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FDA Approves the First Drug for Neurotrophic Keratitis

FDA Approves the First Drug for Neurotrophic Keratitis

CP Wire

neurotrophic keratitis

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Allergan may not lose much from latest FDA rejection

Allergan may not lose much from latest FDA rejection

Biopharma Dive

uterine fibroids

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FDA Report on Enrollment Criteria for Drug Clinical Trials Points to Barriers, Strategies

FDA Report on Enrollment Criteria for Drug Clinical Trials Points to Barriers, Strategies

RAPS.org

clinical trials

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FDA extends EpiPen expiration date to ease shortages

FDA extends EpiPen expiration date to ease shortages

Biopharma Dive

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Allergan Uterine Fibroids Therapy Hits Regulatory Setback

Allergan Uterine Fibroids Therapy Hits Regulatory Setback

BioCentury

ulipristal acetate

uterine fibroids

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Microbiome Report for Week Ending 8/18/18

Microbiome Report for Week Ending 8/18/18

CP Wire

SkinBio Therapeutics

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FDA gives Merck ‘real-time’ OK for Keytruda, offering a peek at the latest extension of the agency’s data express highway

FDA gives Merck ‘real-time’ OK for Keytruda, offering a peek at the latest extension of the agency’s data express highway

Endpoints

non-squamous non-small cell lung cancer

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Eisai-Merck partnership picks up first-line Lenvima approval

Eisai-Merck partnership picks up first-line Lenvima approval

Biopharma Dive

hepatocellular carcinoma

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Janssen, Lundbeck and Takeda Raise Issues With FDA Draft Guidance on MDD Drugs

Janssen, Lundbeck and Takeda Raise Issues With FDA Draft Guidance on MDD Drugs

RAPS.org

major depressive disorder

drug development

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FDA clears first dual-lead nerve stimulator for pain relief

FDA clears first dual-lead nerve stimulator for pain relief

Fierce Biotech

SPR Therapeutics

dual-lead peripheral nerve stimulation

post-operative pain

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FDA Accepts Priority Review of ALXN1210 as a Treatment for Patients with Paroxysmal Nocturnal Hemoglobinuria

FDA Accepts Priority Review of ALXN1210 as a Treatment for Patients with Paroxysmal Nocturnal Hemoglobinuria

CP Wire

Alexion Pharmaceuticals

paroxysmal nocturnal hemoglobinuria

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Pfizer responds to FDA, EMA and Canada after reinspections of plant that makes injected painkillers

Pfizer responds to FDA, EMA and Canada after reinspections of plant that makes injected painkillers

Fierce Pharma

drug manufacturing

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Microbiome-Based Products: FDA Delves Into the Unregulated

Microbiome-Based Products: FDA Delves Into the Unregulated

RAPS.org

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2 Reasons Alnylam Stock Fell on a Landmark Drug Approval

2 Reasons Alnylam Stock Fell on a Landmark Drug Approval

Motley Fool

hATTR amyloidosis

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Bristol Nabs Immunotherapy’s First FDA Nod for Small Cell Lung Cancer

Bristol Nabs Immunotherapy’s First FDA Nod for Small Cell Lung Cancer

Xconomy

Bristol-Myers Squibb

small cell lung cancer

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Just a few days after a stumble, FDA OKs 12-week dose for Eylea as Regeneron braces for Novartis attack

Just a few days after a stumble, FDA OKs 12-week dose for Eylea as Regeneron braces for Novartis attack

Endpoints

wet age-related macular degeneration

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Is FDA doing enough to support medical device security?

Is FDA doing enough to support medical device security?

Healthcare IT News

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Sun Pharma receives USFDA nod for ophthalmic solution used to treat dry eye disease

Sun Pharma receives USFDA nod for ophthalmic solution used to treat dry eye disease

Economic Times, India

dry eye disease

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Vertex cystic fibrosis drug gets expanded approval for use in infants

Vertex cystic fibrosis drug gets expanded approval for use in infants

Reuters

Vertex Pharmaceuticals

cystic fibrosis

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US agency to rule on Tecentriq’s most important use

US agency to rule on Tecentriq’s most important use

EP Vantage

non-squamous non-small cell lung cancer

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