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Complement Therapeutics Gene Therapy Cleared for Trial

[ Price : $8.95]

Complement Therapeutics gains IND clearance to begin human testing of its lead gene therapy, CTx001, in patients with geographic a...

Vivaces Hippo Pathway Drug VT3989 Gets Fast Track

[ Price : $8.95]

FDA grants Vivace Therapeutics a fast track designation for its lead cancer drug VT3989, a first-in-class TEAD autopalmitoylation ...

3 CGMP Violations at Naturich Cosmetique

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FDA warns Garland, TX-based Naturich Cosmetique about CGMP violations in its production of finished drugs.

Trividia Recalls 1 Lot of Glucose Meters

[ Price : $8.95]

FDA says Trividia Health has recalled 601 blood glucose meters that may have defective LCD displays.

FDA Rejects Xspray Pharmas Leukemia Drug NDA

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FDA issues Xspray Pharma a complete response letter on its NDA for Dasynoc (dasatinib) and its use for treating chronic myeloid le...

Lilly Partial Win Over FDAs Biologic Classification

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A federal judge gives Eli Lilly a partial win in a lawsuit challenging FDAs refusal to classify retatrutide the companys investig...

AstraZeneca Reports Favorable Hypertension Drug Data

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AstraZeneca says its investigational drug baxdrostat met the primary endpoint in the Phase 3 Bax24 trial in patients with resistan...

Fire CDER, OGD Directors: Members of Congress

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Thirteen Republican House members call on HHS to lay off the CDER director, Office of Generic Drugs director, and others who were ...

FDA Clears Trial Restart of Recurring Stroke Device

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FDA clears restart of a pivotal clinical trial evaluating the NobleStitch EL system, a device-free, suture-mediated method for clo...

Boehringers Jascayd OKd for Pulmonary Fibrosis

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FDA approves a Boehringer Ingelheim NDA for Jascayd (nerandomilast) tablets for treating idiopathic pulmonary fibrosis.