FDA launches consolidated adverse event reporting system

CBER Director Vinay Prasad dared to “say no to drugs”

FDA’s Center for Biologics Evaluation and Research Director Vinay Prasad is set to leave the agency for a second time amid controversy.

March 18, 2026

Regulatory News

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 leucovorin for cerebral folate deficiency

FDA has approved leucovorin calcium tablets (Wellcovorin), expanding its use for the treatment of cerebral folate deficiency in adult and pediatric patients.

March 13, 2026

Vol.52 No.10

By Claire Marie Porter

Drugs & Targets

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

FDA launches consolidated adverse event reporting system

YOU MAY BE INTERESTED IN

CBER Director Vinay Prasad dared to “say no to drugs”

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 leucovorin for cerebral folate deficiency

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

FDA grants tentative approval for Lutetium Lu 177 dotatate

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FDA launches consolidated adverse event reporting system

YOU MAY BE INTERESTED IN

CBER Director Vinay Prasad dared to “say no to drugs”

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 leucovorin for cerebral folate deficiency

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

FDA grants tentative approval for Lutetium Lu 177 dotatate

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.”