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Apr 06, 2026
FDA said in early February 2026 that it is taking issue with “same active ingredient” claims in compounded drug advertising. The stance contrasts with longstanding agency frameworks for active ingredient sameness in generics and compounding.
Apr 06, 2026
Alterity is preparing for a mid-2026 end-of-Phase II FDA meeting for ATH434 in Multiple System Atrophy. Phase II data showed clinically meaningful and statistically significant effects, with safety comparable to placebo.
Apr 05, 2026
Scientists are testing experimental cancer therapies including mRNA therapeutic vaccines, engineered EcN bacteria that deliver romidepsin in mice, and macrophage-targeted CAR T cells.
Apr 04, 2026
Krystal Biotech is set to report fourth-quarter results with analysts expecting $1.58 a share on $106.16 million in revenue. Investors are watching Vyjuvek growth and pipeline programs including KB801, KB407 and KB707.
Apr 03, 2026
Researchers have engineered immune cells to sense cancer metabolites, improving tumor infiltration in solid cancers. Separate studies identify Kappa and Lambda Myeloma Antigens as specific targets for multiple myeloma treatment, while mRNA-based personalized cancer vaccines show promise through AI-driven neoantigen selection.
Apr 03, 2026
Final phase 3 trial results show atrasentan (Vanrafia®) provides significant long-term kidney function benefits in IgA nephropathy patients, with a 2.59 mL/min/1.73m² eGFR improvement versus placebo. Earlier phase 2 data demonstrated the drug reduces proteinuria by 30.7% when added to standard background therapy. The drug's manufacturer plans to seek traditional FDA approval in 2026 based on these findings.
Apr 03, 2026
A phase 3 clinical trial has launched for pridopidine as a potential ALS treatment, while AI research identified 18 FDA-approved drugs that may extend survival. Separate studies found a promising three-drug combination for sporadic ALS using new cell models.
Apr 03, 2026
The FDA has approved nivolumab with chemotherapy for pediatric and adult Hodgkin lymphoma patients aged 12+, based on clinical trial data showing improved survival. Separately, the agency cleared investigational new drug applications for FG001 for brain cancer surgery visualization and FRF-001 gene therapy for FOXG1 syndrome, allowing both to proceed to clinical trials.
Apr 03, 2026
Revolution Medicines has initiated patient treatment in the Phase 3 RASolute 303 trial testing daraxonrasib as first-line therapy for metastatic pancreatic cancer. The company also expects top-line data from its Phase 3 RASolute 302 trial in second-line pancreatic cancer in the first half of 2026. Both trials are evaluating the oral RAS(ON) inhibitor in pancreatic ductal adenocarcinoma, a highly lethal cancer with significant unmet medical need.
Apr 03, 2026
Ocugen has completed enrollment and dosing in its phase II/III GARDian3 study for OCU410ST gene therapy targeting Stargardt disease. The study includes 63 patients and aims to address over 1,200 ABCA4 gene mutations with a single treatment. Interim data is expected in Q3 2026, with a BLA submission targeted for mid-2027.
Apr 03, 2026
The FDA has granted orphan drug designation to Nuformix PLC's tranilast lysate candidate for treating idiopathic pulmonary fibrosis. The designation provides regulatory incentives including potential market exclusivity in the US. Nuformix is a London-based developer focused on fibrosis and oncology treatments.
Apr 02, 2026
Lipocine's oral postpartum depression drug LPCN 1154 failed to meet its primary endpoint in a Phase 3 trial involving 90 patients. However, a post hoc analysis showed clinically meaningful improvements in a subset of 54 patients with psychiatric history, and the drug demonstrated a favorable safety profile supporting outpatient use.
Apr 02, 2026
Class action lawsuits allege securities violations by Atara Biotherapeutics and Inovio Pharmaceuticals related to FDA submissions. Atara faces claims over manufacturing issues with its tabelecleucel BLA, while Inovio is accused of misleading statements about INO-3107 regulatory timelines and manufacturing deficiencies.
Apr 02, 2026
Adagene and Incyte will collaborate on a Phase 1 study combining muzastotug with INCA33890 for MSS colorectal cancer patients, beginning in 2026. The collaboration marks the second instance where Adagene's SAFEbody technology is paired with a PD-1-based bispecific. Muzastotug has shown encouraging response rates in combination with pembrolizumab in previous trials.
Apr 02, 2026
The FDA has granted Fast Track designation to Cocrystal Pharma's oral antiviral CDI-988 for norovirus prevention and treatment. A Phase 1b norovirus challenge study is underway at Emory University, with data to be presented at an international antiviral research conference in April 2026.
Apr 02, 2026
FDA has cleared a robotic nipple-sparing mastectomy platform after clinical trials showed excellent results with preserved breast sensation. Researchers are advancing immunotherapy combinations for breast cancer and novel strategies to overcome drug resistance in EGFR-mutated lung cancer, including protein degraders and dual-binding inhibitors.
Apr 02, 2026
Phase 3 trial results show seralutinib missed its primary endpoint in PAH but showed benefit in advanced disease subgroups. Meanwhile, Winrevair demonstrated significant reductions in pulmonary vascular resistance in heart failure-related pulmonary hypertension in a Phase 2 study.
Apr 02, 2026
The FDA will drop its longtime requirement for two rigorous studies to approve new drugs, moving to a default position of requiring only one study. Commissioner Marty Makary says the change reflects modern scientific advances and aims to accelerate drug availability without compromising safety. The shift follows decades of increasing flexibility for rare and fatal diseases, with about 60% of first-of-a-kind drugs already approved based on single studies in recent years.
Apr 01, 2026
Medivir's 2025 Annual Report highlights FDA Orphan Drug Designation for MIV-711 in Osteogenesis Imperfecta and promising fostrox liver cancer data showing 13.7-month median survival. The company raised SEK 196 million to fund Phase 2 studies for both programs and reported year-end cash of SEK 119.2 million.
Apr 02, 2026
Pharmaceutical M&A is shifting toward late-stage clinical assets with proven human data, particularly in GLP-1 obesity drugs, oncology, and central nervous system disorders. Companies like Viking Therapeutics, Structure Therapeutics, and Revolution Medicines represent compelling acquisition targets with advanced clinical programs. This trend reflects industry prioritization of de-risked assets that can accelerate commercialization pathways.
