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FDA Overlooked Red Flags In Drugmaker’s Testing of New Depression Medicine

FDA Overlooked Red Flags In Drugmaker’s Testing of New Depression Medicine

KHN

major depressive disorder

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Roche touts phase 2 Gazyva data in lupus patients with a potentially fatal kidney complication

Roche touts phase 2 Gazyva data in lupus patients with a potentially fatal kidney complication

Fierce Pharma

lupus nephritis

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Novo Nordisk goes for broke on semaglutide heart data

Novo Nordisk goes for broke on semaglutide heart data

Biopharma Dive

oral semaglutide

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Merck's Keytruda wins FDA approval to treat head and neck cancer

Merck's Keytruda wins FDA approval to treat head and neck cancer

Yahoo/Reuters

head and neck cancer

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NASH drugmaker stocks rebound after dip on FDA guidance

NASH drugmaker stocks rebound after dip on FDA guidance

Biopharma Dive

Madrigal Pharmaceuticals

Viking Therapeutics

Intercept Pharma

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Roche snags first-in-class FDA nod for lymphoma drug Polivy

Roche snags first-in-class FDA nod for lymphoma drug Polivy

Fierce Pharma

diffuse large B-cell lymphoma

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BIO Roundup: Agenus, FDA, Merck’s Frazier and Much More

BIO Roundup: Agenus, FDA, Merck’s Frazier and Much More

BioSpace

immuno-oncology

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The gene therapy era has arrived. So have the challenges.

The gene therapy era has arrived. So have the challenges.

Biopharma Dive

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FDA to Explore Randomized Trials Using RWE for Regulatory Purposes

FDA to Explore Randomized Trials Using RWE for Regulatory Purposes

RAPS.org

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FDA's Draft Guidance Proposes Ways to Increase Patient Diversity in Clinical Trials

FDA's Draft Guidance Proposes Ways to Increase Patient Diversity in Clinical Trials

BioSpace

clinical trials

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GlaxoSmithKline's Nucala scores convenience boost with at-home dosing options

GlaxoSmithKline's Nucala scores convenience boost with at-home dosing options

Fierce Pharma

eosinophilic asthma

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Reata Pharmaceuticals gets orphan drug designation for bardoxolone methyl to treat ADPKD

Reata Pharmaceuticals gets orphan drug designation for bardoxolone methyl to treat ADPKD

Pharmaceutical Business Review

Reata Pharmaceuticals

autosomal dominant polycystic kidney disease

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Celgene can breathe a sigh of relief as FDA accepts once-spurned ozanimod application — setting a target date on a blockbuster decision

Celgene can breathe a sigh of relief as FDA accepts once-spurned ozanimod application — setting a target date on a blockbuster decision

Endpoints

multiple sclerosis

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The FDA is forcing a small antibiotic player back to the clinic for a new trial — 10 years after first rejection

The FDA is forcing a small antibiotic player back to the clinic for a new trial — 10 years after first rejection

Endpoints

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Cheaper Versions of the Most Expensive Drugs May be Coming, but Monopolies Will Likely Remain

Cheaper Versions of the Most Expensive Drugs May be Coming, but Monopolies Will Likely Remain

Motley Fool

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ASCO Soundbites, vol. 3: Real-time approvals, Pfizer's second rodeo and 'the busiest ASCO ever'

ASCO Soundbites, vol. 3: Real-time approvals, Pfizer's second rodeo and 'the busiest ASCO ever'

Fierce Pharma

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3 Drug Stocks That Could Win From Key FDA Approvals in June

3 Drug Stocks That Could Win From Key FDA Approvals in June

Motley Fool

Amag Pharmaceuticals

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Years after Cubist buyout, Merck scores a new Zerbaxa indication. Can it jump-start sales?

Years after Cubist buyout, Merck scores a new Zerbaxa indication. Can it jump-start sales?

Fierce Pharma

hospital-acquired infections

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