Submit RFI/RFP
Request Consultation
FeaturedFDA Enables Increased Access of Syphilis Diagnosis
First Home Antibody Test Can Inform Patients of Current or Past Infection and Lead to Confirmatory Testing with Health Care Provider, The U.S. Food and Drug Administration granted…
Newsroom
News
301 articles
Featured
FeaturedEMA supports pilot for joint African continental assessment procedures
Validating processes is an important step towards establishment of African Medicines Agency, EMA has awarded a grant to the African Medicines Regulatory Harmonisation (AMRH) initiative of the African…
ImportantFDA Approves First Nalmefene Hydrochloride Auto-Injector to Reverse Opioid Overdose
The U.S. Food and Drug Administration approved Zurnai, the first nalmefene hydrochloride auto-injector for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients…
FeaturedFDA Approves First Gene Therapy to Treat Adults with Metastatic Synovial Sarcoma
The U.S. Food and Drug Administration approved Tecelra (afamitresgene autoleucel), a gene therapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received…
FeaturedMHRA approves JN.1 COVID-19 vaccine for adults and children from infancy
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an adapted Pfizer/BioNTech COVID-19 vaccine (Comirnaty) that targets the JN.1 COVID-19 subvariant. This vaccine triggers the production of…
FeaturedMHRA approves semaglutide to reduce risk of serious heart problems in obese or overweight adults
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication for semaglutide (Wegovy) to reduce the risk of overweight and obese adults suffering serious heart…
FeaturedMHRA approves the Raltegravir (first generic) medicines to treat adult and paediatric patients infected by HIV
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the first generic raltegravir medicines to treat adult and paediatric HIV patients who weigh at least 40kg. The…
ImportantSafety update on Epimax Ointment and Epimax Paraffin-Free Ointment: reports of ocular surface toxicity and ocular chemical injury
Epimax Ointment and Epimax Paraffin-Free Ointment can harm the eyes if used on the face. Do not prescribe these ointments for use on the face. Tell patients to…
FeaturedMHRA approves vibegron to treat adult patients with Overactive Bladder Syndrome (OAB)
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 17 July 2024, approved the medicine vibegron (Obgemsa) to treat the symptoms of overactive bladder (OAB) syndrome in…
FeaturedCapivasertib approved to treat patients with advanced breast cancer
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 17 July 2024, approved the medicine capivasertib (Truqap) for patients with advanced hormone receptor (HR) positive, human epidermal…
FeaturedOcrelizumab injection approved for multiple sclerosis treatment in adults
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new formulation of the medicine ocrelizumab (Ocrevus 920mg solution for injection) to treat relapsing forms of multiple…
ImportantSafety alert about compounded colic preparations containing Atropa belladonna use in infants and children
The TGA has received reports of serious adverse events in infants and children who have been given compounded wind and colic preparations containing Atropa belladonna (belladonna). We are…
FeaturedFDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test
Today, the U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first hepatitis C virus (HCV) test…
FeaturedTopiramate-related new pregnancy prevention measures announced
Migraine and antiseizure medication topiramate must no longer be prescribed to women and girls unless they fulfil the requirements of a Pregnancy Prevention Programme. Following a major safety…
ImportantFirst nasal adrenaline spray (Eurneffy) for emergency treatment against allergic reactions
Eurneffy (epinephrine) is an alternative to injectable formulations, EMA’s human medicines committee (CHMP) has recommended granting a marketing authorization in the European Union for Eurneffy (epinephrine), the first…
Ready to simplify your journey?
Talk to our experts and get tailored solutions to help you stay compliant and move forward with confidence.
Submit RFI/RFP