Regulatory Affairs News Channel

FDA updates warnings for fluoroquinolone antibiotics

FDAThe U.S. Food and Drug Administration today approved safety labeling changes for a class of antibiotics, called fluoroquinolones, to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections.

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FDA approves new medication for dry eye disease

FDAThe U.S. Food and Drug Administration approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry eye disease, on Monday, July 11, 2016. Xiidra is the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 (LFA-1) antagonist, approved by the FDA for dry eye disease.

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FDA advances Precision Medicine Initiative by issuing draft guidances on next generation sequencing-based tests

FDAIn support of the President’s Precision Medicine Initiative, the U.S. Food and Drug Administration has issued two draft guidances that, when finalized, will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a person's genomic makeup.

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FDA targets unlawful internet sales of illegal prescription medicines during International Operation Pangea IX

FDAThe U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, announced that it took action this week against 4,402 websites that illegally sell potentially dangerous, unapproved prescription drugs to U.S. consumers.

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FDA approves first buprenorphine implant for treatment of opioid dependence

FDAThe U.S. Food and Drug Administration today approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.

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FDA approves new treatment for inhalation anthrax

FDAOn Friday, March 18, the U.S. Food and Drug Administration approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Anthim is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

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Launch of PRIME - Paving the way for promising medicines for patients

EMAThe European Medicines Agency (EMA) has launched its new PRIME (PRIority MEdicines) scheme to strengthen support to medicines that target an unmet medical need. The scheme focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients with no treatment options. These medicines are considered priority medicines within the European Union (EU).

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Novo Nordisk and Aarhus University …

Novo Nordisk and Aarhus University's Science and Technology faculty today signed a collaboration agreement to strengthen protein technology research and development. Unde...

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AstraZeneca enters licensing agreem…

AstraZeneca today announced that it has entered into agreements that support its strategic focus on three main therapy areas; Respiratory, Inflammation and Autoimmunity, ...

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Bristol-Myers Squibb acquires Cormo…

Bristol-Myers Squibb Company (NYSE:BMY) and Cormorant Pharmaceuticals announced today that Bristol-Myers Squibb has acquired all of the outstanding capital stock of Cormo...

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Bristol-Myers Squibb and PsiOxus Th…

Bristol-Myers Squibb Company (NYSE: BMY) and PsiOxus Therapeutics, Ltd. (PsiOxus) today announced an exclusive clinical collaboration agreement to evaluate the safety, to...

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Sanofi Pasteur signs research agree…

Sanofi and its vaccines global business unit Sanofi Pasteur announced today a Cooperative Research and Development Agreement with the Walter Reed Army Institute of Resear...

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FDA advances Precision Medicine Ini…

In support of the President’s Precision Medicine Initiative, the U.S. Food and Drug Administration has issued two draft guidances that, when finalized, will provide a fle...

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Merck and Pfizer initiate Phase III…

Merck KGaA, Darmstadt, Germany, and Pfizer (NYSE: PFE) have announced the initiation of a Phase III study, JAVELIN Ovarian 100, to evaluate the efficacy and safety of ave...

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Twisting and turning to target anti…

Researchers are getting closer to understanding how some natural antibiotics work so they can develop drugs that mimic them. A recent review commissioned by the British g...

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Merck commits €1.5 million to the G…

Merck, a leading science and technology company, today announced it would continue to support the advancement of medical science in the field of fertility through the Gra...

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FDA approves first and only single …

Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the Repatha® (evolocumab) PushtronexTM system (on-body infusor with pref...

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Scientists are starting to accumulate huge datasets on which genes mutate during cancer, allowing for a more systematic approach to "precision medicine." In a study publi...

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Amgen and Daiichi Sankyo announce a…

Amgen (NASDAQ:AMGN) and Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo; TSE 4568) today announced the execution of an exclusive agreement to commercialize nin...

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