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Drug Approvals On October 8, 2025, the U.S. Food and Drug Administration (FDA) approved Libtayo (cemiplimab-rwlc) as an adjuvant treatment for adults with cutaneous squamous cell carcinoma (CSCC) at high…
Drug Approvals The Saudi Food and Drug Authority (SFDA) has approved the registration of Qalsody (tofersen) for the treatment of adults with amyotrophic lateral sclerosis (ALS) linked with mutations in…
Warnings The U.S. Food and Drug Administration (FDA) is taking proactive steps to protect public health following alarming reports of diethylene glycol (DEG) and ethylene glycol (EG) contamination in…
Trending topics The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have announced the early rollout of their accelerated aligned pathway…
Drug Approvals The U.S. Food and Drug Administration (FDA) has approved lurbinectedin (Zepzelca) in combination with atezolizumab (Tecentriq), or with atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza), as a maintenance treatment for…
Warnings The European Medicines Agency (EMA) has announced new safety measures for finasteride- and dutasteride-containing medicines to decrease the risk of suicidal ideation. These updates aim to increase awareness…
Important The SFDA launched a dedicated webpage on its website that provides access to draft guidelines under development for public consultation and private sector feedback, along with the officially…
Trending topics On October 3, 2025, the FDA launched a pilot prioritization program to speed up the review of abbreviated new drug applications (ANDAs) for companies that manufacture and test…
Drug Approvals On September 25, 2025, the U.S. Food and Drug Administration granted approval to imlunestrant for adults with estrogen receptor (ER)–positive, HER2–negative, ESR1-mutated advanced or metastatic breast cancer who…
Drug Approvals Acromegaly patients now have new hope after FDA recently approved Palsonify to treat adults who weren’t able to undergo surgery or had limited response to surgery, giving them…
Trending topics The U.S. Food and Drug Administration (FDA) has authorized the marketing of Essilor Stellest eyeglass lenses, the first glasses designed to both correct nearsightedness (myopia) and slow its…
Important The Medicines and Healthcare products Regulatory Agency (MHRA), alongside the Advertising Standards Authority (ASA) and the General Pharmaceutical Council (GPhC), has issued an updated Enforcement Notice clarifying rules…
Warnings April to June 2025 saw the FDA’s Adverse Event Reporting System (FAERS) report a series of possible safety signals and new serious risk warnings for a range of…
Important The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that there is no evidence linking paracetamol use during pregnancy to autism in children. Dr Alison Cave, Chief…
Drug Approvals On September 19, 2025, the U.S. Food and Drug Administration (FDA) approved Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph, Merck) for subcutaneous injection. It is the first approval of…
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