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Regulatory Intelligence & Drug Approvals4 days agoFDA Grants Accelerated Approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for Recurrent Respiratory Papillomatosis
PLYMOUTH MEETING, Pa., Oct. 30, 2026 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect...
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Regulatory Intelligence & Drug Approvals4 days agoPostmarketing Requirements and Commitments: Searchable Database
Learn more about FDA's Postmarketing Requirements and Commitments Searchable Database.
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Regulatory Intelligence & Drug Approvals4 days agoFDA Rationale for Breakpoints Recognition Decision: Minocycline for Stenotrophomonas maltophilia
FDA Rationale for Breakpoints Recognition Decision: Minocycline for Stenotrophomonas maltophilia
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Regulatory Intelligence & Drug Approvals4 days agoPlatelet Factor 4 (PF4) Radioimmunoassay Recall: Instrumentation Laboratories Removes HemosIL AcuStar HIT-IgG(PF4-H)
Product performance issue may lead to a false negative result which will delay recognition of heparin-induced thrombocytopenia.
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Regulatory Intelligence & Drug Approvals5 days ago
HUTCHMED Announces Sovleplenib Granted US FDA Orphan Drug Designation for Primary Immune Thrombocytopenia
Hong Kong, Shanghai & Florham Park, NJ — Thursday, October 29, 2026: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the US Food and Drug...
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Regulatory Intelligence & Drug Approvals5 days agoGDUFA III Changes for Facilities
FDA has completed several commitments under the terms of the Generic Drug User Fee Amendments of 2017 (GDUFA II) commitment letter to provide greater transparency regarding prioritization...
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Regulatory Intelligence & Drug Approvals5 days agoBIO supports FDA’s new Fit-for-Purpose Rare Disease Framework Initiative
BIO praised a Food and Drug Administration (FDA) initiative targeting more tailored, patient-centered, and predictable development of rare disease drugs, while recommending ways to […] The...
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Regulatory Intelligence & Drug Approvals5 days agoHHS to allow compounders to make 6 unapproved peptides
RFK Jr. has given notice that the agency won’t take enforcement action on six peptides that controversially won a contested recommendation from outside advisers to the...
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Regulatory Intelligence & Drug Approvals5 days agoSTAT+: El-Sayed claps back at RFK Jr., and FDA’s ‘enforcement discretion’ on peptides
Abdul El-Sayed, the Democratic Senate candidate in Michigan, pushes back against the RFK Jr.'s claims, and the new FDA policy around peptides.
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Regulatory Intelligence & Drug Approvals5 days agoSTAT+: HHS green lights six peptides, despite concerns from FDA scientists
Great news for peptide fans: The Trump administration is giving the peptide craze a regulatory boost, despite objections from FDA career scientists.
RNA-protein interactions could lead to new coronavirus drug targets
A CRISPR gene boost reduces seizures and strengthens muscles in mice
Automated platform optimizes enzyme production using cell-free protein synthesis and AI-driven design
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
