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20 Drugs Not Withdrawn Over Safety/Efficacy

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Federal Register notice: FDA determines that 20 listed drug products were not withdrawn from sale due to safety or effectiveness i...

Hold on Tryp Therapeutics Eating Disorder Study

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FDA issues a clinical hold against Tryp Therapeutics and a Phase 2a study evaluating its psilocybin for eating disorders.

PD-1 Inhibitor BLA Yanked After Keytruda Approval

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Agenus withdraws a BLA for balstilimab after FDA urged it to do so following Mercks recent full approval for pembrolizumab for tre...

FDA Approves Large Photodynamic Therapy Light

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FDA approves Biofronteras BF-RhodoLED XL, a red-light source for photodynamic therapy and its combination use with the companys Am...

Susvimo Eye Implant for Wet AMD Approved

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FDA approves Genentechs Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for treating certain peo...

FDA Withdraws Approval for 216 ANDAs

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Federal Register notice: FDA withdraws the approval of 216 ANDAs from multiple holders because they repeatedly failed to submit re...

Biden Meets with Potential FDA Head Califf

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President Biden meets with potential FDA commissioner nominee Robert Califf in what may be the last step before an official announ...

Regulatory Review Determined for Orions Nubeqa

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Orion Corp.s Nubeqa (darolu...

Comments Sought on Xenotransplantation Guideline

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Federal Register notice: FDA seeks comments on an information collection extension entitled PHS Guideline on Infectious Disease Is...

FDA Denies Vaccine EUA Revocation Petition

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FDA denies an Informed Consent Action Network petition asking it to revoke the EUAs for the Moderna and J&J Covid vaccines.