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

Pharmaceutical Technology

SKYCLARYS is the first approved treatment in Friedrich’s Ataxia and marks a milestone for drug development in this complex disease. There are three more drug candidates with major trial readouts that are expected in 2023. The FDA granted Orphan Drug, Fast Track, and Rare Pediatric Disease Designations for the medication.

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US FDA approves Regeneron-Sanofi’s Kevzara to treat polymyalgia rheumatica

Pharmaceutical Technology

“With the approval of Kevzara for polymyalgia rheumatica, patients now have an FDA-approved treatment to help offer relief from the disabling symptoms of this disease and long-term dependence on steroids.”

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US FDA approves Pfizer’s migraine nasal spray Zavzpret

Pharmaceutical Technology

The company stated that the regulatory approval expands its migraine portfolio, which includes oral therapy for acute and preventive treatment. The regulator granted the approval based on two pivotal placebo-controlled, double-blind, randomised trials. The company expects to launch Zavzpret in pharmacies in July.

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Oryzon wins FDA approval to begin SCLC treatment trial

Pharmaceutical Technology

The Phase I/II trial will assess iadademstat in combination with immune checkpoint inhibitors in lung cancer patients.

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FDA panel votes against MDMA therapy for PTSD, citing muddy data and safety concerns

Bio Pharma Dive

A group of independent experts wasn't convinced by clinical trial data from company Lykos Therapeutics, which is seeking FDA approval of MDMA-assisted treatment for post-traumatic stress disorder.

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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.”