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Sun Pharma’s Xelprost Wins FDA Approval

The U.S. FDA approved the New Drug Application of Xelpros 0.005% for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

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FDA approves AstraZeneca’s drug for rare form of blood cancer

The U.S. FDA approved AstraZeneca Plc’s treatment for hairy cell leukemia, a slow-growing type of blood cancer.

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FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA), a Rare Form of Juvenile Arthritis

Roche Group member Genentech announced today that the U.S. FDA approved the subcutaneous formulation of Actemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.

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Boost for ‘made in China’ medicine as Chi-Med wins key approval

Hutchison China MediTech won Chinese approval for a closely watched new cancer drug in a significant boost for “made in China” medicine.

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Bayer’s hemophilia A treatment gets U.S. FDA approval

The U.S. FDA approved Bayer AG’s long-acting treatment for hemophilia A, a rare genetic disorder in which blood does not clot easily.

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U.S. FDA Approves Imbruvica For Rare Blood Cancer

The Janssen Pharmaceutical Companies of J&J announced the U.S. FDA approval of Imbruvica (ibrutinib) in combination with rituximab for the treatment of Waldenström’s macroglobulinemia.

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Novartis wins EU approval for blood cancer therapy Kymriah

Novartis received European approval for Kymriah, the Swiss drugmaker’s gene-modifying therapy for blood cancer.

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FDA Clears Ortho Dermatologics’ Acne Lotion Altreno

The U.S. FDA approved Ortho Dermatologics’ NDA for Altreno (tretinoin 0.05%) lotion, indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

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FDA approves Shire drug for rare swelling disorder

The U.S. FDA approved a first-of-its-kind drug from Shire Plc to treat patients aged 12 and older suffering from a rare hereditary disease that causes swelling.

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FDA Approves Expanded Label For Merck’s Keytruda

The U.S. FDA approved an expanded label for Merck’s anti-PD-1 therapy Keytruda in combination with Alimta (pemetrexed) and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations, based on results of the KEYNOTE-189 trial.

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Roche’s Alecensa latest beneficiary of faster China drug approvals

Roche’s Alecensa lung cancer medicine became the latest beneficiary of China’s efforts to speed up approvals in the world’s second-biggest drug market, which is gaining importance for global pharmaceuticals companies’ growth plans.

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Regeneron Scores New Approval for Eylea Four Days After an FDA Rejection

Days after rejecting Regeneron’s attempt to secure a supplemental approval for Eylea, the FDA approved a new dosing label for the drug in wet age-related macular degeneration (wet AMD).

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FDA approves Opdivo for small cell lung cancer

The Food and Drug Administration approved Bristol-Myers Squibb’s Opdivo for patients whose lung cancer had progressed even after undergoing chemotherapy and at least one other therapy.

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FDA grants approval to Lenvima capsules for HCC

Eisai and Merck announced that the U.S. FDA approved the kinase inhibitor Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma.

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FDA approves Teva’s generic of Mylan’s EpiPen

The U.S. Food and Drug Administration approved Teva Pharmaceutical Industries Ltd.’s generic version of Mylan NV’s life-saving allergy injection EpiPen.

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U.S. FDA Approves Sun Pharmaceuticals’ Cequa

Sun Pharmaceutical Industries Ltd. received FDA approval for Cequa (cyclosporine ophthalmic solution) 0.09% to increase tear production in patients with keratoconjunctivitis sicca.

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FDA Clears SPR Therapeutics’ Non-opioid SPRINT endura and extensa Peripheral Nerve Stimulation Systems for Pain Management

SPR Therapeutics Inc., a leader in neurostimulation technology for pain, announced that the U.S. Food and Drug Administration cleared the company’s SPRINT endura (single lead) and extensa (dual lead) Peripheral Nerve Stimulation Systems.

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Vertex cystic fibrosis drug gets expanded approval for use in infants

U.S. health regulators expanded the use of Vertex Pharmaceuticals Inc.’s cystic fibrosis drug Kalydeco to include patients aged between 12 months and 24 months.

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FDA Grants Breakthrough Therapy Designation for Xolair for Food Allergies

Genentech announced that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for Xolair (omalizumab) for the prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies.

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Amicus receives U.S. approval for Fabry disease drug

U.S. health regulators approved Amicus Therapeutics’ Galafold as the first oral therapy to treat Fabry disease, a rare and sometimes fatal condition.

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