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FDA Approval 'Finally' Recognizes Vertebral Body Tethering as a Mainstream Scoliosis Treatment

FDA Approval 'Finally' Recognizes Vertebral Body Tethering as a Mainstream Scoliosis Treatment

Medical Devices and Diagnostics Industry

vertebral body tethering

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Rinvoq approval bolsters AbbVie's autoimmune portfolio

Rinvoq approval bolsters AbbVie's autoimmune portfolio

BioCentury

rheumatoid arthritis

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Generic Drug Approvals Hit Another Record High as Competition, Quality Questions Linger

Generic Drug Approvals Hit Another Record High as Competition, Quality Questions Linger

RAPS.org

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Celgene wins approval for drug key to Bristol buyout

Celgene wins approval for drug key to Bristol buyout

Biopharma Dive

Bristol-Myers Squibb

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FDA approves TAVR valves for low-risk patients

FDA approves TAVR valves for low-risk patients

Mass Device

Heart Valve Replacement

Edward Lifesciences

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EMA and FDA Historically Agree on Just About Every New Drug Approval, but is That Slowly Changing?

EMA and FDA Historically Agree on Just About Every New Drug Approval, but is That Slowly Changing?

RAPS.org

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Gene therapies to test FDA's approach to regulating drugs after launch, experts say

Gene therapies to test FDA's approach to regulating drugs after launch, experts say

Bizjournals

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Four New Drugs are Around the Corner. Here’s What You Need to Know.

Four New Drugs are Around the Corner. Here’s What You Need to Know.

Xconomy

Sarepta Therapeutics

Nabriva Therapeutics

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Y-mAbs ramps up head count in post-IPO hiring spree

Y-mAbs ramps up head count in post-IPO hiring spree

Fierce Biotech

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Roche scores double cancer approval for new Bayer rival Rozlytrek

Roche scores double cancer approval for new Bayer rival Rozlytrek

Fierce Pharma

NTRK fusion-positive tumors

non-small cell lung cancer

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The real-world evidence project at the FDA adds Syapse to its list of partners in a push past trial boundaries

The real-world evidence project at the FDA adds Syapse to its list of partners in a push past trial boundaries

Endpoints

clinical trials

real world evidence

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Dr. Reddy's Copaxone, NuvaRing generics derailed by FDA

Dr. Reddy's Copaxone, NuvaRing generics derailed by FDA

Fierce Pharma

Teva Pharmaceutical

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FDA approves TB pill that cures more hard-to-treat patients

FDA approves TB pill that cures more hard-to-treat patients

Stat

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AveXis scientific founder is out as Novartis names a new CSO in wake of an ethics scandal

AveXis scientific founder is out as Novartis names a new CSO in wake of an ethics scandal

Endpoints

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Novartis inspection puts into question who knew what—and when—about Zolgensma data manipulation

Novartis inspection puts into question who knew what—and when—about Zolgensma data manipulation

Fierce Pharma

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10 Events in Medtech That We Didn’t See Coming This Year

10 Events in Medtech That We Didn’t See Coming This Year

Medical Devices and Diagnostics Industry

Edwards Lifesciences

Boston Scientific

Thrive Earlier Detection

robotic surgery

Becton Dickinson

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FDA to Drug Manufacturers: Outdated Listings Will be Inactivated

FDA to Drug Manufacturers: Outdated Listings Will be Inactivated

RAPS.org

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5 Biggest New Drugs Approved in 2019 So Far

5 Biggest New Drugs Approved in 2019 So Far

Motley Fool

multiple sclerosis

metastatic bladder cancer

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Questions pile up for Novartis as senators call on FDA to take action

Questions pile up for Novartis as senators call on FDA to take action

Endpoints

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Regeneron gets FDA approval for Eylea injection prefilled syringe

Regeneron gets FDA approval for Eylea injection prefilled syringe

Ophthalmology Times

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