Latest FDA News | Page 5

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
Behrend Speaker Series to feature NASA engineer Moogega ‘Moo’ Cooper
Awareness and Knowledge of PrEP Varies by Rural vs. Urban Setting Among People Who Inject Drugs
Tezepelumab granted Orphan Drug Designation in US for eosinophilic esophagitis
Recreational Ketamine Use Has Increased in Recent Years, But Remains Rare
Enhertu granted Breakthrough Therapy Designation in US for patients with HER2-positive metastatic breast cancer treated with one
AstraZeneca to fully acquire Caelum Biosciences
Pictor and SCIENION partner to commercialise high-throughput SARS-CoV-2 antibody testing system to support ongoing fight against
Use of face masks during MRI examinations
US FDA grants emergency authorisation to Ellume’s COVID-19 test
Europe grants Antisense’s ATL1102 orphan designation
TGA grants priority review for Telix Pharmaceuticals’ TLX591-CDx
Should Australians be worried about waiting for a COVID vaccine?
When there is good vaccine news – efficacy is only beginning of story
Leukaemia researcher Professor Andrew Roberts joint winner of Ramaciotti Medal
Efficacy, politics influence public trust in COVID-19 vaccine
BIG Idea finalists to pitch ideas for $50,000 prize
Laparoscopic power morcellators – Update 3
BioPharma News Wire: Agilex Biolabs Develops World’s Most Accurate Cannabinoid Assay