FDA limits use of Janssen COVID-19 vaccine to certain individuals
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The U.S. Food and Drug Administration has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.
EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice
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- Category: EMA
EMA, in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC), has launched the Cancer Medicines Forum (CMF). Bringing together representatives from academic organisations and the European medicines regulatory network, the forum aims at advancing research into optimising cancer treatments and will contribute to foster high standards in cancer care in the European Union (EU).
FDA approves first generic of Symbicort to treat asthma and COPD
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Today, the U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions: asthma in patients six years of age and older; and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
FDA approves treatment for wider range of patients with heart failure
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Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults.
Jardiance was originally approved by the FDA in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes.
EMA: Human medicines highlights of 2021
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- Category: EMA
In 2021, EMA recommended 92 medicines for marketing authorisation. Of these, 53 had a new active substance which had never been authorised in the European Union (EU) before. This is a 35% increase compared to the 39 medicines with a new active substance that were authorised in 2020. The overview of key recommendations in 2021 includes figures on the authorisation of medicines and a selection of new treatments that represent significant progress in their therapeutic areas.
FDA takes key action by approving second COVID-19 vaccine
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Today, the U.S. Food and Drug Administration approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older.
FDA authorizes additional oral antiviral for treatment of COVID-19 in certain adults
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The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Merck's molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.
More Pharma News ...
- FDA authorizes first oral antiviral for treatment of COVID-19
- FDA expands eligibility for Pfizer-BioNTech COVID-19 booster dose to 16- and 17-year-olds
- FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 through 11 years of age
- FDA, NIH, and 15 private organizations join forces to increase effective gene therapies for rare diseases
- FDA takes additional actions on the use of a booster dose for COVID-19 vaccines
- FDA awards 11 grants to clinical trials to develop new medical products for rare disease treatments
- FDA approves innovative treatment for pediatric patients with congenital athymia