Small Molecules

15 Aug 2023 Design Therapeutics Reports Initial Results from Phase 1 Multiple-Ascending Dose Study of DT-216 for the Treatment of Friedrich Ataxia
14 Aug 2023 FDA Accepts MyMD Pharmaceuticals’ Investigational New Drug Application (IND) for Phase 2 Study of oral TNF-α inhibitor MYMD-1® in Rheumatoid Arthritis (RA)
12 Aug 2023 U.S. FDA Approves AKEEGA™ (Niraparib and Abiraterone Acetate), the First-And-Only Dual Action Tablet for the Treatment of Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer
11 Aug 2023 Sosei Heptares and Cancer Research UK Announce the Dosing of the First Patient in a Phase I/IIa Trial with Cancer Immunotherapy Drug HTL0039732
09 Aug 2023 Cocrystal Pharma Selects Novel Oral Protease Inhibitor CDI-988 as Norovirus Lead
09 Aug 2023 Terns Achieves Primary Endpoint and All Secondary Endpoints in Phase 2a DUET Trial of THR-β Agonist TERN-501 in NASH
09 Aug 2023 Novartis remibrutinib Phase III trials met their primary endpoints and showed rapid symptom control in chronic spontaneous urticaria
09 Aug 2023 Meiji Seika Pharma Announces Positive Results in Phase II Study of ME3183, a Novel Highly-Potent Selective PDE4 Inhibitor, in Patients With Moderate-to-Severe Plaque Psoriasis in the United States and Canada
08 Aug 2023 GRI Bio Presents Encouraging Preclinical Data Indicating Oral Administration of GRI-0803 Inhibited Lupus Nephritis and Significantly Improved Overall Survival in Animal Models
05 Aug 2023 Lilly's Retevmo® (selpercatinib) is the First Targeted Therapy to Demonstrate Superior Progression-Free Survival Compared to a PD-1 Inhibitor Plus Chemotherapy for Adults with Newly-Diagnosed Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung
05 Aug 2023 FDA Approves ZURZUVAE™ (zuranolone), the First and Only Oral Treatment Approved for Women with Postpartum Depression, and Issues a Complete Response Letter for Major Depressive Disorder
04 Aug 2023 Oncternal Therapeutics Receives FDA Study May Proceed Letter for ONCT-534, its Novel Dual-action Androgen Receptor Inhibitor, for the Treatment of Patients with Advanced Prostate Cancer
03 Aug 2023 Inimmune Corporation announces First Subject Dosed in First-in-Human Phase 1 Clinical Trial of its novel intranasal TLR4 agonist, INI-2004, for the Treatment of Allergic Rhinitis and FDA Clearance of IND application for INI-2004
03 Aug 2023 FDA Approves LONSURF® (trifluridine/tipiracil) in Combination With Bevacizumab for Adult Patients With Metastatic Colorectal Cancer (mCRC)
03 Aug 2023 RS Oncology presents new drug in early clinical development for Mesothelioma and lung cancer patients
02 Aug 2023 IDEAYA and Amgen Achieve First-Patient-In for Clinical Evaluation of IDE397 (MAT2A) and AMG 193 (PRMT5(MTA)) Combination in MTAP(-/-) Tumors
01 Aug 2023 Pipeline Therapeutics Announces First Subject Dosed with PIPE-791 in Phase 1 Study
01 Aug 2023 Biosion Announces Phase II Study Start for Anti-TSLP mAb BSI-045B in Atopic Dermatitis (ADAMANT)
01 Aug 2023 Marinus Pharmaceuticals Announces European Commission Approval of ZTALMY® (ganaxolone) for the Adjunctive Treatment of Epileptic Seizures Associated with CDKL5 Deficiency Disorder
01 Aug 2023 MyMD Pharmaceuticals Reports Statistically Significant Positive Topline Phase 2 Results for Next Generation Oral TNF-α Inhibitor MYMD-1® in Sarcopenia/Age-Related Frailty - MYMD-1 significantly reduced serum levels of chronic inflammatory markers and met
01 Aug 2023 Sumitomo Pharma and Otsuka Announce Topline Results from Phase 3 DIAMOND 1 and DIAMOND 2 Clinical Studies Evaluating Ulotaront in Schizophrenia
28 Jul 2023 Avenue Therapeutics Announces First Patient Dosed in Phase 1b/2a Clinical Trial of AJ201 for the Treatment of Spinal and Bulbar Muscular Atrophy (Kennedy's Disease)
28 Jul 2023 UGN-102, in Development as the Potential First Non-Surgical Therapy for LG-IR-NMIBC, Met Primary Endpoints in Both Phase 3 ATLAS and ENVISION Clinical Trials
28 Jul 2023 Cullgen Announces First-In-Human Dose in Phase I/II Trial of CG001419, a First-in-Class TRK Protein Degrader for Treatment of Cancer Patients
26 Jul 2023 Stoke Therapeutics Announces Positive New Safety & Efficacy Data from Patients Treated with STK-001 in the Phase 1/2a Studies (MONARCH & ADMIRAL) and the SWALLOWTAIL Open-Label Extension (OLE) Study in Children and Adolescents with Dravet Syndrome

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