Curated news and analysis on clinical trials, drug approvals, and medical research.
SCOPE 2026 in Orlando recognized innovation in clinical research with three awards programs, honoring Biogen's lupus webinar series, TrialScreen's site connection initiative, and Biorce's AI platform among 70 competing products.
The FDA approved a once-monthly dosing schedule for Rybrevant Faspro with Lazcluze for first-line treatment of EGFR-mutated advanced NSCLC, reducing clinic visits while maintaining safety and efficacy established with bi-weekly dosing.
Eli Lilly reported positive Phase 3 results for retatrutide showing up to 71.2 lbs average weight loss, while stockpiling $1.5 billion of oral drug orforglipron ahead of anticipated FDA approval in April 2026.
Amgen received FDA and European Commission approval for Uplizna to treat generalized myasthenia gravis in adults who are anti-AChR or anti-MuSK antibody positive, offering twice-yearly maintenance dosing after initial loading doses.
Moderna and Merck announced median five-year follow-up data showing intismeran autogene in combination with Keytruda reduced the risk of melanoma recurrence or death by 49% in high-risk patients following complete resection.
The FDA approved tradipitant (Nereus), an oral NK-1 receptor antagonist, for prevention of motion-induced vomiting on December 30, 2025. The approval marks the first new pharmacologic treatment for motion sickness in over four decades.
The FDA has accepted Celcuity's New Drug Application for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer, granting Priority Review with a PDUFA goal date of July 17, 2026.
Antibody-drug conjugates targeting TROP2 with topoisomerase I inhibitor payloads are currently marketed in breast and lung cancer, with over 100 such ADCs now in clinical trials for various malignancies including gastrointestinal tumors.
The FDA approved Zycubo (copper histidinate) on January 13, 2026, as the first treatment for Menkes disease in pediatric patients, following resolution of manufacturing compliance concerns that led to an initial rejection in September 2025.
The FDA issued a Complete Response Letter for Corcept's relacorilant as a treatment for hypertension secondary to hypercortisolism, requesting additional evidence of effectiveness despite acknowledging positive trial results.
Drug Hunter's monthly molecule selections from July through December 2025 feature innovative small molecule candidates targeting pain, epilepsy, cancer, infectious diseases, and metabolic disorders, including non-opioid pain agents and precision therapies for rare conditions.
Reference materials provide cheat sheets covering pharmacokinetic parameters and medicinal chemistry principles to support medicinal chemists in preclinical drug discovery research.
The FDA accepted Takeda's NDA for oveporexton (TAK-861), an oral orexin receptor 2 agonist for narcolepsy type 1, and granted Priority Review with a PDUFA goal date in Q3 2026. The drug could become the first approved orexin agonist.
The FDA approved 46 novel drugs in 2025, down from 50 in 2024. Small molecules accounted for 31 approvals (67%), with oncology leading at nine approvals. Large molecules contributed 15 approvals (33%), spanning ADCs, bispecifics, and subcutaneous delivery innovations.
Orforglipron, an oral non-peptide GLP-1R partial agonist developed by Chugai and Eli Lilly, has reported positive Phase III data for obesity and type 2 diabetes, representing a shift from injectable peptides to oral small molecules in the GLP-1R space.
CDK4/6 inhibitors have transformed HR+/HER2− breast cancer treatment, while emerging resistance mechanisms are driving development of selective CDK2 inhibitors and dual CDK2/4 strategies to address treatment failure.
Radiopharmaceuticals are emerging as a promising therapeutic class in oncology, with theranostic approaches combining diagnostics and treatment gaining particular attention. Major pharmaceutical companies have invested billions in acquisitions while venture financing reached record levels.
Drug Hunter has opened nominations for the 2025 Molecules of the Year following the announcement of the final Molecules of the Month for 2025. Eligible molecules must have been first disclosed or had a major update in 2025.
A webinar series presented advances in drug discovery technologies, covering chemoproteomic platforms for target identification, AI-driven high-content screening methods, and ADME optimization strategies.
Monthly patent reviews from April through December 2025 highlight notable drug discovery IP disclosures across targeted protein degradation, small molecule modulators, and emerging therapeutic targets in oncology, immunology, and neurology.
