INTELLIGENCE BRIEFThe U.S. Food and Drug Administration (USFDA) granted multiple Abbreviated New Drug Application (ANDA) approvals between 03 and 10 September 2026, covering therapeutic areas including oncology, anticonvulsants, cardiovascular diseases,…
FDA Publishes Draft Guidance on Compounding Animal Drugs from Bulk Drug Substances Authority: U.S. Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM)Document: Draft Guidance for Industry GFI #256BDate:…
The global pharmaceutical landscape is shifting rapidly, driven by strategic generic entries and a clear push toward high-barrier formulations. An analysis of the Abbreviated New Drug Application (ANDA) approvals from…
The U.S. Food and Drug Administration (USFDA) continued its steady pace of generic drug approvals during the first week of June 2026, granting multiple Abbreviated New Drug Application (ANDA) approvals…
Alembic Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Levothyroxine Sodium Tablets USP on 20 May 2026.…
Steranco Healthcare has received approval from the U.S. Food and Drug Administration (USFDA) for Lacosamide through the Abbreviated New Drug Application (ANDA) pathway under application number 220366. This approval marks…
On 21-May2026, Rubicon Research Limited has received approval from the U.S. Food and Drug Administration (USFDA) for its Clonazepam Tablets USP through the Abbreviated New Drug Application (ANDA) pathway under…
Date of Publication: 22-May-2026 INTELLIGENCE OVERVIEWAgency: Bhutan FDAThe Bhutan Food and Drug Authority (BFDA) has released a draft guideline on the Importation, Consignment Verification, and Lot Release of Medical Products…
In the pharmaceutical industry, staying ahead of regulatory updates is a baseline requirement; translating those updates into actionable market intelligence is what drives strategic advantage.Over a brief six-day period mid-month,…
Date of Publication: 20-May-2026 INTELLIGENCE OVERVIEWAgency: USFDAThe FDA has released the ICH M11 Clinical Electronic Structured Harmonized Protocol (CeSHarP) Guidance for Industry, introducing a standardized approach for structuring and electronically…