Accelerate Diagnostics’ new blood culture kit demonstrated 94% or greater accuracy on positive blood cultures relative to matrix-assisted laser desorption/ionization (MALDI).

FDA’s Office of Compliance has released its 2021 Annual Report, which highlights the agency’s successes in public health.

FDA has issued the final guidance on electronic postmarketing safety reports in a series of guidance documents.

VYDURA has been granted marketing authorization by the European Commission for both acute treatment of migraine and prophylaxis of episodic migraine.

Moderna has filed for emergency use authorization of its COVID-19 vaccine for use in young children six months to under six years of age.

A long-running criminal case involving the theft of confidential data from a pharma giant is still unravelling, as more convictions are made.

What are the next steps for permanent authorization of COVID-19 vaccines, treatments, and diagnostics?

ENHERTU has been granted breakthrough therapy designation in the US for patients with HER2 low metastatic breast cancer.

Fresh insight is instrumental in the discussion of novel analytics.

Spring has returned, and with it comes INTERPHEX.

Bio-Rad Laboratories introduces three new fluorescent dyes under the StarBright product range to support multicolor flow cytometry panels.

A new range of five instruments for ultra-low-volume liquid dispensing for microarray and microfluidics applications, Mercury, has been introduced by Arrayjet.

CN Bio’s PhysioMimix “in-a-box” reagent kit is designed to harness liver-on-a-chip technology to improve accuracy and efficiency in drug discovery.

Societal CDMO has been awarded a new manufacturing and packaging task order agreement by National Cancer Institute.

Thermo Fisher Scientific has expanded its state-of-the-art R&D facility in Hyderabad, India.

GeoVax has received a patent for its malaria vaccine from the US Patent and Trademark Office.

Pfizer and BioNTech have submitted an application for Emergency Use Authorization for a COVID-19 vaccine booster dose in young children.

Johnson & Johnson has launched its next Satellite Center for Global Health Discovery at Holistic Drug Discovery and Development Centre, University of Cape Town.

Tremelimumab has been accepted under priority review in the US for patients with unresectable liver cancer in combination with Imfinzi.

FDA has approved Veklury to treat COVID-19 in pediatric patients under 12 years of age.

Pfizer has issued a voluntary nationwide recall of lots of Accupril due to N-nitroso-quinapril content.

EMA is recommending EU conditional approval of Roche’s potential first-in-class bispecific antibody mosunetuzumab for people with relapsed or refractory follicular lymphoma.

EMA has granted Novo Nordisk a positive scientific opinion on human insulin with more flexible storage without refrigeration.

FDA is requesting comment on draft document “Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange.”

FDA has approved commercial production at Kite’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland.

Catalent will invest $350 million into integrated biologics drug substance and drug product manufacturing at Bloomington, Indiana facility.

The European Investment Bank has provided €15 million to fund coronavirus research at IRBM.

Otsuka Pharmaceutical and Osaka University have entered an exclusive license agreement on a new anti-tumor antibody.