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FDA Approves Janssen’s Symtuza for HIV-1 Infection

The U.S. FDA approved Symtuza, the first complete darunavir-based single-tablet regimen for the treatment of human immunodeficiency virus type 1 in treatment-naïve and certain virologically suppressed adults.

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FDA approves the first drug with an indication for treatment of smallpox

The U.S. FDA approved TPOXX (tecovirimat), the first drug with an indication for the treatment of smallpox.

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U.S. FDA Approves Xtandi for Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer

Astellas Pharma Inc. and Pfizer Inc. announced the U.S. FDA approved a supplemental New Drug Application for Xtandi (enzalutamide), following FDA Priority Review designation.

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Bausch + Lomb Announces FDA Filing Acceptance

Bausch + Lomb announced the U.S. FDA accepted the New Drug Application for the company’s sub-micron loteprednol etabonate ophthalmic gel 0.38% with a PDUFA date of Feb. 25, 2019.

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Merz Snags FDA Approval for Chronic Sialorrhea

The FDA approved Merz Neurosciences’ supplemental Biologics License Application for Xeomin (incobotulinumtoxinA), a treatment for chronic drooling in adults with neurodegenerative diseases.

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AstraZeneca wins speedy approvals for cancer drugs in Japan

AstraZeneca won rapid regulatory approval for new uses of two of the company’s important cancer drugs in Japan.

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Dermira wipe approved for excessive armpit sweating

The U.S. Food and Drug Administration approved Dermira Inc.’s topical cloth for excessive armpit sweating, providing patients with an easy-to-use option for an often embarrassing condition.

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Array BioPharma gets FDA nod for melanoma combo treatment

The U.S. Food and Drug Administration approved Array BioPharma Inc.’s oral combination treatment for use in patients with the deadliest form of skin cancer.

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FDA Approves World’s First Long-Term Implantable Continuous Glucose Monitoring System

The U.S. FDA approved Senseonics Holdings’ Premarket Approval application to market the company’s Eversense Continuous Glucose Monitoring System to people with diabetes.

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FDA clears Pfizer’s Xeljanz for inflammatory bowel disease

The U.S. FDA approved Pfizer’s blockbuster drug Xeljanz to treat adults with moderate-to-severe active ulcerative colitis.

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TherapeuticsMD’s therapy for menopause-related condition gets approval

TherapeuticsMD Inc. won its first-ever FDA approval as the U.S. drug regulator cleared the women’s healthcare company’s hormone therapy – after rejecting it one year earlier – for a painful condition triggered by menopause.

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FDA Clears Sun Pharma’s Yonsa for Prostate Cancer

Sun Pharmaceutical Industries received approval from the U.S. Food and Drug Administration for Yonsa (abiraterone acetate) to treat metastatic castration-resistant prostate cancer.

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AstraZeneca wins U.S. approval for 1st-line use of lung cancer drug

U.S. regulators expanded use of AstraZeneca’s lung cancer drug Tagrisso to include initial treatment of patients with a specific genetic mutation.

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Eisai Submits Fycompa Pediatric Indications to FDA

Eisai Inc. submitted a supplemental New Drug Application for priority review to the U.S. FDA for the company’s antiepileptic drug Fycompa (perampanel) CIII as monotherapy and adjunctive use.

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FDA approves Toujeo Max SoloStar

The U.S. Food and Drug Administration approved Sanofi’s Toujeo (insulin glargine 300 Units/mL) Max SoloStar, the highest capacity long-acting insulin pen that will be available on the market.

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FDA Approves Multi-Drug Resistant HIV-1 Treatment

Shares of Theratechnologies and TaiMed Biologics jumped after the U.S. Food and Drug Administration green lit Trogarzo (ibalizumab), the first HIV-1 inhibitor for patients with multi-drug resistant HIV-1.

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FDA Grants Sunovion’s Latuda Expanded Approval

The FDA approved a supplemental NDA that expands the use of Sunovion’s Latuda to include treating major depressive episode associated with bipolar I disorder in pediatric patients.

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U.S. FDA approves Gilead triple HIV drug

The FDA approved Biktarvy, Gilead’s once-daily, triple-combo tablet for treating HIV infection, paving the way for the biotech company to capture more of the multibillion-dollar HIV drug market.

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Ferring’s Zomacton Receives FDA Approval to Treat Growth Hormone Deficiency in Adults

Ferring Pharmaceuticals Inc. announced that the U.S. FDA approved Zomacton (somatropin) for Injection 5 mg and 10 mg recombinant human growth hormone (GH) indicated for replacement of GH in adults with GH deficiency.

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FDA Approves Trulance for IBS-C in Adults

Synergy Pharmaceuticals Inc. announced that the U.S. FDA approved Trulance (plecanatide) 3-mg tablet for the once-daily treatment of irritable bowel syndrome with constipation in adults.

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