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Nov 20, 2025, 08:30 ET Neurocrine Biosciences Announces Publication of Landmark Narrative Review on FDA-Approved VMAT2 Inhibitors Demonstrating Unique Profile of INGREZZA® (valbenazine) Capsules
experience dysphagia, have difficulty swallowing or prefer not to swallow a pill. INGREZZA and INGREZZA SPRINKLE dosages approved for use are 40 mg, 60 mg and 80 mg capsules. Important Information Approved Uses
More news about: Neurocrine Biosciences, Inc.
Nov 20, 2025, 07:00 ET Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics Initiate Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Zipalertinib for Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations who have received prior therapy. Patients were treated with oral zipalertinib 100 mg twice daily. The primary endpoints were objective response rate (ORR) and duration of response (DOR) as assessed by blinded independent central review
More news about: Taiho Oncology
Nov 19, 2025, 21:56 ET Antengene Hosts 2025 R&D Day Showcasing Encouraging Clinical Data and Solid Progress with Investigational Programs
high CLDN18.2 expression (IHC 2+ > 20%), the 2.4 mg/kg dose cohort achieved an objective response rate (ORR) of 40% (12/30), a disease control rate (DCR) of 90% (27/30), and a median overall survival (mOS) of 14.72 months; while the 1.8 mg/kg dose cohort achieved an ORR of 40% (12/30), a
More news about: Antengene Corporation Limited
Nov 19, 2025, 19:00 ET Mazdutide 9 mg Achieves Up to 20.1% Weight Loss in Chinese Adults with Obesity, GLORY-2 Study Meets Primary and All Key Secondary Endpoints
(NDA) of mazdutide 9 mg for weight management to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) in the near term. GLORY-2 (NCT06164873) is a Phase 3 clinical study to evaluate the efficacy and safety of mazdutide 9 mg combined with lifestyle
More news about: Innovent Biologics
Nov 19, 2025, 16:01 ET FDA GRANTS FULL APPROVAL TO AMGEN'S IMDELLTRA® IN EXTENSIVE STAGE SMALL CELL LUNG CANCER
population reflects exposure to intravenous IMDELLTRA®, as a single agent, at the recommended dosage of IMDELLTRA® 1 mg on Cycle 1 Day 1 followed by 10 mg on Days 8 and 15, and then every 2 weeks until disease progression or intolerable toxicity in 473 patients with small cell lung cancer
More news about: Amgen
Nov 19, 2025, 09:55 ET Promising New Data on Pediatric Use of Pretomanid in Children with Drug-Resistant Tuberculosis Presented at 2025 Union Conference
bedaquiline, pretomanid, and linezolid) in adults with drug-resistant tuberculosis (DR-TB). To address the urgent need for child-friendly formulations, 10 mg and 50 mg dispersible tablets were developed and initially studied to confirm they achieved the same drug exposure levels as the existing adult formulation
More news about: IMPAACT
Nov 19, 2025, 09:31 ET Dreamegg Unveils Sunrise Alarm Clocks -- Up to 42% Off for Winter Mornings and Holiday Gifting
https://www.amazon.com/dp/B0D5MG7K8R?maas=maas_adg_C291AC481A849CBA1AFC2F552B945750_afap_abs&ref_=aa_maas&tag=maasUK:
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Nov 19, 2025, 09:17 ET Accelerating Drug Discovery: Tsingke Biotech Unveils Next-Generation Rapid Protein and Antibody Solutions
CHO-K1 systems, achieving milligram-scale yields in 7 days and gram-scale yields in 14 days, with average production exceeding 300 mg/L. A broad range of antibody formats, including VHH-His and VHH-Fc, are available. Tsingke
More news about: Beijing Tsingke Biotech Co., Ltd.
Nov 19, 2025, 09:17 ET Accelerating Drug Discovery: Tsingke Biotech Unveils Next-Generation Rapid Protein and Antibody Solutions
CHO-K1 systems, achieving milligram-scale yields in 7 days and gram-scale yields in 14 days, with average production exceeding 300 mg/L. A broad range of antibody formats, including VHH-His and VHH-Fc, are available. Tsingke
More news about: Beijing Tsingke Biotech Co., Ltd.
