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.

FDA has granted regenerative medicine advanced therapy (RMAT) designation to Autolus’ CAR-T cell therapy obe-cel.

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.

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.

Takeda’s TAKHZYRO prefilled syringe is now available for patients with hereditary angioedema aged 12 years and older in the United States.

New guidance from FDA and legislation from Congress promote clinical trial diversity.

AmoyDX has entered a Master Collaboration Agreement with AstraZeneca for multiple companion diagnostics programs in China, EU, and Japan.

Thermo Fisher Scientific has launched its first GMP-manufactured Cas9 protein for clinical genome editing research.

High Purity New England has launched its third facility, focused on single-use assemblies.

GSK reaches agreement to acquire late-stage biopharmaceutical company Sierra Oncology for $1.9 billion.

Mylan Pharmaceuticals is issuing a voluntary recall of one batch of insulin glargine injection due to the potential for a missing label in the batch.