Latest FDA News

FDA confirms diagnostic method for Medibio’s final depression validation trial
Insight – US to temporarily reduce regulatory barriers for infant formula imports
Immuron partner submits IND application to US FDA for new therapeutic
Product information update for Covid treatment, XEVUDY
Enhertu approved in US for patients with HER2-positive metastatic breast cancer treated with prior anti-HER2-based regimen
New senior appointments for Tessara Therapeutics
Botanix acquires rights to new dermatology product
Imfinzi plus chemotherapy granted Priority Review in US for patients with locally advanced or metastatic biliary tract cancer based on TOPAZ-1 Phase
Ultomiris approved in US for adults with generalised myasthenia gravis
Enhertu granted Breakthrough Therapy Designation in US for patients with HER2-low metastatic breast cancer
Tremelimumab accepted under Priority Review in US for patients with unresectable liver cancer
Enhertu granted Priority Review in US for patients with previously treated HER2-mutant metastatic non-small cell lung cancer
Permanent birth control methods for women have up to 6% failure rates
Victorian Premier’s Awards recognise rising stars
NCI-COG Pediatric MATCH study shows benefit of genetic screening in refractory tumors
Neuren receives FDA approval for Pitt Hopkins IND and Phase 2 trial
Promising nose spray could prevent and treat Covid
BioScience Managers welcomes FDA approval of Saluda technology
Unlocking secrets of neurodegenerative disease drives UQ-industry collaboration
US FDA grants new orphan designation to Noxopharm’s Veyonda
Update on US regulatory review of Fasenra in chronic rhinosinusitis with nasal polyps
Telix’s ZIRCON late-stage kidney cancer imaging study completes enrolment
FDA Clearance of Plasma Collection Technology
Approval for Neuren Pharmaceuticals’ Phase 2 trial in Angelman syndrome
Phebra Receives TGA Authorisation for Manufacture of Critical Care Medicines for TGA Trials
Kazia Therapeutics to be ‘transformed’ by pipeline progress
AGA recommends shared decision-making approach for treatment of hepatocellular carcinoma
International study reveals how drug safety advisories affect prescribing
AllVascular strengthens its Medical Advisory Board as progress accelerates in Europe and US
Existing drug may protect against COVID lung injury
Covid community surveillance project launches
Prescribing of psychiatric drugs to Australian kids on rise
Counterfeit Nitrile Gloves
Enhertu granted Priority Review in US for patients with HER2-positive metastatic breast cancer treated with prior anti-HER2-based
Measuring medicine in livestock supports fight against antimicrobial resistance
Portable prostate cancer test may help reach underserved men
Evusheld long-acting antibody combination retains neutralising activity against Omicron variant 23 December
US FDA approved cabotegravir extended-release – first long-acting injectable option for HIV pre-exposure prophylaxis
Ultomiris regulatory submission accepted under FDA Priority Review
Tezspire approved in US for severe asthma
Positive late-stage trial results for Neuren Pharmaceuticals’ trofinetide
US FDA grants new fast designation for Bionomics’ BNC210
Lynparza granted Priority Review in US for BRCA-mutated HER2-negative high-risk early breast cancer
Hepatitis Drug Increases Antibiotic Potency, Limits Antibiotic Resistance
New analyses of two AZD7442 Covid Phase III trials in high-risk populations confirm robust efficacy and long-term prevention
Cornell recommends booster shots for those eligible
Translating pioneering research into clinic
Identifying keys to preventing cerebral palsy in premature babies