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Mercks Oral PCSK9 Candidate Cuts LDL by Up to 60%

[ Price : $8.95]

Merck reports positive Phase 3 results for its oral PCSK9 inhibitor enlicitide, showing LDL-cholesterol reductions approaching 60%...

Fresenius Recalls 4 Lots of Famotidine Injection

[ Price : $8.95]

Fresenius Kabi recalls three lots of its famotidine injection after reserve samples from one lot tested out of specification for e...

Experts Urge Federal Action on Supply Chain Resilience

[ Price : $8.95]

A group of leaders from government, academia, and the pharmaceutical industry call for sweeping federal action to stabilize the U....

Cogents Bezuclastinib Combo Delivers Phase 3 Win

[ Price : $8.95]

Cogent Biosciences reports positive data from a Phase 3 study of its KIT inhibitor bezuclastinib, saying that the drug combined wi...

FDA 483 Cites Quality Deficiencies at Indian Drug Plant

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FDA cites Medispray Laboratories, a finished drug product manufacturer based in Ponda, Goa, India, for significant lapses in its q...

Patient Injured in Intellias Phase 3 nex-z Trial Dies

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Intellia Therapeutics reports that a patient who experienced liver toxicity after being administered the companys CRISPR-based the...

FDA OKs Darzalex Faspro for Smoldering Multiple Myeloma

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FDA approves Janssens Darzalex Faspro (daratumumab and hyaluronidase-fihj) for adults with high-risk smoldering multiple myeloma (...

Senate Democrats Caution FDA on Mifepristone Review

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Senate Democrats say they are worried that FDA and HHS may rely on partisan junk science during its recently announced review of t...

FDA Posts Biohaven Troriluzole Complete Response Letter

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FDA publicly releases an 11/4 complete response letter issued to Biohaven on its NDA seeking approval for troriluzole to treat spi...

FDA Extends Review of Rhythms Setmelanotide sNDA

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FDA extends by three months its review of Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide) and its use in trea...