Wanted: better policies and incentives to revitalise R&D for new antimicrobial drugs

15 October 2019 - In the not-too-distant future that we could be facing — one with rampant, uncontrollable, multidrug-resistant microbes ...

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Faced with a drug shortfall, doctors scramble to treat children with cancer

14 October 2019 - A critical chemotherapy medication is in short supply, and physicians say there is no appropriate substitute. ...

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U.S. FDA approves Secuado (asenapine) transdermal system, the first-and-only transdermal patch for the treatment of adults with schizophrenia

15 October 2019 - Noven Pharmaceuticals today announced the U.S. FDA has approved Secuado (asenapine) transdermal system, the first-and-only transdermal patch ...

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Patient experience data: researchers call for more consistency from FDA

14 October 2019 - Researchers at drug maker Sanofi are calling on the US FDA to make its publication of ...

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Xenikos receives FDA fast track designation for T-Guard(R) for treating steroid-refractory acute graft-versus-host disease

14 October 2019 - Xenikos is currently preparing to initiate a U.S. pivotal Phase 3 trial. ...

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Akorn receives FDA approval for betamethasone dipropionate 0.05% lotion USP (augmented)

14 October 2019 - Akorn today announced that it received a new abbreviated new drug application approval from the U.S. ...

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Flexion Therapeutics announces extended FDA review of supplemental new drug application for Zilretta

14 October 2019 - Flexion Therapeutics today announced that the U.S. FDA has informed the company it needs additional time ...

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FDA bid to bolster generic competition and combat shortages isn’t working — yet

14 October 2019 - Although the FDA has maintained that additional generic approvals should promote competition and alleviate shortages, the ...

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FDA is smashing the status quo for regulatory science

14 October 2019 - A recent press release from the FDA titled “Reorganization of the Office of New Drugs with ...

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U.S. FDA approves Xarelto (rivaroxaban) to help prevent blood clots in acutely ill medical patients

14 October 2019 - Xarelto provides a new oral option to help prevent venous thromboembolism (VTE) and VTE-related death during hospitalisation ...

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Have FDA’s generic approvals helped with competition? Researchers say too early to tell

11 October 2019 - Amid increasing abbreviated new drug application approvals, efforts by the US FDA to promote generic drug development ...

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FDA approves new treatment for patients with migraine

11 October 2019 - The U.S. FDA today approved Reyvow (lasmiditan) tablets for the acute (active but short-term) treatment of migraine ...

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MSF demands Johnson & Johnson reduce price of life saving TB drug

11 October 2019 - Pharma company Johnson and Johnson sell TB drug bedaquiline for nearly US$1,200 per treatment course, a price ...

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Pharma industry is 'right in the crosshairs,' Merck CEO Kenneth Frazier says

11 October 2019 - President Donald Trump and House Speaker Nancy Pelosi are in a battle over impeachment but their ...

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FDA grants FX-322 fast track designation

10 October 2019 - The company also announced today that the U.S. FDA has granted fast track designation for FX-322.  ...

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