FDA Flags CGMP Failures at Alchymars ICM SM Over API Quality
U.S. regulators cite Alchymars ICM SM Private Limited for CGMP violations tied to active pharmaceutical ingredient quality and potential adulteration.
Tag • 19 articles
Therapy Access
Articles currently tagged Therapy Access.
FDA Highlights First Generic Drug Approvals for 2025
The FDA’s drug center has published its early list of 2025 first generic approvals, a key marker for when lower-cost versions of brand medicines can reach patients.
FDA Withdrawn Oncology Accelerated Approvals: What the Move Signals
The FDA has listed certain cancer accelerated approvals as withdrawn. Here is what that means now, and why formal confirmation in the next week is uncertain.
FDA Clears Enhertu for Two Uses in Early HER2-Positive Breast Cancer
Regulators grant dual approvals for fam-trastuzumab deruxtecan-nxki in adults with early-stage HER2-positive breast cancer, expanding treatment options.
FDA Clears Two New Uses for T-DXd in Early HER2-Positive Breast Cancer
The FDA has approved two indications for trastuzumab deruxtecan in early HER2-positive breast cancer. Here is what that means and what remains uncertain.
What the FDA’s Drugs@FDA Data Files Reveal—and What Comes Next
The FDA’s Drugs@FDA Data Files open a structured window into approved drugs. Here’s what the new ZIP, data definitions, and ERD actually change.
What FDA’s 503A Bulk Drug Rules Mean for Compounded Medicines
FDA tightens which bulk substances can be used in 503A compounding, shaping what customized medicines pharmacies may legally prepare for patients.
FDA Converts Select Cancer Drugs From Accelerated to Traditional Approval
The FDA has confirmed clinical benefit for several cancer drugs first cleared under its accelerated approval pathway, converting them to traditional approvals.
What the FDA’s Drugs@FDA Data Files Reveal—and What They Don’t Yet Settle
The FDA’s Drugs@FDA Data Files offer a structured view of drug approvals. Here is what is now available, and why firm conclusions should wait for more evidence.
What the FDA’s Expanded Selumetinib Approval Means for Young NF1 Patients
The FDA has extended selumetinib’s use to NF1 patients as young as 1. Here is what is confirmed, what is still thinly documented, and why timing matters.
FDA’s Withdrawn Accelerated Cancer Approvals: What Is Really Known Now
An FDA list shows certain accelerated oncology approvals have been withdrawn. Evidence is thin on next steps, leaving key questions about timing and impact.
How FDA’s CDER SBIA Guides Small Drug Firms Through Regulation
FDA’s CDER Small Business and Industry Assistance program helps small drug companies navigate complex human drug regulations and FDA resources.
Showing 12 of 19 articles
