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Vizz (Lenz Therapeutics) is the first and only aceclidine-based eye drop for presbyopia and is also the first daily solution to correct vision for up to 10 hours.
The FDA has approved a medical device that stimulates the vagus nerve for the treatment of moderate-to-severe rheumatoid arthritis (RA) in patients who have not responded to — or cannot tolerate — ...
The once-weekly injection, already approved in pediatric patients with GHD, offers convenience over daily injections.
The FDA has approved Skytrofa (lonapegsomatropin-tcgd) for the replacement of growth hormone in adults with GHD.
The FDA has extended the review period for elinzanetant for the treatment of moderate to severe vasomotor symptoms due to menopause.
After losing 3,500 employees in April—19% of its workforce due to congressional budget cuts—the FDA is now struggling to meet ...
US FDA extends review period for Bayer’s NDA for elinzanetant to treat moderate to severe VMS due to menopause: Berlin Monday, July 28, 2025, 16:00 Hrs [IST] Bayer announced tha ...
Berlin: Bayer has announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug ...
These two Food and Drug Administration-approved drugs for cancer treatment may hold the key to reversing Alzheimer's disease ...
The US Food and Drug Administration (FDA) has notified Bayer that it has extended the review period for the New Drug ...
The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and the U.K. have already cleared it for use.
Bayer announced an FDA review extension for Elinzanetant, its experimental menopausal hot flash therapy. Approval remains on track. REad more here.