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BioWorld - Saturday, March 28, 2026
Home » Topics » Regulatory

Regulatory
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China and U.S. flags

China’s pharma rise rattles US policymakers

March 24, 2026
By Tamra Sami
No Comments
U.S. lawmakers and industry experts are raising alarm over China’s expanding dominance across the pharmaceutical supply chain, warning that reliance on Chinese inputs poses a growing national security and public health risk.
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Hand holding money plant

Wait almost over, as SBIR nears reauthorization

March 24, 2026
By Mari Serebrov
No Comments
A five-year reauthorization of the U.S. Small Business Innovation Research (SBIR) and Small Business Technology Transfer programs is just the president’s signature, or a few days, away.
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Gynecology/obstetrics

Endocyclic’s ENDO-205 gains IND clearance for endometriosis

March 24, 2026
No Comments
Endomet Biosciences Inc. (dba Endocyclic Therapeutics) has obtained IND clearance from the FDA for its lead program, ENDO-205, a first-in-class, nonhormonal targeted peptide therapeutic for endometriosis.
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3D illustration demonstrating antibody-drug conjugate.
Immuno-oncology

Kelun-Biotech’s SKB-103 cleared to enter clinic in China

March 24, 2026
No Comments
Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. has announced IND approval by China’s National Medical Products Administration (NMPA) for SKB-103 for the treatment of advanced solid tumors.
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Architectural pillars

US Supreme Court says no to Takeda class action challenge

March 23, 2026
By Mari Serebrov
No Comments
Crushing the hopes of drug and device companies, the U.S. Supreme Court’s March 23 orders list showed it denied cert in Takeda Pharmaceutical v. Painters & Allied Trades, which sought to rein in the expansion of class action lawsuits.
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Boston Scientific Cryoablation System

NICE issues guidance to improve kidney cancer care

March 23, 2026
By Shani Alexander
No Comments
With incidence of kidney cancer rising in the U.K., the National Institute for Health and Care Excellence (NICE) published its first comprehensive guidelines for diagnosing and treating the disease.
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FDA approved metal stamp
Biopharma approvals February 2026

US FDA clears four NMEs, including those for dermatitis, achondroplasia

March 20, 2026
By Amanda Lanier
No Comments
Drug approvals by the U.S. FDA totaled 26 in the first two months of 2026, with eight approvals in January and 18 in February. Compared with 2025, when approvals reached 12 in January and 16 in February (28 total), early 2026 activity is consistent with historical ranges.
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NIH Director Jay Bhattacharya

US lawmakers to Bhattacharya: Explain your answers

March 20, 2026
By Mari Serebrov
No Comments
NIH Director Jay Bhattacharya is being fact-checked on his off-the cuff responses at a Senate Health, Education, Labor and Pensions Committee hearing in February. The fact-checkers are nine Democratic lawmakers from Massachusetts, only one of whom (Sen. Ed Markey) is on the committee and attended the hearing. In fact, seven of those signing the March 17 letter that questioned Bhattacharya’s veracity aren’t senators. They serve in the House.
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Light bulb shines next to extinguished ones

Australia’s R&D reset puts biotech translation in focus

March 20, 2026
By Tamra Sami
No Comments
Australia is attempting a once-in-a-generation reset of its innovation system, and biotech industry leaders have lauded the federal government’s independent review into Australia's slipping R&D ranks and its proposals to reverse the decline.
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Lab mouse and test tubes
Drug design, drug delivery & technologies

FDA, NIH mark milestones toward reducing animal testing

March 20, 2026
By Mari Serebrov
No Comments
In what the U.S. FDA has dubbed a milestone move toward fewer animal studies in drug development, the agency published a draft guidance to help sponsors validate new approach methodologies that can bring safe, effective drugs to market sooner based on human-centric data rather than starting off with nonclinical animal pharmacology and toxicology data.
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