FDA approval supported by data from BRAVE-AA-PEDS, the first and largest Phase 3 study specifically designed to evaluate pediatric patients with severe alopecia areata (AA) Treatment with Olumiant resulted in substantial scalp hair regrowth, as well as improvements in eyebrows and eyelashes Severe AA can result in extensive hair loss during adolescence, a formative stage of life Sept. 25, 2026 -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA)

Five-year NIH-funded program supports preclinical research, drug product manufacturing, regulatory preparation, and planned clinical studies, advancing MTTI’s EvaThera™ platform and oncology pipeline Molecular Targeting Technologies, Inc. (MTTI), a clinical-stage radiopharmaceutical company, today announced that it has been awarded a $3.17 million, five-year National Cancer Institute (NCI) grant to advance the development of ¹⁷⁷Lu-EBRGD, an investigational radiopharmaceutical targeting integrin

Anthropic has released some early findings that suggest its AI may be able to help researchers sift through the vast and expanding universe of genomic data to uncover previously hidden biology. "Today we announced the Claude-led discovery of a molecular machine that we suspect could represent a new gene editing mechanism," CEO Dario Amodei posted on social media Wednesday. "Its precise function, biotechnological utility (if any), or level of significance is not yet clear, but at minimum it is w

Primary Endpoint Achieved in CBL-0202DD Phase 2 Trial—CBL-514 delivered statistically significant pain reduction across both FAS and PP populations compared with placebo. Expansion Opportunity Beyond Dercum's Disease—Study findings support the potential development of CBL-514 for Lipedema, a condition affecting approximately 10% of women globally and representing a market opportunity of more than US$30 billion. Sept. 22, 2026 -- Caliway Biopharmaceuticals (TWSE: 6919) on September 21 announced

MAIA Biotechnology Expands Pivotal Phase 3 THIO-104 Non-Small Cell Lung Cancer Trial into Spain and Portugal THIO-104 advances toward key 2027 interim survival analysis Sept. 23, 2026 -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing immunotherapies for cancer, today announced that it has received regulatory approval by the Spanish Agency for Medicines and Medical Devices (AEMPS) and Portugal’s National A

SK pharmteco and GEMMABio Expand Rare Disease Manufacturing Collaboration Following Important Spinal Muscular Atrophy (SMA) Clinical Trial Milestone First patient dosed marks an important step for the SMA community and highlights a growing rare disease manufacturing partnership, with future GEMMABio programs expected to leverage SK pharmteco’s SKyvec™ viral vector platform Sept. 22, 2026 -- SK pharmteco announced today it has been working with Gemma Biotherapeutics (“GEMMABio”), a clinical-sta

Designation enhances Kedrion's development program for QIVIGY® and represents an important milestone for patients with Stiff Person Syndrome Sept. 22, 2026 -- Kedrion Biopharma announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Immune globulin intravenous, human 10% solution (tradename QIVIGY®) for the treatment of Stiff Person Syndrome (SPS), a rare and often disabling neurological disorder estimated to affect approximately two per 100,000 people.

Envisagenics’ platform makes use of AI to screen and detect cancer-specific RNA alterations, which Boehringer Ingelheim wants to target through various precision treatment modalities, including multi-specific antibodies, antibody-drug conjugates and T cell engagers. Boehringer Ingelheim is partnering with Envisagenics to leverage the biotech’s AI-forward approach to RNA splicing—a particular molecular alteration in cancer that the companies claim is “one of the last largely untapped sources” of

The medtech rumor mill is churning with speculation that GE HealthCare may be in M&A talks with Sofie Biosciences. Citing “people familiar with the matter,” the Financial Times reported that GE HealthCare could pay up to $1 billion for Sofie. Dulles, VA-based Sofie Biosciences develops and delivers molecular diagnostics and therapeutics (theranostics). During Wells Fargo’s annual healthcare conference last week, GE HealthCare CEO Peter Arduini said the company believes there are "some good oppor

– Completion of BLA submission expected in Q4 2026 – Sept. 21, 2026 -- PTC Therapeutics, Inc., (NASDAQ: PTCT) today announced that it completed the previously announced agreement with Sangamo Therapeutics, Inc. to acquire ST-920 – a BLA-stage, one-time administered AAV gene therapy for Fabry disease. A rolling BLA submission to FDA for accelerated approval of ST-920 is expected to be completed in Q4 2026. "Our team looks forward to completing the ST-920 BLA submission and potentially bringing