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US approves Alzheimer’s drug

eAwaz Medicine

WASHINGTON (AFP) The US Food and Drug Administration has approved a highly anticipated new drug designed to slow cognitive decline in patients in mild and early stages of Alzheimer’s disease. The FDA approval of the drug, Leqembi, also known as lecanemab, comes just days after the regulatory agency was harshly criticised in a congressional report for its green-lighting of another Alzheimer’s …

Pfizer BioNTech COVID 19 vaccine

Pfizer/BioNTech gets positive response for Omicron BA.4/BA.5-Adapted Bivalent Vax in EU

eAwaz Medicine

NEW YORK & MAINZ – Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a 30-µg booster dose of their Omicron BA.4/BA.5 bivalent-adapted COVID-19 vaccine (COMIRNATY® Original/Omicron BA.4/BA.5 15/15 µg) has been recommended for conditional marketing authorization (cMA) by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals ages 12 years and older. The European …

tecovirimat

Experimental monkeypox pills Tpoxx not available

eAwaz Medicine

LA – The monkeypox drug is not readily available. The US Food and Drug Administration has not approved tecovirimat — sold under Tpoxx brand for treating monkeypox but the US Centers for Disease Control and Prevention is making the drug available under Strategic National Stockpile. However, people are still facing challenges to get it.

alopecia areata

FDA, pill alopecia treatment 

eAwaz Medicine

Washington- The US Food and Drug Administration has recently approved baricitinib as the first oral tablet for treating severe alopecia areata, an autoimmune disorder. The disease affects over 300,000 people in the United States every year and causes temporary or permanent patchy hair loss. The disease came under the scanner after Hollywood actress Jada Pinkett Smith and congresswoman Ayanna Pressley …

Novavax

Concerns of myocarditis risk for Novavax’s Covid vax

eAwaz Health

Washington – The US Food and Drug Administration says Novavax’s protein-based vaccine is effective against Covid-19 but has shown concerns over its risk of myocarditis and pericarditis. It said: “These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID-19 vaccines.”

remdesivir

FDA gives nod for remdesivir for young children

eAwaz Medicine

Washington – The US Food and Drug Administration has announced it has expanded approval of the Covid-19 drug remdesivir to treat patients as young as 28 days and weighing about 7 pounds. This is the first Covid-19 treatment approved for children younger than 12. To be eligible for treatment, the FDA said, children must be hospitalized or have mild to …

Ondexxya

Ondexxya approved in Japan for reversal of acute major bleeds in patients on Factor Xa inhibitors

eAwaz Medicine

London – Ondexxya (andexanet alfa) has been approved in Japan for patients treated with the Factor Xa (FXa) inhibitors apixaban, rivaroxaban or edoxaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. The approval by the Japanese Ministry of Health, Labour and Welfare was based on positive results from the  ANNEXA-4  Phase III clinical trial showing Ondexxya rapidly and markedly reversed anti-FXa activity in patients with acute major bleeding. Ondexxya is the first approved …