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FDA Finds MED-EL Cochlear Implant ‘Sound’ For Unilateral Hearing Loss

FDA Finds MED-EL Cochlear Implant ‘Sound’ For Unilateral Hearing Loss

Xtalks

Cochlear Implant

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Lawmakers press Sharpless to bring stem cell companies into line

Lawmakers press Sharpless to bring stem cell companies into line

BioCentury

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Nektar takes a hit as the FDA swerves away from opioid reviews — leaving NKTR-181 in limbo

Nektar takes a hit as the FDA swerves away from opioid reviews — leaving NKTR-181 in limbo

Endpoints

Nektar Therapeutics

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Following EMA, FDA restricts use of high-dose Xeljanz, warning of added risks for the blockbuster JAK

Following EMA, FDA restricts use of high-dose Xeljanz, warning of added risks for the blockbuster JAK

Endpoints

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Go or no go? Abbvie, Roche and Kala await key decisions

Go or no go? Abbvie, Roche and Kala await key decisions

EP Vantage

Kala Pharmaceuticals

dry eye disease

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Epizyme announces FDA filing acceptance of new drug application and priority review for tazemetostat to treat epithelioid sarcoma

Epizyme announces FDA filing acceptance of new drug application and priority review for tazemetostat to treat epithelioid sarcoma

Pharmaceutical Business Review

epithelioid sarcoma

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In a first, Lilly's ready-to-use rescue hypoglycemia powder wins US approval

In a first, Lilly's ready-to-use rescue hypoglycemia powder wins US approval

Endpoints

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FDA to reconsider Braeburn’s opioid addiction drug after court ruling

FDA to reconsider Braeburn’s opioid addiction drug after court ruling

Pharmaforum

opioid addiction

Braeburn Pharmaceuticals

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Allergan Pulls Textured Breast Implant Following FDA Request

Allergan Pulls Textured Breast Implant Following FDA Request

RAPS.org

product recalls

breast implants

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Elizabeth Warren presses Pfizer to fork over information on Scott Gottlieb

Elizabeth Warren presses Pfizer to fork over information on Scott Gottlieb

Stat

Elizabeth Warren

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FDA-approved Humira copycat from Merck, Samsung Bioepis will wait 4 years to launch

FDA-approved Humira copycat from Merck, Samsung Bioepis will wait 4 years to launch

Endpoints

Samsung Bioepis

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Vertex files cystic fibrosis triple therapy with FDA

Vertex files cystic fibrosis triple therapy with FDA

PM Live

Vertex Pharmaceuticals

cystic fibrosis

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FDA cancels panel review of Intra-Cellular’s schizophrenia drug, causing shares to tumble

FDA cancels panel review of Intra-Cellular’s schizophrenia drug, causing shares to tumble

Stat

Intra-Cellular Therapies

advisory panels

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FDA approves Rituxan biosimilar

FDA approves Rituxan biosimilar

Beckers Hospital Review

autoimmune disease

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Merck's biosimilar to AbbVie's Humira wins FDA approval

Merck's biosimilar to AbbVie's Humira wins FDA approval

Reuters

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ViiV’s first-in-class HIV drug on course for filings this year

ViiV’s first-in-class HIV drug on course for filings this year

Pharmaforum

ViiV Healthcare

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Lyrica generics roll: Pfizer blockbuster finally hits patent cliff

Lyrica generics roll: Pfizer blockbuster finally hits patent cliff

Fierce Pharma

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FDA Approves First Treatment for Oral Ulcers Associated with Rare Inflammatory Disease

FDA Approves First Treatment for Oral Ulcers Associated with Rare Inflammatory Disease

BioSpace

Behcet's disease

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In another disappointment for investors, FDA slaps down Biohaven’s revised version of an old ALS drug

In another disappointment for investors, FDA slaps down Biohaven’s revised version of an old ALS drug

Endpoints

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Acasti sits pretty as raise brings $400M for Amarin

Acasti sits pretty as raise brings $400M for Amarin

BioWorld

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