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Pfizer and BioNTech submit Phase I data to FDA for COVID-19 booster
Pfizer and BioNTech have announced the submission of initial data to the US FDA to support booster dose of COVID-19 vaccine.
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US Food and Drug Administration (FDA)
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FDA approves TicoVac™ tick-borne encephalitis (TBE) vaccine
The FDA has approved Ticovac, a tick-borne encephalitis (TBE) vaccine, for people aged one year and older when travelling to TBE endemic areas.
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FDA approve a new indication for Xywav to treat chronic sleep disorder
The FDA have granted a first of its kind indication for Xywav for the treatment of idiopathic hypersomnia (IH) in adults.
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Lebrikizumab displays 75 percent skin clearance in dermatitis patients
Lebrikizumab achieved at least 75 percent skin clearance in more than half of patients with atopic dermatitis (AD), shows Phase III study.
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FDA allows additional COVID-19 vaccine dose for immunocompromised
The FDA has authorised an additional dose of COVID-19 Vaccines Pfizer-BioNTech and Moderna in certain immunocompromised patients.
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Advances in technology and manufacturing to promote plant-produced therapeutics uptake
Experts suggest investing in plant-based manufacturing systems could reduce costs and help scale up therapeutic protein manufacturing.
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FDA releases guidance for near infrared (NIR) analytical procedures
New final guidance will aid drug developers in developing, validating, applying and submitting near infrared (NIR) spectroscopy-based analytical procedures.
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Ritlecitinib improves scalp hair regrowth in alopecia trial
Ritlecitinib was shown to reduce scalp hair loss to less than or equal to 20 percent after six months in Pfizer’s Phase IIb/III trial.
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FDA Fast Track designation given to mRNA RSV vaccine
Moderna’s mRNA respiratory syncytial virus (RSV) vaccine candidate, mRNA-1345, gains Fast Track designation in adults over 60 years old.
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Saphnelo approved to treat systemic lupus erythematosus
AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for patients with moderate to severe systemic lupus erythematosus.
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FDA approves emergency use of REGEN-COVTM for COVID-19 prevention
The FDA have authorised REGEN-COV monoclonal antibody therapy for emergency use as prevention for COVID-19 in certain patients.
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FDARA implementation guidance for paediatric studies of molecularly targeted oncology drugs
This article addresses early planning for paediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original New Drug Application (NDAs) and Biological License Application (BLAs) are expected to be submitted to FDA, in accordance with The FDA Reauthorization Act (FDARA).
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Biden Administration to support resilience of US pharma supply chain
US President announces $60 million in funding to support domestic API production and a consortium to onshore essential medicine manufacturing.
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FDA approves first interchangeable biosimilar insulin product
The first interchangeable biosimilar insulin product will help increase access and affordability of insulin for diabetics.
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Regulators call for clinical research to include pregnant and breastfeeding women
The FDA and other global regulators are co-operating to address inadequacies in clinical research that leave pregnant and breastfeeding women lacking data on which to base their medical decisions.
