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The novel combination of albuterol and budesonide in AstraZeneca’s PT027 reduced the risk of severe asthma flare-ups by 27 percent in patients with moderate-to-severe asthma, according to results from a late-stage study. Read More
The FDA has approved Eli Lilly’s Mounjaro (tirzepatide) injection as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The approval marks the first new class of drugs for type 2 diabetes in 10 years. Read More
A two-week course of Gilead’s investigational HIV-1 drug, lenacapavir, followed by twice-yearly injections, almost completely suppressed viral load in patients with multidrug-resistant infections. Read More
The FDA issued over-the-counter (OTC) drug and cosmetic manufacturer Allure Labs a four-observation Form 483 following a November to December 2021 inspection of its Hayward, Calif., facility, noting procedural lapses and possible underreporting of deviations, nonconformances and out-of-specification (OOS) events. Read More
A group of generic drugmakers pledged to manufacture versions of Pfizer’s COVID-19 antiviral pill Paxlovid (nirmatrelvir/ritonavir) for use in the developing world and agreed to price them at $25 or less per treatment course. Read More
UCB drew a Complete Response Letter (CRL) from the FDA rejecting the company’s Biologics License Application (BLA) for its investigational monoclonal antibody drug bimekizumab in adult patients with moderate-to-severe plaque psoriasis. Read More