Nov 19, 2025, 07:00 ET Rafa Laboratories recebe até US$ 186 milhões da BARDA para desenvolver uma injeção intramuscular de ácido tranexâmico (TXA) para cuidados pré-hospitalares que salvam vidas
civis em todo o mundo, incluindo seu autoinjetor de Midazolam 10 mg (aprovado pela US-FDA sob o NDA #216359 desde 2022) e autoinjetor de Atropina (aprovado pela US-FDA sob o NDA #212319 para 2 mg desde 2018 e EUA # para 0,5 e 1 mg desde 2017). A experiência da empresa abrange toda a cadeia de valor
More news about: Rafa
Nov 19, 2025, 05:00 ET Phase 2 Clinical Trial Results Show Potential to Shorten TB Treatment Time
NC-009 trial (a pan-Phase 2 clinical trial) showed that, overall, sorfequiline had greater activity than bedaquiline. The 100 mg SPaL regimen had greater activity against TB than the standard of care HRZE (isoniazid, rifampin, pyrazinamide, and ethambutol), indicating the potential
More news about: TB Alliance
Nov 19, 2025, 02:55 ET Viking Therapeutics Announces Completion of Enrollment in Phase 3 VANQUISH-1 Trial of VK2735
with at least one weight-related co-morbid condition. Enrolled patients have been randomized to one of four weekly treatment arms: VK2735 7.5 mg, 12.5 mg, 17.5 mg, and placebo. The primary endpoint of the trial is the percent change in body weight from baseline for participants receiving
More news about: Viking Therapeutics, Inc.
Nov 19, 2025, 00:01 ET Rafa Laboratories Awarded up to $186 Million by BARDA to Develop a Life-Saving Intramuscular TXA Injection for Prehospital Care
civilian stockpiles worldwide, including its Midazolam 10 mg autoinjector (US-FDA approved under NDA #216359 since 2022) and Atropine autoinjector (US-FDA approved under NDA #212319 for 2 mg since 2018 and EUA # for 0.5 & 1 mg since 2017). The company's expertise spans the entire value chain
More news about: Rafa
Nov 19, 2025, 00:01 ET Rafa Laboratories Awarded up to $186 Million by BARDA to Develop a Life-Saving Intramuscular TXA Injection for Prehospital Care
civilian stockpiles worldwide, including its Midazolam 10 mg autoinjector (US-FDA approved under NDA #216359 since 2022) and Atropine autoinjector (US-FDA approved under NDA #212319 for 2 mg since 2018 and EUA # for 0.5 & 1 mg since 2017). The company's expertise spans the entire value chain
More news about: Rafa
Nov 18, 2025, 17:31 ET Osteoporosis Market Set to Expand Significantly During the Forecast Period (2025-2034) Due to Rising Aging Population and Novel Therapeutics | DelveInsight
and Organon announced that the US Food and Drug Administration (FDA) had approved BILDYOS (denosumab-nxxp) injection 60 mg/mL and BILPREVDA (denosumab-nxxp) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products.
More news about: DelveInsight Business Research, LLP
Nov 18, 2025, 17:00 ET Rafa Laboratories、院前医療向け救命筋肉内TXA注射剤開発でBARDAから最大1億8,600万ドルの助成金を受給
に医療用対策自動注射器を供給してきました。その中には、ミダゾラム10 mg自動注射器（2022年より米国FDA承認、新薬承認申請番号#216359）およびアトロピン自動注射器（2018年より米国FDA承認、新薬承認申請番号#212319による2 mg製剤、2017年より緊急使用許可#による0.5 mg/1 mg製剤）が含まれます。同社の専門性は、新興の脅威に対応する堅牢な研究開発パイプラインから、cGMP準拠の製造、米国FDAおよび欧州保健当局による規制承認に至るまで、バリュー・チェーン全体に及びます。
More news about: Rafa
Nov 18, 2025, 17:00 ET 라파 연구소, BARDA로부터 최대 1억 8600만 달러 지원받아… 병원 전 단계용 생명구조 근육주사형 TXA 개발 착수
동맹국, 군대 및 전 세계 민간 비축 물자에 의료 대응 자동주사기를 공급해 왔다. 여기에는 미다졸람(Midazolam) 10mg 자동주사기(2022년부터 NDA #216359로 FDA 승인) 및 아트로핀(Atropine) 자동주사기(2mg은 2018년부터 NDA #212319로 FDA 승인, 0.5mg•1mg은 2017년부터 긴급사용승인(EUA))가 포함된다. 라파의 전문성은 신종 위협에 대응하는 강력한 연구개발(R&D) 파이프라인부터 cGMP 준수 제조 및 FDA와 유럽 보건 당국의 성공적인 규제 승인을 포함한 전체 가치 사슬에 걸쳐 있다.
