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Suven Life Sciences Announces 3 Poster Presentations on Samelisant
Suven Life Sciences showcases 3 posters on Samelisant (SUVN-G3031), including findings from the global phase 3 AWAKE Narcolepsy Study at SLEEP 2026.
Alembic Pharmaceuticals Announces US FDA Final Approval for Tretinoin Cream
Alembic Pharmaceuticals has received US Food and Drug Administration (FDA) final approval for Tretinoin Cream USP, 0.05 percent, a generic version of Bausch Health’s Retin-A Cream.
Teva Completes Acquisition of Emalex Biosciences
Teva has completed its acquisition of Emalex Biosciences, strengthening its late-stage neuroscience pipeline. The deal supports Teva’s Pivot to Growth strategy.
India Poised to Become a Global Biopharma Leader: Anupriya Patel
Union Minister Anupriya Patel said India is well-positioned to become a global biopharma leader, highlighting the Biopharma SHAKTI initiative’s goal of launching 100 biologics by 2047. She urged the industry to strengthen capabilities in biologics and biosimilars.
CDSCO Approves AstraZeneca's Trastuzumab Deruxtecan Plus Pertuzumab Combination
AstraZeneca Pharma India has received CDSCO approval for trastuzumab deruxtecan plus pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer.
Del-Brax from Novartis Achieves Primary Biomarker Endpoint in FSHD Study
Novartis reported positive phase 1/2 FORTITUDE study results for delpacibart braxlosiran (del-brax) in FSHD, meeting primary and key secondary biomarker endpoints. The therapy could become the first disease-modifying treatment for FSHD, with a phase 3 trial underway.
Ono Pharma Seeks Expanded OPDIVO Use for Anaplastic Thyroid Cancer in Japan
Ono Pharma seeks expanded approval for OPDIVO in Japan for unresectable anaplastic thyroid cancer after a trial with Lenvima met its primary endpoint.
IP 2026 Conclave Highlights Pharmacopoeial Standards for Pharma Quality
The Indian Pharmacopoeia Commission (IPC) strengthens industry preparedness for IP 2026 through awareness, capacity-building, stakeholder engagement, and adoption of pharmacopoeial standards for quality-assured medicines.
EMA Confirms Asundexian MAA for Assessment in Secondary Prevention of Ischemic Stroke
The EMA has accepted the Marketing Authorisation Application (MAA) for asundexian, the first Factor XIa (FXIa) inhibitor under review in Europe for secondary prevention of ischemic stroke. The submission is supported by positive phase 3 OCEANIC-STROKE data.
PharmaEssentia Secures Taiwan Approval for BESREMi in Essential Thrombocythemia
PharmaEssentia has received Taiwan approval for BESREMi as the first globally approved treatment for Essential Thrombocythemia (ET), marking the first new approved therapy for the disease in nearly 30 years.
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