FDA approves leucovorin for cerebral folate deficiency

Vinay Prasad, oncology’s gadfly-turned-CBER-director, will leave FDA (again)

Amid deepening controversy, Vinay Prasad, FDA’s top clinician and scientist, and director of its Center for Biologics Evaluation and Research, will be leaving the agency.

March 13, 2026

Vol.52 No.10

By Claire Marie Porter

Regulatory News

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology
Atara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

On Jan. 9, Pierre Fabre Pharmaceuticals received a “complete response letter” from FDA: its application for the T-cell therapy tabelecleucel (Ebvallo) was getting a hard No.

FDA approves teclistamab + daratumumab hyaluronidase-fihj for r/r MM

FDA has approved teclistamab (Tecvayli) in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.

March 06, 2026

Vol.52 No.09

Drugs & Targets

FDA grants tentative approval for Lutetium Lu 177 dotatate

FDA has granted tentative approval for the Abbreviated New Drug Application for Lutetium Lu 177 Dotatate (PNT2003), a radioequivalent version of Lutathera (lutetium Lu 177 dotatate), which is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors.

March 06, 2026

Vol.52 No.09

Cancer Policy

FDA issues draft guidance on accelerating development of individualized therapies for ultra-rare diseases

FDA issued draft guidance for sponsors seeking full approval for targeted individualized therapies by generating substantial evidence of effectiveness and safety when randomized controlled trials are not feasible due to small patient populations.

February 27, 2026

Vol.52 No.08

Drugs & Targets

FDA approves Braftovi combination regimen in first-line metastatic colorectal cancer

FDA granted full approval to Braftovi (encorafenib) in combination with cetuximab (Erbitux) and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation based on results from the global phase III BREAKWATER trial.

February 27, 2026

Vol.52 No.08

FDA approves leucovorin for cerebral folate deficiency

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Vinay Prasad, oncology’s gadfly-turned-CBER-director, will leave FDA (again)

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology
Atara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

FDA approves teclistamab + daratumumab hyaluronidase-fihj for r/r MM

FDA grants tentative approval for Lutetium Lu 177 dotatate

FDA issues draft guidance on accelerating development of individualized therapies for ultra-rare diseases

FDA approves Braftovi combination regimen in first-line metastatic colorectal cancer

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FDA approves leucovorin for cerebral folate deficiency

YOU MAY BE INTERESTED IN

Vinay Prasad, oncology’s gadfly-turned-CBER-director, will leave FDA (again)

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncologyAtara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

FDA approves teclistamab + daratumumab hyaluronidase-fihj for r/r MM

FDA grants tentative approval for Lutetium Lu 177 dotatate

FDA issues draft guidance on accelerating development of individualized therapies for ultra-rare diseases

FDA approves Braftovi combination regimen in first-line metastatic colorectal cancer

Never miss an issue!

Login

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology
Atara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”