The U.S. Food and Drug Administration announced today the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas. Dengue is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands.
There has been a growing discussion in recent months around the safety of certain breast implants, with regulatory agencies around the world weighing the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). It’s an issue that has been a priority for us at the U.S. Food and Drug Administration since 2011 when we warned women that the available information at the time indicated that there is a risk for women with breast implants, especially those with textured implants, for developing this disease.
EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union (EU) for Sixmo (buprenorphine) as a substitution treatment for opioid dependence.
Biocon Ltd announced its consolidated financial results for the fourth quarter and fiscal year ended March 31st, 2019. Biocon Biologics revenue nearly doubled, led by biosimilars portfolio performance in developed and emerging markets. Branded Formulations India business reported a strong double digit growth which was offset by a decline in UAE. Generic Formulations business grew multi-fold off a low base, reflecting our focus on vertical integration in the Small Molecules business. Research Services subsidiary Syngene crossed the Rs 500 Crore Revenue milestone with a Net Profit milestone of Rs 100 Crore in Q4 on a standalone basis.
The United States faces a converging public health crisis as the nation’s opioid epidemic fuels growing rates of certain infectious diseases, including HIV/AIDS, hepatitis, heart infections, and skin and soft tissue infections. Infectious disease and substance use disorder professionals must work together to stem the mounting public health threat, according to a new commentary in the Journal of Infectious Diseases. The article was co-authored by officials from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Institute of Human Virology at the University of Maryland School of Medicine in Baltimore.
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.
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.
WHO is urging governments to enforce bans on tobacco advertising, promotion and sponsorship at sporting events, including when hosting or receiving broadcasts of Formula 1 and MotoGP events.
U.S. Food and Drug Administration issued a Letter to Health Care Providers to alert them that the agency is aware of an increasing number of medical device reports associated with the use of surgical staplers for internal use and implantable surgical staples common devices used in many surgeries and to provide updated recommendations to help reduce risks associated with their use.
EMA’s human medicines committee (CHMP) has adopted a positive opinion for Zynquista (sotagliflozin) intended as an adjunct to insulin for certain patients with type 1 diabetes mellitus.