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FDA Lifts Partial Clinical Hold for Mersana’s XMT-1522

Mersana Therapeutics Inc. announced that the U.S. Food and Drug Administration lifted the partial clinical hold on the Phase 1 study of the experimental cancer drug XMT-1522.

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U.S. regulator approves Teva migraine drug, shares rise

Shares of Israeli drugmaker Teva Pharmaceutical Industries rose more than 5 percent after the U.S. Food and Drug Administration approved the company’s new migraine treatment.

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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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FDA Grants Breakthrough Therapy Designation for Concentric Analgesics’ CA-008 in Post-Surgical Pain

Concentric Analgesics Inc. announced today that the clinical-stage biopharmaceutical company received Breakthrough Therapy designation from the U.S. Food and Drug Administration for CA-008 in post-surgical pain.

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Merck’s Keytruda chemo cocktail wins EU approval

Merck & Co.’s key cancer drug Keytruda was approved for use in Europe in combination with chemotherapy in previously untreated lung cancer patients.

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GSK says U.S. FDA wants more information on pulmonary drug

GlaxoSmithKline said U.S. health authorities asked for more information about the company’s Nucala drug for use in combating chronic obstructive pulmonary disease (COPD).

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Tezepelumab Granted Breakthrough Therapy By FDA

Amgen and AstraZeneca announced that the U.S. FDA granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma without an eosinophilic phenotype.

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J&J to work with India on compensation for recalled hip implants

Johnson & Johnson said the company would work with the Indian government to compensate patients who had suffered from hip implants that were recalled by the U.S. healthcare firm eight years ago after data showed high failure rates.

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Akcea Therapeutics to cut about 10 percent of workforce

Akcea Therapeutics Inc. planned to cut its workforce by about 10 percent after the U.S. health regulator declined to approve the company’s Waylivra drug for treating a genetic disease that causes fat accumulation in blood.

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FDA extends review of Roche’s Tecentriq by 3 months

Roche said the U.S. FDA extended by three months the review period for Tecentriq in combination therapy as a first-line treatment for a form of lung cancer.

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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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CDC reports 30 more cases of illnesses linked to Kellogg’s tainted cereal

Thirty more people were reported sick after eating Kellogg Co.’s Honey Smacks cereal contaminated with Salmonella, the Centers for Disease Control and Prevention (CDC) said, bringing the total to 130 cases in 36 states.

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Sanofi wins European approval for rare blood-clotting disorder treatment

The French drugmaker Sanofi secured approval in Europe for a rare blood-clotting disorder treatment using nanobodies.

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FDA approves two new HIV drugs from Merck

The U.S. FDA approved two of Merck & Co. Inc.’s HIV oral drugs nearly two months ahead of schedule.

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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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FDA warns of serious genital infection linked to certain diabetes drugs

The U.S. FDA said a serious genital infection was reported in patients taking a certain class of diabetes drugs, with one death and 11 others hospitalized.

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FDA Warns 21 More Websites Marketing Unapproved Opioids

The U.S. Food and Drug Administration warned four online networks that operate 21 websites selling opioids online.

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FDA declines to approve Akcea-Ionis genetic disease drug

The U.S. FDA declined to approve a drug from Akcea Therapeutics and Ionis Pharmaceuticals that aims to treat a genetic disease that causes fat accumulation in the blood.

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