Regulatory Authority: U.S. Food and Drug Administration (USFDA)Regulatory Event: BLA Approval – InterchangeabilityProduct: Garzulys (insulin aspart-fsan) injectionBLA: 761497/Original 2Approval Date: September 15, 2026Reference ID: 5869336 Regulatory Update The U.S. Food…
Seven Indian pharmaceutical companies received product approvals from the United States Food and Drug Administration (USFDA) between 3 September and 10 September 2026. The approvals cover products across dermatology, cardiovascular…
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,…
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…
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: 13-Mar-2026 INTELLIGENCE OVERVIEWAgency: EMAThe European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recently concluded a safety review regarding Ixchiq, a live attenuated vaccine used to prevent…