FDA

Key Takeaways •The U.S. Food and Drug Administration (FDA) has granted Priority Review to Boehringer Ingelheim’s new drug application for zongertinib (BI 1810631) as a...

Key TakeawaysCtexli represents the first approved treatment specifically targeting CTX Patients must undergo regular liver function tests due to potential liver toxicity The...

Key TakeawaysMerilog's approval is expected to reduce insulin costs due to increased market competition. Patients may experience improved access to insulin therapy with...

Key TakeawaysThe FDA has approved Axsome Therapeutics' SYMBRAVO for acute migraine treatment. SYMBRAVO provides rapid and sustained relief, reducing the need for rescue...

Key TakeawaysThe European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Opdivo (nivolumab) combined with Yervoy (ipilimumab)...

Key TakeawaysRepair Biotechnologies completes a positive Pre-IND meeting with the FDA for REP-0003 mRNA therapy. REP-0003 targets homozygous familial hypercholesterolemia (HoFH), a rare...

Key TakeawaysThe FDA has placed a clinical hold on Atara Biotherapeutics’ trials for EBVALLO™ (tabelecleucel) and ATA3219 due to unresolved GMP compliance issues...

Key TakeawaysThe FDA has issued a Complete Response Letter (CRL) to Atara Biotherapeutics concerning EBVALLO™ (tabelecleucel), citing issues at a third-party manufacturing facility. ...

Key TakeawaysThe FDA clearance enables Ariceum Therapeutics to commence Phase I/II trials for 225Ac-SSO110. The trial will focus on treating small cell lung...

Key TakeawaysThe FDA approval of JYLAMVO now includes paediatric indications for ALL and pJIA. JYLAMVO offers a patient-friendly, orange-flavored oral liquid solution. The...

Key TakeawaysVGA039, Star Therapeutics' investigational monoclonal antibody, receives Fast Track designation for von Willebrand disease (VWD). VGA039 is potentially the first subcutaneous therapy...

Key TakeawaysFDA grants tentative approval for Lasix ONYU, a combination of furosemide and an innovative on-body delivery device. Gerresheimer developed the device with...

Key TakeawaysTRYNGOLZA™ (olezarsen) becomes the first FDA-approved treatment for familial chylomicronemia syndrome (FCS). Demonstrated significant triglyceride reduction and decreased acute pancreatitis events in...

Key TakeawaysInogen’s FDA clearance positions the company competitively within the respiratory care market. The SIMEOX 200’s innovative technology addresses specific needs of patients...

Key TakeawaysOpdivo Qvantig offers faster subcutaneous administration compared to intravenous treatments. Phase 3 trials confirmed efficacy and comparable safety to IV Opdivo. This...