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US FDA approves Bausch + Lomb and Novaliq’s DED treatment Miebo

Pharmaceutical Technology

It is the first and only prescription eye drop to receive FDA approval to treat DED that targets tear evaporation directly. Bausch + Lomb chairman and CEO Brent Saunders stated: “Today’s FDA approval of Miebo further advances DED treatment by addressing a significant unmet need for millions of people suffering with this disease. “We

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Lilly challenges Wegovy dominance in weight loss market with FDA approval

Pharmaceutical Technology

Zepbound (tirzepatide) has been approved by the FDA approval and is expected to be launched in the US by the end of 2023.

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US FDA approves Reata Pharmaceuticals’ SKYCLARYS for Friedreich’s ataxia

Pharmaceutical Technology

The FDA granted Orphan Drug, Fast Track, and Rare Pediatric Disease Designations for the medication. The European Medicines Agency (EMA) is also reviewing Reata’s marketing authorisation application (MAA) for SKYCLARYS in Europe. There are three more drug candidates with major trial readouts that are expected in 2023.

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US FDA approves Shorla’s oncology drug for T-cell leukaemia

Pharmaceutical Technology

The regulatory approval marks the company’s first product to receive approval in the US market. Shorla Oncology CEO and co-founder Sharon Cunningham said: “We are very proud to see our research in oncology innovation and dedication to patient care culminate in this US FDA approval.

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Bristol Myers' $4.1B Turning Point buy yields FDA approval for lung cancer drug Augtyro

Fierce Pharma

Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market. Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market. Watch out, Pfizer and Roche. Watch out, Pfizer and Roche.

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Lexicon gets FDA approval for Inpefa to treat heart failure

Pharmaceutical Technology

Lexicon senior vice president and chief medical officer Dr Craig Granowitz said: “With today’s FDA approval, Inpefa is now a valuable option for physicians to consider when treating patients transitioning out of the hospital and working to break the cycle of repeated hospitalisation.”

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US FDA approves Daiichi Sankyo-AstraZeneca’s Enhertu for lung cancer

Pharmaceutical Technology

A specifically engineered HER2-directed antibody drug conjugate (ADC), Enhertu is being co-developed and co-marketed by Daiichi Sankyo along with AstraZeneca. Enhertu is claimed to be the first HER2-directed therapy to receive approval for treating HER2 mutant metastatic NSCLC patients. In the trial, 1.9%