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Relief for Amylyx as FDA clears controversial ALS drug Relyvrio

pharmaphorum

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. An oral version of edaravone was cleared this year. The organisation contributed $2.2

FDA 82
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Collaboration with Janssen and Eli Lilly to address lack of paediatric medications

Pharmaceutical Technology

In recent years, with the advent of biologics and novel therapeutic targets such as anti-TNF, anti-interleukin, and anti-integrin, there has been a steady increase in the number of agents approved to treat inflammatory bowel diseases (IBD), which has provided physicians with an increasing number of options to treat Crohn’s disease (CD).

Medical 59
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Competition is on the horizon for costly narcolepsy treatments

pharmaphorum

Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. In 2020, the FDA-approved indication was expanded to include those patients who suffer from cataplexy.

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The future of medical cannabis development in Europe

European Pharmaceutical Review

In many European countries physicians can now prescribe medical cannabis for an array of chronic health conditions, including chronic pain, mental health disorders and neurological conditions. It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA).

Medical 81
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How one pharma “family business” places patients first

pharmaphorum

There are many challenges in the development of therapies for rare diseases due to several unique factors, including small target patient populations, lack of long-term safety and efficacy data or natural history data, and often complex administration, dosing, and patient monitoring requirements,” Chiesi says.

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OSSIO Announces U.S. Launch and First Commercial Use of OSSIOfiber® Suture Anchors

Legacy MEDSearch

OSSIOfiber Suture Anchors were FDA cleared in March 2022 for use in “fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow” in a variety of specific orthopedic procedures. OSSIO is an orthopedic fixation company committed to transforming the orthopedic experience for patients, physicians and payors.