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11 Dr. Reddys ANDAs Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws 11 ANDAs from Dr. Reddys Laboratories after the company requested the actions because the p...

HistoSonics De Novo for Tumor Blaster

[ Price : $8.95]

FDA grants HistoSonics a de novo marketing authorization for the Edison System, which the company says uses focused sound energy t...

AstraZeneca Seeks More Input on Study Diversity

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AstraZeneca urges FDA to provide more detailed guidance or recommendations on how early in the drug development process sponsors s...

Sun Pharma NDA for Alopecia Areata

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FDA accepts for review a Sun Pharmaceutical Industries NDA for deuruxolitinib, an investigational oral selective inhibitor of Janu...

2 Covid-19 Product EUAs Revoked

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Federal Register notice: FDA announces the revocation of two Monkeypox-related Emergency Use Authorizations after the authorizatio...

Notice on Info Technology Plan Corrected

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Federal Register notice: FDA corrects a 9/19 notice entitled Food and Drug Administration Information Technology Strategy; Request...

Novartis Gains Approval of IV Cosentyx

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FDA approves Novartis intravenous Cosentyx (secukinumab) formulation for treating adults with psoriatic arthritis, ankylosing spon...

Senator Urges Justice Probe of Respironics

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Sen. Richard Blumenthal (D-CT) calls on the Justice Department to take action against Philips Respironics after a recent investiga...

FDA OKs Zoryve Cream Expanded Use

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FDA approves an Arcutis Biotherapeutics supplemental NDA to expand the indication for Zoryve (roflumilast) cream 0.3% for the topi...

Syndax Reports Positive Leukemia Data

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Syndax Pharmaceuticals says new positive data justifies stopping the pivotal AUGMENT-101 trial of revumenib in adult and pediatric...