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BioWorld - Wednesday, June 10, 2026
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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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Minimed Flex system

Minimed secures FDA nod for next-gen insulin pump

March 19, 2026
By Shani Alexander
No Comments
Minimed Group Inc. secured U.S. FDA approval for Minimed Flex, its next-generation discreet, smartphone-controlled insulin pump. The nod from the FDA follows the company’s debut on Nasdaq March 6. About half the size of the Minimed 780G pump and roughly the size of two stacked insulin vials, the screenless pump was designed in collaboration with people living with diabetes to offer a more intuitive, lifestyle‑friendly way to manage the condition.
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Red wooden approved stamp

GSK’s IBAT inhibitor wins US FDA nod for cholestatic pruritus

March 19, 2026
By Karen Carey
No Comments
With the U.S. FDA’s approval of GSK plc’s ileal bile acid transporter (IBAT) inhibitor, Lynavoy (linerixibat), patients with primary biliary cholangitis no longer need off-label treatments for a debilitating internal itch symptom called cholestatic pruritus.
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Lab mouse and test tubes

FDA, NIH mark milestones toward reducing animal testing

March 19, 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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Legal scales and clipboard

340B provider finds new way into court over Rx price disputes

March 18, 2026
By Mari Serebrov
No Comments
Even though case law has established that 340B-covered providers can’t sue drug companies for overcharging on the steeply discounted drugs, the Adventist Health System of West tried a new door into court – as a whistleblower under the False Claims Act.
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Icotyde

Icotyde’s in; wave of switchers to oral psoriasis Protagonist?

March 18, 2026
By Randy Osborne
No Comments
Awaiting the potential U.S. FDA approval of a second product this year, Protagonist Therapeutics Inc. with partner Johnson & Johnson won the go-ahead for oral peptide Icotyde (icotrokinra), an IL-23 receptor antagonist, to treat moderate to severe plaque psoriasis in adults and pediatric patients 12 and older who weigh at least 40 kg and who are candidates for systemic therapy or phototherapy.
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Close up of man's eye

Aldeyra collects third CRL for reproxalap in dry eye disease

March 17, 2026
No Comments
It’s déjà vu all over again for Aldeyra Therapeutics Inc., which disclosed its third complete response letter (CRL) for dry eye disease candidate reproxalap, with the U.S. FDA citing a lack of substantial and consistent evidence of efficacy.
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