More news about: Rafa
Nov 18, 2025, 11:06 ET European Commission Approves BRINSUPRI® (brensocatib) as the First and Only Treatment To Date Approved for Non-Cystic Fibrosis Bronchiectasis in the European Union
England Journal of Medicine.xii, xiii In ASPEN, patients taking brensocatib 25 mg had a 19.4% reduction in annual rate of exacerbations, as compared to placebo.xii Brensocatib 25 mg also met several exacerbation-related secondary endpoints, including significantly prolonging
More news about: Insmed Incorporated
Nov 18, 2025, 11:00 ET European Commission Approves BRINSUPRI™ (brensocatib) as the First and Only Treatment Approved for Non-Cystic Fibrosis Bronchiectasis in the European Union
patients treated with placebo and BRINSUPRI 10 mg and 25 mg, respectively. Skin Cancers In ASPEN, the incidence of skin cancers among patients treated with BRINSUPRI 10 mg and 25 mg was 0.5% and 1.9%, respectively, compared to
More news about: Insmed Incorporated
Nov 18, 2025, 10:11 ET Neurogan Health Introduces AHK-CU + GHK-CU Hair Serum Pro
known for clean, science-driven innovation, today has introduced AHK-CU + GHK-CU Hair Serum Pro, the first serum spray to combine 2,400mg of GHK-Cu and 2,400mg of AHK-Cu in a precise 1:1 ratio.
More news about: Neurogan Health
Nov 18, 2025, 08:50 ET Halozyme Completes Acquisition of Elektrofi, Expanding Breadth of Offerings in Drug Delivery
maintaining syringeability, which is the ability to inject smoothly and easily. Hypercon™ enables biologic product formulation concentrations of 400-500 mg/ml, which can be up to 4 to 5 times higher than standard aqueous solution formulations for biologics today. The increased concentration reduces the volume
More news about: Halozyme Therapeutics, Inc.
Nov 18, 2025, 08:30 ET Galmed Announces Meaningful Top Line Results from AM-001 Study of Aramchol Meglumine
The top-line results showed that bioavailability of Aramchol meglumine 400mg and 200mg granules is considerably greater, higher by 5-fold and 3-fold respectively, that of the Aramchol free acid 300mg tablets The new unexpected
More news about: Galmed Pharmaceuticals Ltd.
Nov 18, 2025, 08:05 ET Creatine Hydrochloride Found to Mitigate Physical and Cognitive Symptoms in Groundbreaking Study on Menopause
Improvements: Low-dose CrHCL (750 mg/day) significantly improved alertness, executive control, processing speed, and reaction times. Medium-dose CrHCL (1,500 mg/day) enhanced reaction times and reduced mood swings and concentration difficulties. CrHCL-CEE (800 mg/day) alleviated anxiety and improved alertness.
More news about: CON-CRĒT
Nov 18, 2025, 08:00 ET Mabloc and Instituto Butantan Partner to Advance First-in-Class Antibody Therapy for Yellow Fever
bioinformatics to rapidly identify, optimize, and test potent antibodies. In a primate study published in Science Translational Medicine (2023), a single 50mg/kg dose of MBL-YFV-01 fully controlled viremia and prevented severe disease and death in 100% of treated primates. This was followed up with additional
More news about: Mabloc
Nov 18, 2025, 08:00 ET Health~Holland Awards Another Innovative Research Grant for DNA Pol IIIC Inhibitors to Leiden University Medical Center and Acurx Pharmaceuticals
In the Phase 2b trial segment, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI.
More news about: Acurx Pharmaceuticals, Inc.