The US FDA has emphasized it will not make any changes to the recommended dosing of authorized COVID-19 vaccines: saying any modifications would create a ‘significant risk’ of undermining vaccination efforts.
The US Food and Drug Administration (FDA), in a review of Moderna’s COVID-19 vaccine candidate, found no safety concerns that would preclude the granting of emergency use authorization (EUA) for the vaccine in the US during the pandemic.
As the US FDA advisory committee meets to discuss the merits and risks of Pfizer/BioNTech’s application for emergency use of their COVID-19 vaccine candidate, we talk to two US legal experts to get their perspective on vaccine distribution stateside....
The US Food and Drug Administration (FDA) said there are ‘no specific safety concerns that would preclude issuance of an EUA’ for the investigational COVID-19 vaccine (BNT162b2) from US pharma giant, Pfizer, and its German partner BioNTech.
Regeneron’s casirivimab and imdevimab antibody cocktail (formerly known as REGN-COV2 or REGEN-COV2), has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).
Lilly's monoclonal antibody therapy, bamlanivimab (LY-CoV555), has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for the treatment of adults and children with recently diagnosed, mild to moderate COVID-19.
Regeneron has submitted a request for Emergency Use Authorization (EUA) for its REGN-COV2 investigational antibody combination for COVID-19: which was given to US President Donald Trump last week.
On Tuesday the FDA released its guidance on Emergency Use Authorization for COVID-19 vaccines: a move welcomed by the industry as a ‘tried and true tradition of releasing guidance in a public and transparent way’.
The release of the FDA guidance on emergency use authorization (EUA) for vaccines to prevent the spread of COVID-19 would provide regulatory clarity to scientists and strengthen public confidence in any vaccine authorized by the US regulator, says the...
In a deal valued at US$21bn, Gilead Sciences is to acquire Immunomedics Inc, a New Jersey headquartered biotech that has been highly focused on breast cancer drug innovation.
The chief executives of nine leading biopharma companies have moved to reassure the public over the development and testing procedures for Covid-19 vaccines.
Anti-competitive actions by companies hamper uptake of biosimilars, the US FDA suggests, and announces a series of actions that will be taken against them.
US FDA approves AstraZeneca’s at-home autoinjector for administration of an add-on treatment for severe asthma, matching the indication of GSK’s rival product, Nucala.
The FDA approves an IND application from ActoBio for AG017, an oral biologic drug candidate for the reversal of celiac disease, a condition which currently has no approved treatments.
Revance Therapeutics says developing a Botox biosimilar is “challenging, but not impossible” in reply to AbbVie’s dismissal of the prospect of a copy of the blockbuster coming to market.
The FDA approves targeted biologic, Dupixent, for the treatment of atopic dermatitis in patients 12 to 17 years old, the first treatment of its kind for adolescents.
Alleged manipulated and potentially inaccurate clinical data in the BLA for the $2.1m Zolgensma spark possibility for criminal penalties against AveXis.
Avastin biosimilar from Pfizer receives approval from the FDA for the treatment of five forms of cancers, increasing market competition for the originator drug.
Amgen’s biosimilars portfolio reaches a milestone after its Herceptin biosimilar, Kanjinti, developed in collaboration with Allergan, was approved by the US FDA.
Dupixent, Regeneron and Sanofi’s collaborative mAb treatment for eczema, has been approved by the European Commission for a new indication in severe asthma.
The US FDA approves an extended indication of GSK’s lupus treatment, Benlysta IV, for children five years and older, giving pediatric patients a new therapeutic option.
Novartis investigates the death of an infant in a gene therapy clinical trial to determine whether it was related to the treatment but does not anticipate an impact on FDA approval.
Following the US FDA issuing a CRL to Immunomedics, the agency has revealed its inspection found instances of data integrity breaches and manipulation.
The US market for insulin biosimilars is set to open up in 2020, and the head of biopharmaceuticals at Sandoz explained why he is confident of an ‘acceleration’ of the US biosimilar market in the coming years.
NICE recommends CAR T-cell treatment Kymirah to be covered by the Cancer Drugs Fund to treat adult patients with lymphoma, despite previous negative appraisals.
The US FDA is faced with lapsed funding appropriations as the US government shutdown continues, causing the agency to focus on addressing immediate threats to consumer safety.
Biosimilar approvals in the US have increased by 600% and with biologic patent expiration dates approaching, biosimilar applications are on the rise as well.
The US FDA has approved Genentech’s auto-injector formulation of Actemra, which the firm says offers an additional administration option for patients and caregivers.
