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Orthopedic Device Coatings Guidance

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FDA publishes a draft guidance on characterizing metallic or calcium phosphate coatings on Class 2 and 3 orthopedic medical device...

OPDP Letter Cites Novartis on Kisqali Ad

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CDERs Office of Prescription Drug Promotion (OPDP) faults a Novartis direct-to-consumer TV ad promoting it breast cancer therapy K...

Ionis Plans NDA for Donidalorsen

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Ionis Pharmaceuticals plans an NDA submission based on data from the Phase 3 OASIS-HAE study in people with hereditary angioedema.

Pharvaris Clinical Hold Lifted

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FDA lifts a clinical hold against a Pharvaris IND for deucrictibant, an investigational therapy for the prophylactic treatment of ...

Draft Guide on Orthopedic Device Coatings

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FDA posts a draft guidance entitled Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices....

Priority Review for Xolair Food Allergy sBLA

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FDA accepts for priority review a Genentech supplemental BLA for Xolair (omalizumab) for reducing allergic reactions, including an...

De Novo OK for Osteopenia Device

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FDA grants Bone Health Technologies a de novo marketing authorization for its Osteoboost, the first non-pharmacological device-bas...

Gilead Trodelvy Trial Misses Endpoint

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Gilead Sciences says its Trodelvy Phase 3 EVOKE-01 study did not meet its primary endpoint of overall survival in previously treat...

Kallisio Oral Stent Cleared

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FDA clears a Kallisio 510(k) for Stentra, a 3D-printed oral stent designed to protect healthy tissue in head and neck cancer patie...

Info Collection on Rx Drug Marketing

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Federal Register notice: FDA seeks comments on an information collection extension entitled Prescription Drug Marketing: Administr...