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- Read more about FDA-approved drug effectively treats rare chronic immune disorder
A drug approved to treat a severe form of asthma dramatically improved the health of people with rare chronic immune disorders called hypereosinophilic syndromes (HES) in whom other treatments were ineffective or intolerable. This finding comes from a small clinical trial led by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and conducted through a partnership with the global biopharmaceutical company AstraZeneca. The results were published online today in the New England Journal of Medicine.
- Read more about Acute flaccid myelitis requires galvanized research response
Acute flaccid myelitis (AFM) presents significant challenges not only to patients but also to researchers, and efforts must be accelerated to learn more about the condition, experts from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, write in a new perspective published in mBio.
- Read more about General, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders are increasing by 1.7% on 1 April 2019
General, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders are increasing by 1.7% on 1 April 2019. Full details of the new fee levels are available in Commission Regulation (EU) No 2019/480 amending Council Regulation (EC) No 297/95 , its implementing rules and the corresponding explanatory note on fees , published on 1 April 2019.
- Read more about FDA steps toward a new, tailored review framework for artificial intelligence-based medical devices
Artificial intelligence and machine learning have the potential to fundamentally transform the delivery of health care. As technology and science advance, we can expect to see earlier disease detection, more accurate diagnosis, more targeted therapies and significant improvements in personalized medicine.
- Read more about Indoco Remedies clears USFDA inspection
US Food and Drug Administration (USFDA), has cleared the sterile manufacturing facility of Indoco Remedies Limited, for Finished Dosages, located at Verna Industrial Area, Goa (Plant II). This inspection was carried out by USFDA in November 2018.

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- Read more about FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism
The U.S. Food and Drug Administration approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism. These men have low testosterone levels due to specific medical conditions, such as genetic disorders like Klinefelter syndrome or tumors that have damaged the pituitary gland.
- Read more about New EudraVigilance system improves reporting of side effects and detection of safety signals
The new and improved EudraVigilance, the European system for managing and analysing information on suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the EU, received more than 2 million reports of suspected side effects in 2018.
- Read more about 20 years of sampling and testing programme for medicines authorised for the EU
EMA and the European Directorate for the Quality of Medicines & Healthcare (EDQM) have reviewed EMA’s sampling and testing programme for centrally authorised medicines on the EU/EEA market, which has been organised yearly since 1998.
- Read more about FDA advances landmark policy changes to modernize mammography services and improve their quality
U.S. Food and Drug Administration announced important new steps to modernize breast cancer screening and help empower patients with more information when they are considering important decisions regarding their breast health care.
- Read more about NIH to test experimental drug to curb opioid cravings
A clinical trial of an experimental drug designed to treat cravings associated with opioid use disorder (OUD) has begun in the National Institutes of Health Clinical Center. The Phase I trial in healthy adults will assess the safety of the experimental compound, ANS-6637, and how it is processed in the body when given with another drug that is processed by the same liver enzyme pathway.