Ask what regulators accepted. Get the page it's written on.
Including the 770 times FDA and EMA accepted a package that didn't follow the guideline to the letter, and why.
FreeCited to FDA & EMA reviewsUpdated 13 Oct 2026Next update 7 Dec 2026
Every claim comes with the regulator's own sentence
- Ask in plain languageYour modality, target and question. No query syntax.
- See the evidenceThe closest sentences from FDA and EMA reviews, each with its page. Gaps are shown as gaps.
- Open the sourceOne click to the document and page, ready to cite in your IND package.
Which species did FDA accept for CD3 bispecifics, and why?
- ElrexfioBCMA x CD3 · SpeciesCynomolgus monkey only“Cynomolgus monkey was identified as the only relevant nonclinical toxicology species based on elranatamab binding affinities for BCMA and CD3.”
- TecvayliBCMA x CD3 · Why that speciesBinds monkey CD3 and BCMA (BCMA ~36-fold lower affinity); no rodent CD3 binding, rabbit not expected to bind“The parental CD3 monoclonal antibody did not bind rodent CD3, and teclistamab is not expected to bind rabbit CD3 or BCMA due to low sequence similarity; thus, the cynomolgus monkey was determined to be a pharmacologically relevant species for toxicology studies.”
- ImdelltraDLL3 x CD3 · SpeciesCynomolgus monkey (pivotal); mouse surrogate muS757 for EFD and 1-month study“The cynomolgus monkey was selected for toxicology testing given that tarlatamab similarly bound human and monkey CD3 and DLL3 but did not bind CD3 from other species.”
The guideline is the letter. Regulators judge the spirit.
In 770 cases, FDA and EMA accepted a nonclinical package that didn't follow the guideline to the letter. See what they accepted, the justification, and the reviewer's own words.
See it for: Antibodies · Multispecifics · ADCs · Oligos · Gene therapy · Cell therapy · Small molecules · Vaccines
Browse every approval, board by board
Species, study length, skipped studies, first dose and risks for every approved product in eight modalities. Click any cell to read the regulator's sentence.
Monoclonal antibodies
Multispecific antibodies
Antibody-drug conjugates
Oligonucleotides
Gene therapy
Cell therapy
Small molecules
Protein and VLP vaccines
We check FDA, EMA and ICH for new approvals, review documents and guidance every week, and publish an update on the first Monday of each month.
Before you file your IND
Not predictions. Precedent.
Precedia reads the FDA multi-discipline reviews, EMA assessment reports and CBER review memos themselves. A general chatbot paraphrases whatever it absorbed in training.
Every quote is checked word for word against the page it cites. A build that fails the check never ships.
“3 of 18 multispecifics disclosed their first-dose method” only means something if you have all 18. Precedia covers every approval in each of its modalities.
When a review is silent, Precedia shows the gap. It never fills it with a plausible-sounding guess.
Things the reviews reveal
public reviews say how the first human dose was set. The rest left it in the confidential IND.
approved monoclonal antibodies ran pivotal tox in: monkey only.
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Ask the question you'd normally send a consultant. Get a cited answer drawn only from FDA and EMA reviews.
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