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10 Approvals To Look Out For In Q3 2023

 
• By Alexandra Shimmings

The third quarter could bring US approvals for a range of novel drugs, including the first treatment for a common eye disease, the first US approval of PD-1/L1 inhibitor from a Chinese firm, and the first oral therapy for postpartum depression.

• Source: Shutterstock

PDUFA for NDA - Second Review 24 July

Despite launching the product as Vanflyta in 2019, Daiichi Sankyo Co., Ltd. has been waiting a long time for US approval of quizartinib, its oral FLT3 kinase inhibitor, for...

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Bayer Has BI In Its Sights With Priority Review For HER2 Lung Cancer Drug

 
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Sevabertinib gets onto the FDA's approval fast track three months after zongertinib.

Pipeline Watch: 12 Approvals And 26 Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Boehringer’s CMO On How AI, Integrated Evidence Generation Underpin Its Ambitious Launch Plans

 
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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

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All Over For iTeos But Applause For Plan To Return Cash Fast

 
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The company has moved quickly to wind down operations after its anti-TIGIT pact with GSK collapsed.

Loss Of Exclusivity Product Launches To Fuel Aurobindo’s FY26 Europe Growth

 
• By Vibha Ravi

Aurobindo is banking on launches of loss of exclusivity products and biosimilars to fuel sales in Europe as it awaits a US announcement on tariffs and predicts high single-digit growth overall during FY26 for now

Korea Q1 Roundup: Mixed Earnings, Gearing For Possible US Tariffs

 
• By Jung Won Shin

South Korean biopharma companies report a mostly solid first quarter, marked by US growth for original drugs, with several also making preparations for possible US pharma tariffs.