BioSpace News Archive

Sponsored by Sino Biological

Advances in RSV Vaccine Research and Development

Epidemiology, Next-Generation Vaccine Platforms, and the Critical Role of Prefusion F Antigens in RSV Research

May 11, 2026

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7 min read

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Cardiovascular

Merck, Amgen double down on bad cholesterol to vanquish number 1 killer

New guidelines from two leading medical associations suggest that efforts to reduce bad cholesterol should focus on maintaining low levels of two key lipoproteins. Big pharma is all in, looking to improve on the standard statins to help vanquish America’s number one killer: heart disease.

May 11, 2026

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6 min read

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Ben Hargreaves

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Complete response letters

Published FDA rejections point to manufacturing, data gaps as key stumbling blocks

The FDA’s decision last year to make complete response letters public provides new insight into why therapies sometimes fail to get the regulatory greenlight. Analysts say the information could help sponsors refine their regulatory strategies.

May 11, 2026

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8 min read

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Tristan Manalac

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Approvals

Partner’s Bizengri cleared by FDA for ultra-rare cancer days after winning priority voucher

Partner Therapeutics announced last week that the FDA had granted Bizengri a Commissioner’s National Priority Voucher to accelerate drug review.

May 11, 2026

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2 min read

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Tristan Manalac

Government

Makary’s reported FDA removal could be ‘broad positive’ for biopharma

The widely covered impending ouster of FDA Commissioner Marty Makary not long after the exit of controversial biologics head Vinay Prasad highlights the severe turnover rates at the highest rungs of leadership at the health department.

May 11, 2026

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3 min read

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Tristan Manalac

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Earnings

Daiichi takes $850M charge, axes facility investment as ADC demand forecast falls

While Daiichi Sankyo brought in $13.4 billion in 2025, setbacks forced the company to update its antibody-drug conjugate forecast, pushing demand below the minimum supply agreed upon with CMOs and prompting the cancellation of an in-house investment.

May 11, 2026

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2 min read

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Nick Paul Taylor

Press Releases

Almirall Continues Its Positive Trajectory in Q1 2026 in Line With Expectations – Led by 19.3% YoY Growth of Its European Dermatology Business

May 11, 2026

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8 min read

Press Releases

Innovent Announces IBI363 (PD-1/IL-2α-bias Bispecific Fusion Protein) Received Third NMPA Breakthrough Therapy Designation for MSS/pMMR Metastatic Colorectal Cancer