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Home » Topics » Regulatory

Regulatory
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MHRA logo

UK’s MHRA opens second round in AI airlock program

June 23, 2025
By Mark McCarty
The U.K. Medicines and Healthcare Products Regulatory Agency opened a second round in its AI airlock program although this round, like the first round, will be limited to four applicants.
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FDA Approved stamp with blister pack
Biopharma regulatory actions and approvals May 2025

Novavax jumps 15% on COVID shot nod, among 14 FDA approvals in May

June 23, 2025
By Amanda Lanier
No Comments
The U.S. FDA approved 14 drugs in May, a decline from 20 in April and 22 in March. That brings the year-to-date total for 2025 to 84 approvals, the second highest on record for this period, just behind the 89 approvals recorded in the first five months of 2024.
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Syringe in spotlight

Under new management, ACIP faces intense scrutiny

June 23, 2025
By Mari Serebrov
No Comments
The June 25-26 meeting of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) will be anything but business as usual. In wiping the slate clean just two weeks before the panel was to meet, Health and Human Services Secretary Robert Kennedy made sure of that.
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3D illustration showing presence of tumor inside prostate gland
Cancer

Archeus gains IND clearance for ART-101 in prostate cancer

June 23, 2025
No Comments
Archeus Technologies Inc. has obtained IND clearance from the FDA for ART-101, a novel receptor-based targeting small molecule for the imaging and treatment of prostate cancer.
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BIO2025: John Crowley and Martin Makary
BIO 2025

Makary lays out FDA’s path, launches pilot review program

June 20, 2025
By Karen Carey
No Comments
On the same day that FDA Commissioner Martin Makary spoke in a fireside chat during the 2025 Biotechnology Innovation Organization’s International Convention, the agency unveiled a pilot commissioner’s national priority voucher program that will enable companies to receive a shortened FDA review time of one to two months.
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FDA icons

FDA scrutinizing trials sending US patient cells to China

June 20, 2025
By Mari Serebrov
No Comments
Using informed consent to do what Congress couldn’t, the U.S. FDA is flexing its regulatory authority to halt clinical trials that involve sending cells from American patients to China or other adversarial nations for genetic engineering and subsequent infusion back into the patient.
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Rezdiffra

CHMP recommends approval of Rezdiffra, Ogsiveo and others

June 20, 2025
By Nuala Moran
No Comments
One year after the FDA’s nod, the EMA is following on and recommending conditional approval of Madrigal Pharmaceuticals Inc.’s Rezdiffra (resmetirom) as the first drug in Europe for treating noncirrhotic metabolic dysfunction-associated steatohepatitis.
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CBER shakeup points to further FDA realignment

June 20, 2025
By Lee Landenberger
No Comments
The realignment within the U.S. FDA continued with reports of the removal of two high level executives. When asked by BioWorld if the Center for Biologics Evaluation and Research’s (CBER) Office of Therapeutic Products director and deputy director had been forced out and if so, why, an HHS spokesperson responded on background with a single sentence: “Center directors deserve to be supported by managers that are aligned with aggressive goals to expeditiously advance therapeutics for rare diseases using the gold standard of science.”
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Brain, syringe hovering over hands

NICE rejects Lilly‘s Kisunla and Eisai‘s Leqembi

June 20, 2025
By Nuala Moran
No Comments
To no great surprise, the U.K.’s health technology assessment body has found that the benefits of the first two approved Alzheimer’s disease drugs are too small to justify the costs. Neither Kisunla (donanemab, Eli Lilly and Co. Inc.) or Leqembi (lecanemab, Eisai Co. Ltd.), “demonstrate sufficient benefit to justify their high cost, including the cost of administering them,” the National Institute of Health and Care Excellence (NICE) concluded after an extended appraisal of the two amyloid neutralizing antibodies.
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3d rendering of bispecific antibodies
Cardiovascular

Diagonal Therapeutics’ DIAG-723 designated orphan drug for hereditary hemorrhagic telangiectasia

June 19, 2025
No Comments
Diagonal Therapeutics Inc.’s DIAG-723 has been awarded orphan drug designation by the FDA for the treatment of hereditary hemorrhagic telangiectasia (HHT). Additionally, the EMA has provided a positive opinion for orphan drug designation, confirming that DIAG-723 meets the criteria for designation as an orphan drug in the E.U.
Read More
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