/ -- Purcell & Lefkowitz LLP announces that it is investigating Sonida Senior Living, Inc. (NYSE: SNDA) on behalf of the company's shareholders. The investigation seeks to determine whether Sonida Senior Living's directors breached their fiduciary duties
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Mar 26, 2026, 23:54 ET Akeso Reports Full-Year 2025 Financial Results
commercialized PD-1/VEGF bispecific globally, ivonescimab has secured two approved lung cancer indications in China (both NRDL-listed) with another sNDA under review for the first-line treatment of advanced squamous NSCLC. The Company's expansive global development program
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Mar 24, 2026, 07:00 ET Karyopharm's Phase 3 SENTRY Trial in Myelofibrosis Met First Co-Primary Endpoint, Demonstrating Statistically Significant Improvement in Spleen Volume Reduction
No New Safety Signals Identified –– Karyopharm will Meet with the FDA to Discuss the Totality of the Data and Potential sNDA Filing – – Conference Call Scheduled for Today at 8:00 a.m. ET –NEWTON, Mass.,
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Mar 23, 2026, 07:00 ET Insmed Announces Positive Topline Results from Phase 3b ENCORE Study of ARIKAYCE® (Amikacin Liposome Inhalation Suspension) in Patients with MAC Lung Disease
post-marketing requirement, further strengthening the clinical foundation supporting ARIKAYCE. Insmed plans to file a supplemental new drug application (sNDA) for ARIKAYCE in patients with MAC lung disease in the second half of 2026 to support potential label expansion and to obtain traditional approval for
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Mar 03, 2026, 08:01 ET Vanda Announces FDA Grants Landmark Hearing for HETLIOZ® in Jet Lag Disorder, the First Drug Approval Hearing in Over 40 Years
directing the FDA to finally resolve Vanda's sNDA or commence a hearing.HETLIOZ® is currently approved in the United States for Non-24-Hour Sleep-Wake Disorder and nighttime sleep disturbances associated with Smith-Magenis syndrome. The pending sNDA seeks to expand approval to treat jet lag
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Feb 26, 2026, 15:01 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 26, 2026, 06:59 ET Viatris Reports Fourth-Quarter and Full-Year 2025 Financial Results
announced that the U.S. Food and Drug Administration (FDA) accepted for review the supplemental New Drug Application (sNDA) for MR-141 (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia. The FDA has assigned a PDUFA goal date of October 17, 2026. Presbyopia
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Feb 25, 2026, 06:59 ET FDA Accepts Viatris Supplemental New Drug Application for MR-141 (Phentolamine Ophthalmic Solution 0.75%) for the Treatment of Presbyopia
has accepted for review the supplemental New Drug Application (sNDA) for MR-141 (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia; the FDA has assigned a PDUFA goal date of October 17, 2026; FDA's acceptance of this sNDA for phentolamine ophthalmic solution 0.75% for presbyopia is
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Feb 23, 2026, 16:05 ET BioMarin Reports Fourth Quarter and Full-year 2025 Financial and Operating Results
UpdatesVOXZOGO:Phase 3 hypochondroplasia data 1H'26; regulatory submissions 2H'26U.S. supplemental new drug application (sNDA) for full approval of VOXZOGO in achondroplasia Q2'26Advancing Phase 2 studies in idiopathic short stature, Noonan syndrome, Turner syndrome,
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Feb 20, 2026, 02:00 ET U.S. Food and Drug Administration (FDA) Approves Combination Treatment of VENCLEXTA® (venetoclax) and Acalabrutinib for Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL)
/PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the combination regimen of VENCLEXTA® (venetoclax) and acalabrutinib for the treatment of previously untreated adult patients with chronic lymphocytic
More news about: AbbVie
Feb 19, 2026, 20:04 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
Feb 19, 2026, 07:00 ET Insmed Reports Fourth-Quarter and Full-Year 2025 Financial Results and Provides Business Update
have not started antibiotics.Pending positive topline data 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 second half of 2026. Similarly, Insmed plans
More news about: Insmed Incorporated
Feb 17, 2026, 17:31 ET Juvenile Idiopathic Arthritis Market is Expected to Expand at a Healthy Growth Rate of 5.6% During the Forecast Period (2026-2036) | DelveInsight
treatments, indicating work toward broader global availability for this indication beyond the US.In July 2025, the FDA accepted for review the sNDA for deucravacitinib for the treatment of adults with active psoriatic arthritis. The FDA has assigned a PDUFA goal date of March 6, 2026.
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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
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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
More news about: Pomerantz LLP
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.
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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