Moderna

The U.S. Food and Drug Administration on Jan. 31 gave full approval to Moderna Inc.’s COVID-19 vaccine for people ages 18 and older, making Spikevax the second fully approved vaccine for the virus.

COVID-19 vaccines using mRNA technology do not affect fertility outcomes during in-vitro fertilization (IVF), researchers found. Other new findings suggest the bacteria living in the small intestine may contribute to the risk for long COVID after infection with SARS-CoV-2.

South San Francisco-based Cortexyme Inc. received a letter from the U.S. Food and Drug Administration on January 25 placing a full clinical hold on the Investigational New Drug application for the company’s lead clinical asset atuzaginstat, which is in development for the treatment of Alzheimer’s disease.

Pfizer released data from several studies showing that nirmatrelvir, the active main protease inhibitor of the company’s antiviral combination therapy Paxlovid (nirmatrelvir/ritonavir), is effective against the Omicron variant of SARS-CoV-2. Additionally, a study conducted by 23andMe and published in Nature Genetics identified a genetic risk factor tied to the loss of smell from COVID-19.

Pfizer building sign logo

The share price of Arena Pharmaceuticals nearly doubled in premarket trading after pharma giant Pfizer announced the acquisition of the company and its diverse portfolio of developmental and clinical assets – including a late-stage ulcerative colitis treatment – in an all-cash deal valued at $6.7 billion.

The U.S. Food and Drug Administration greenlit Xipere, the first suprachoroidal injectable medicine for macular edema associated with uveitis, co-developed by Clearside Biomedical and Bausch & Lomb.

Two years after spinning out from Japan’s Takeda, Phathom Pharmaceuticals is primed to take the company’s acid blocker to the U.S. market with another successful trial.

The U.S. Food and Drug Administration on Sept. 21 approved Incyte Corp.’s cream Opzelura for treating the inflammatory skin condition atopic dermatitis, commonly called eczema, in adolescents and adults with boxed warnings.

The U.S. drug regulator asked Pfizer, Eli Lilly and AbbVie to include information about the risks of serious conditions and death from the use of their drugs that belong to a class of treatments known as JAK inhibitors.

An advisory panel to the U.S. Centers for Disease Control and Prevention (CDC) on Aug. 30 unanimously recommended the Pfizer Inc. and BioNTech SE Covid-19 vaccine for people age 16 and older, an important step that could help accelerate vaccine mandates in the United States.