Salvat Laboratories announced that it has submitted a New Drug Application (NDA) to the FDA for the approval of the first ocular corticosteroid formulated in a nanoemulsion for inflammation and pain in post-ocular surgery patients.

This submission comes after two successful phase III clinical trials conducted between 2020 and 2021.

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a 30-µg booster dose of their Omicron BA.4/BA.5 bivalent-adapted COVID-19 vaccine (COMIRNATY® Original/Omicron BA.4/BA.5 15/15 µg) has been recommended for conditional marketing authorization (cMA) by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals ages 12 years and older.

BioNTech SE (Nasdaq: BNTX, "BioNTech") published an official statment: "BioNTech is aware of reports that Moderna has sued Pfizer and BioNTech, alleging that COMIRNATY® infringes certain Moderna patents. BioNTech's work is original, and we will vigorously defend against all allegations of patent infringement.

Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today is filing patent infringement lawsuits against Pfizer and BioNTech in the United States District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany.

BioNTech SE (Nasdaq: BNTX, "BioNTech") announced initial data from an ongoing investigator-initiated first-in-human Phase 1 study evaluating the safety and tolerability of the mRNA-based individualized neoantigen specific immunotherapy (iNeST) autogene cevumeran (also known as BNT122, RO7198457) in combination with anti-PD-L1 immune checkpoint inhibitor atezolizumab and chemotherapy in patients with resected pancreatic ductal adenocarcinoma (PDAC).

The profound health and economic impact of the Pfizer-BioNTech vaccine during its first year of rollout in the US is described in detail in a new study in the peer-reviewed Journal of Medical Economics.

It is estimated that in 2021 the vaccine, the most widely used against COVID-19 in the US, prevented 8.7 million symptomatic cases of the virus, as well as 690,000 hospitalizations and more than 110,000 deaths.

Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") announced they have reached an agreement with the European Commission (EC) to amend their originally agreed contractual delivery schedules for the Pfizer-BioNTech COVID-19 Vaccine.