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Lilly Expands Breast Cancer Choices & Novo Signs for Three Obesity Programs
Lilly Expands Breast Cancer Choices & Novo Signs for Three Obesity Programs

Season 1

FDA fully approved Lilly's Inluriyo (imlunestrant) plus Verzenio (abemaciclib) after progression in ESR1-mutated advanced breast cancer; evidence is …

15 hours ago

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Ultragenyx Wins Sanfilippo Type A Approval & Xenon Pauses New Psychiatry Enrollment
Ultragenyx Wins Sanfilippo Type A Approval & Xenon Pauses New Psychiatry Enrollment

Season 1

Ultragenyx's Fayuvi approval opens a first treatment path for eligible children with Sanfilippo syndrome type A, with preserved function and center a…

1 day, 1 hour ago

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Skyhawk's Early Huntington Signal Faces a Bigger Test & Sling Raises $123M
Skyhawk's Early Huntington Signal Faces a Bigger Test & Sling Raises $123M

Season 1

Skyhawk's early SKY-0515 Huntington's signal faces randomized confirmation, while Sling's $123M financing advances oral linsitinib for thyroid eye di…

2 days, 5 hours ago

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Vera’s Kidney Data Strengthen Full-Approval Case & Curium Challenges Novartis’ Lutathera
Vera’s Kidney Data Strengthen Full-Approval Case & Curium Challenges Novartis’ Lutathera

Season 1 Episode 172

Vera reports a 76% reduction in composite kidney-disease progression risk and near-stable two-year kidney function for TRUTAKNA (atacicept-vymj) in s…

3 days, 12 hours ago

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Daily Roundup | Enhertu Delays Lung Cancer Progression, Survival Benefit Unproven
Daily Roundup | Enhertu Delays Lung Cancer Progression, Survival Benefit Unproven

Season 1

Enhertu delayed lung cancer progression in a Phase 3 trial, but immature survival results and fatal lung toxicity complicate the first-line case. Def…

4 days, 8 hours ago

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Week in Review | AstraZeneca’s Setback, Novartis Under Pressure & Scholar Rock’s Approval
Week in Review | AstraZeneca’s Setback, Novartis Under Pressure & Scholar Rock’s Approval

AstraZeneca's broader-use trial of Etcamah (camizestrant)missed its primary goal in advanced breast cancer, while the existing approval stands. Schol…

5 days, 14 hours ago

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Exelixis Faces FDA Delay & Karyopharm Faces October Deadline
Exelixis Faces FDA Delay & Karyopharm Faces October Deadline

Season 1 Episode 171

FDA extended its review of Exelixis's zanzalintinib-Tecentriq combination for metastatic colorectal cancer to March 3, 2027, after classifying update…

1 week ago

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Biohaven Faces FDA Enrollment Hold & AbbVie Reports Menstrual Migraine Results
Biohaven Faces FDA Enrollment Hold & AbbVie Reports Menstrual Migraine Results

Season 1 Episode 170

Biohaven's FDA partial hold pauses new epilepsy-trialenrollment; the company still expects RISE-3 results this year. AbbVie reports LUNA menstrual-mi…

1 week, 1 day ago

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Bayer's Hyrnuo Enters First-Line Rivalry & FDA Gets Permanent Center Chiefs
Bayer's Hyrnuo Enters First-Line Rivalry & FDA Gets Permanent Center Chiefs

Season 1 Episode 169

Bayer's Hyrnuo (sevabertinib) gains first-line accelerated approval in HER2-mutant lung cancer, joining an established rival. Permanent FDA center le…

1 week, 2 days ago

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Novartis's HARBOR Miss Tests Confidence in the Growth Plan & Rasonque's Access Hurdles
Novartis's HARBOR Miss Tests Confidence in the Growth Plan & Rasonque's Access Hurdles

Season 1 Episode 168

Novartis's del-desiran missed HARBOR's primary endpoint in myotonic dystrophy, adding pressure to a growth plan already facing setbacks. Roivant and …

1 week, 3 days ago

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