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Recent items include:
- <![CDATA[The Evolving Relationship Between FDA and Biotech]]>
- Three-year biotech policy drafted
- India's biotech push reaches an inflection point, but funding remains the missing piece
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Three-year biotech policy drafted
Policy designed to enhance agricultural output, adopt global farming practices
India's biotech push reaches an inflection point, but funding remains the missing piece
Historically, Indian pharmaceutical companies have focused on generics and services businesses, which carry lower risk and shorter development
A New Approach to Supporting Quality of Biologics
The United States Pharmacopeia (USP) is proposing a new approach for its work to support the quality and availability of selected biologic medicines. Building on decades of experie...
This Startup Aims to Upend Biologic Drug Production With Implantable ‘Cell Factories’
Duracyte’s implants employ cells engineered to produce therapeutic protein, bypassing the complexities of traditional biologics manufacturing. The startup’s marriage of biotechnolo...
USDA Seeks Input on Future Biotechnology Regulation as Agricultural Biologicals Policy Continues to Evolve
On May 15, 2026, the U.S. Department of Agriculture (USDA) published a Request for Information (RFI) seeking public input on the future regulation of genetically engineered (GE) or...
“It’s time to Act”: EU biotech to undergo major changes
The EU Biotech Act is expected to reduce clinical trial timelines, boost biomanufacturing, and most importantly, attract investments. The post “It’s time to Act”: EU biotech to und...
From Discovery to Development in Emerging Modalities
ProBio is building flexible platforms for multispecific antibodies, ADCs, and other advanced therapeutic approaches. The post From Discovery to Development in Emerging Modalities a...
Montana’s SB535 and a Potential Biotech Renaissance in America
In 2024, China’s NMPA approved 83 new drugs, the FDA approved 50. China’s share of new commercial clinical trials jumped from 8% globally in 2013 to 30% in 2024, just behind the US...
The State of Biologics Testing Report 2026
This report is intended to inform discussion and decision making, not to prescribe solutions. Produced in collaboration with GEN, it reflects the collective voice of an industry ad...
Organ-on-a-chip, Organoids, but Drug Testing on Whole Organs? This Startup is Betting On It
Many startups and established companies focused on drug testing on human data in preclinical studies have been boosted by FDA’s move away from reliance on animal testing towards or...
<![CDATA[The Biotech Industry’s Relationship with Real-Time Data: Q&A with Dr. Richard Graham]]>
<![CDATA[Modern Communication Between FDA, Biotech, and Investors: Q&A with David Crean]]>
BridgeBio gets funding for drug launch; United buys into cell therapy
Elsewhere, Otsuka’s kidney drug hit the goal of a confirmatory trial and Vertex’s CRISPR sickle cell drug secured expanded approval.
<![CDATA[Additive Manufacturing's Application in Pharma and Biotech]]>
Next Generation Biopharma Innovation
In a quest to provide more relevant translational data, traditional in vivo models join forces with new approach methodologies. The post Next Generation Biopharma Innovation appear...
Biotech Firm Says It Can Cut Gene Therapy Production Time To One Day
A key claim by the company MedTherapy is a major reduction in production timelines. While gene therapies typically take weeks or months to manufacture, MedTherapy says it has signi...
Plant Expression Platforms May Be Better Option for Biopharma in the Global South
Mammalian cell-based biopharmaceutical manufacturing systems are complex, expensive, and, say the authors of a new study, not suited to producing medicines in resource-constrained...
Major Biopharmaceutical Company Files First-in-Human Trial Supported by PAK BioSolutions GMP Purification System
A major biopharmaceutical company has filed a First-in-Human (FIH) clinical trial application with drug product manufactured using the PAK BioSolutions system. The milestone demons...
<![CDATA[Chai Discovery Enters License Agreement with Pfizer to Accelerate Drug Discovery with AI]]>
A Billion-Dollar Deal, Trial Trouble, Biohub Updates, and Vaccine Research News
In this episode of GEN's Touching Base, editors discuss a variety of news including the halt of a lead pipeline program at Fulcrum Therapeutics, a new multibillion dollar collab, p...
<![CDATA[New FDA Draft Guidance Targets Gene Therapy Submission Burden by Allowing Use of Existing CMC and Scientific...
WuXi AppTec’s 1260H Listing Brings the BIOSECURE Act Back to Center Stage
By Steven J. Gonzalez —
<![CDATA[Pharmaceutical Executive Daily: FDA Approves Utebzi and Capvaxive]]>
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