News

FDA delays approval decision for Bayer menopause therapy
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.
Revalesio Receives FDA Fast Track Designation for RNS60 for the Treatment of Acute Ischemic Stroke
Revalesio, a clinical-stage biopharmaceutical company developing treatments for acute and chronic neurological disorders, today announced that the U.S. Food and Drug Administration has granted Fast ...
The Manila Times3d
FDA Approves SKYTROFA® (Lonapegsomatropin-tcgd) for the Once-Weekly Treatment of Adults with Growth Hormone Deficiency
First of many planned label expansions supporting Vision 2030 goal to become the leading endocrinology rare disease companyOn track to initiate basket trial for ISS, SHOX deficiency, Turner syndrome, ...
RedHill Receives Positive FDA Feedback on Pathway to Approval of Groundbreaking RHB-204 for Crohn's Disease
RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it received positive feedback from the U.S. Food and Drug Administration ...
Sarepta will resume gene therapy shipments after FDA review of recent patient death
Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping ...
Biocon Biologics Expands Diabetes Portfolio With FDA Approval Of Kirstytm, The First And Only Interchangeable Rapid-Acting Insulin Aspart In The United States
BRIDGEWATER, N.J., United States and BENGALURU, Karnataka, India, July 15, 2025 (GLOBE NEWSWIRE) -- Biocon Biologics Ltd (BBL) , a fully int ...
TMCnet1d
Bioventus Receives FDA 510(k) Clearances for two Next-Generation Peripheral Nerve Stimulation Products
These two clearances mark an important step forward for Bioventus and represent a substantial growth opportunity as the Company looks to expand in the PNS market, which is currently estimated to be ...
News-Medical.Net on MSN1h
AI uncovers new lipid-lowering effects in existing FDA-approved drugs
In a breakthrough for cardiovascular medicine, researchers have harnessed artificial intelligence to discover unexpected ...
FDA commissioner predicts ‘record’ drug approvals this year
FDA Commissioner Marty Makary said the FDA’s review process will not slow down despite layoffs at the Department of Health ...
FDA vaccine chief leaving agency after less than 3 months
Dr. Vinay Prasad is stepping down as the Food and Drug Administration's top vaccine regulator after a brief tenure.
Food Safety News1d
The FDA recommends scheduling kratom’s 7-OH under the Controlled Substances Act
Gas station heroin” took another hit on Wednesday as HHS Secretary Robert F. Kennedy Jr’s FDA recommended a scheduling action ...