Will an AI-Designed Drug Receive Regulatory Approval by 2030?

Ascletis Announces Initiation of Global Phase III for Oral Small Molecule GLP-1, ASC30 and Positive Preclinical Data for Its First-in-Class Oral Small Molecule GLP-1/GIP/Amylin Fixed-Dose Combination - Siam News Network

Ascletis announced FDA clearance and global initiation of Phase III for its once-daily oral GLP-1 ASC30 (aimed at obesity/overweight) spanning about 4,600 participants in two pivotal trials, plus positive preclinical data for a first-in-class oral GLP-1/GIP/amylin fixed-dose combination, positioning the company with a comprehensive one-pill oral obesity portfolio.

FDA's Historic Drug Approvals: A Game-Changer for Oncology, Cardiology, and More (2026)

The article highlights a wave of FDA drug approvals across oncology, cardiology, rare genetic disorders, and neurology—introducing genotype-targeted cancer therapies, AI-assisted heart-failure dosing, a gene therapy for a rare muscular dystrophy, and a drug slowing Alzheimer’s progression—while raising concerns about high costs, patient autonomy, societal and ethical implications, and the widening access gap as healthcare and economic systems adapt to these innovations.

Drug Discovery Has No Magic Wands - by Daphne Koller - a16z

AI in drug discovery is not a magic wand: it can accelerate biology-driven understanding and smarter trials, but only by tackling the hard problem of identifying disease-transforming biological mechanisms; otherwise, speeding up preclinical and clinical steps yields faster failures if the underlying targets are wrong.

FDA Approves Meitheal Garzulys NovoLog Biosimilar

FDA approved Garzulys (insulin aspart-fsan), a NovoLog biosimilar rapid-acting insulin for glycemic control in adults and pediatric diabetes patients, with subcutaneous and intravenous administration, holder Emerge Bioscience and exclusive U.S. commercialization by Meitheal under a 2023 collaboration, announced July 30, 2026; launch date, price, and interchangeability were not disclosed.

Ascletis Announces Initiation of Global Phase III for Oral Small Molecule GLP-1, ASC30 and Positive Preclinical Data for Its First-in-Class Oral Small Molecule GLP-1/GIP/Amylin Fixed-Dose Combination | lifestyle.trondstidkontroll.com

Ascletis has initiated global Phase III trials for its once-daily oral GLP-1 candidate ASC30 (about 4,600 participants across the U.S., Europe, and Canada, with NDA/MAA filings planned by 2028–2029) and announced positive preclinical data for a first-in-class oral GLP-1/GIP/amylin fixed-dose combination, expanding its oral obesity portfolio.

What would it take to get peptides on the shelf?

The FDA advisory panel approved most of seven peptide therapies for potential production by compounding pharmacies, despite agency safety concerns, but final approval and implementation remain uncertain and could involve interim steps like placing them on a Category One list, with access likely delayed and limited to prescription, compounding-pharmacy channels rather than standard pharmacies.

Biotech leaders call for streamlining of INDs as FDA’s Trialblazer rolls out - BioSpace

Biotech leaders welcome HHS’s Operation TrialBlazer and FDA’s new rolling IND submissions to speed first-in-human trials, with plans to streamline IND requirements, expand pre-IND consultative meetings, and pursue a single-IRB model across sites, all aimed at shaving up to a year from early-phase development while coordinating across CDER, CBER, and other HHS agencies.

What would it take to get peptides on the shelf?

The FDA advisory panel backed seven peptide therapies for production by compounding pharmacies (except one), signaling potential future access while the agency weighs safety and lacking robust human trial data, with final decisions and interim availability likely to unfold over months.

Ascletis Announces Initiation of Global Phase III for Oral Small Molecule GLP-1, ASC30 and Positive Preclinical Data for Its First-in-Class Oral Small Molecule GLP-1/GIP/Amylin Fixed-Dose Combination

Ascletis announced the initiation of a global Phase III program for its once-daily oral GLP-1 candidate ASC30 (about 4,600 participants across the U.S., Europe, and Canada) for obesity/overweight, plus positive preclinical data for a first-in-class oral GLP-1/GIP/amylin fixed-dose combination, positioning a comprehensive one-pill obesity portfolio with expected topline results in 2028 and potential NDA/MAA filings thereafter.

U.S. FDA Grants Orphan Drug Designation to Zai Lab’s DLL3-Targeting ADC Zocilurtatug Pelitecan (Zoci) for the Treatment of Neuroendocrine Carcinomas (NECs)

The FDA has granted Orphan Drug Designation to Zai Lab’s DLL3-targeting ADC Zocilurtatug Pelitecan (Zoci) for neuroendocrine carcinomas, adding regulatory incentives and marking a potential first-in-class therapy as Zoci advances toward registration-enabling studies across SCLC and extrapulmonary NECs.