The US FDA completed a pre-license inspection of Biocon Biologics’ biosimilars manufacturing site at Biocon Park between April 20 and April 29, 2026
Fresenius Kabi's approved generic therapy addresses acute symptomatic hypocalcemia and targets a US market valued at nearly $71 million
Approval expands Lupin’s specialty portfolio in the US market for treatment of urea cycle disorders
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3 to 6 against recommending camizestrant in combination with a CDK4/6 inhibitor
The US regulator conducted an inspection at the Amaliya manufacturing plant between April 20 and May 1, 2026
The Committee backed the combination based on results from the CAPItello-281 Phase III trial, marking a key milestone in the regulatory pathway for AstraZeneca’s targeted therapy strategy in prostate cancer
The move puts a spotlight on one of psychiatry’s most persistent clinical challenges: misdiagnosis and delay
The renewal covers two versions of the IQOS device and three HEETS tobacco variants
Patalganga plant received zero observation from USFDA earlier
The Puducherry facility, dedicated to Ibuprofen and its derivatives, is equipped with advanced infrastructure to serve both domestic and international markets
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