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Alembic Pharma Receives US FDA Approval for Generic Tretinoin Cream
Alembic Pharmaceuticals has secured final USFDA approval for its generic Tretinoin Cream USP, 0.05 percent, used in the treatment of acne vulgaris, targeting a US market estimated at USD 76 million.
US FDA Classifies Aurobindo Pharma's Eugia Unit-III Inspection as Official Action Indicated
Aurobindo Pharma said the US FDA has classified its inspection of Eugia Unit-III in Telangana as Official Action Indicated, while reaffirming its commitment to maintaining global quality manufacturing standards.
Siemens Healthineers Begins Local Manufacturing of Atellica Chemistry Reagents in India
Siemens Healthineers has commenced local production of Atellica chemistry reagents at its Vadodara plant, enhancing domestic manufacturing capabilities and supporting early disease detection and preventive healthcare in India.
Bayer Secures US FDA Approval for Ambelvist, a Low-Dose MRI Contrast Agent
Bayer’s Ambelvist (gadoquatrane) has received US FDA approval for contrast-enhanced MRI in adults and children, offering effective lesion visualization while reducing gadolinium exposure through a low-dose formulation.
AstraZeneca's Ultomiris Granted FDA Priority Review for Rare Kidney Disease IgAN
The US FDA has granted Priority Review to AstraZeneca’s supplemental application for Ultomiris in immunoglobulin A nephropathy, bringing the therapy closer to becoming the first C5 complement inhibitor approved for the rare kidney disease.
Takeda's Oveporexton Improves Daily Function in Narcolepsy Type 1
Takeda’s phase 3 data show oveporexton improved daily function, cognition, and nighttime sleep in people with narcolepsy type 1. The results support the potential of the first orexin agonist therapy, with regulatory submissions currently under review.
Health Ministry Ends Cough Syrup Sale Exemption in Villages
The Union Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, withdrawing the exemption for cough syrup sales in small villages. The move strengthens regulatory oversight and aims to improve monitoring, safety, and control of cough syrup distribution across India.
US FDA Accepts Gilead's Once-Weekly Yeztugo for HIV Prevention
Gilead’s investigational once-weekly oral HIV prevention pill Yeztugo has been accepted for US FDA review, supported by strong clinical data showing high efficacy of lenacapavir in preventing HIV across 2 clinical trials. The therapy could become the first long-acting oral option for HIV prevention.
Suven Life Sciences Reports Positive Phase 1 Results for SUVN-I6107
Suven Life Sciences has reported positive topline results from the First-in-Human phase 1 study of SUVN-I6107, a Muscarinic M1 Positive Allosteric Modulator (M1-PAM). The successful trial supports the advancement of SUVN-I6107 into phase 2 clinical development.
Celldex Reports Sustained Angioedema Improvement with Barzolvolimab in CSU
Celldex presented long-term data showing barzolvolimab delivered sustained off-treatment improvement in angioedema among patients with Chronic Spontaneous Urticaria (CSU).Treatment with barzolvolimab resulted in rapid, significant, and durable improvements in angioedema in patients with moderate to severe CSU.
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