Merck announced it got an FDA Complete Response Letter regarding its New Drug Application for gefapixant.

Rallybio Corporation revealed early Phase 1 trial results for RLYB116, a novel drug with prolonged action and subcutaneous administration in low volumes.

Almirall S.A. has recently launched a phase I clinical trial to assess the safety profile, pharmacokinetic properties, immunogenic potential, and pharmacodynamic effects of ALM223.

Tiziana Life Sciences Ltd. has announced the start of a Phase 2a trial, assessing the efficacy and safety of two doses of intranasal foralumab compared to placebo in patients with non-active secondary-progressive multiple sclerosis.

Mabwell announced the NMPA's approval of its IND application for 8MW0511, an innovative injectable recombinant fusion protein drug.

Telix Pharmaceuticals has submitted a BLA to the U.S. FDA for TLX250-CDx (Zircaix™), a PET scan diagnostic agent for clear cell renal cell carcinoma.

Santhera Pharmaceuticals has declared that its drug, AGAMREE® (vamorolone), has received authorization within the European Union to be prescribed for those diagnosed with Duchenne muscular dystrophy.

InnoCare Pharma has announced that their phase II trial of the novel TYK2 inhibitor ICP-332 met its primary endpoint in treating adults with moderate to severe atopic dermatitis.

Caliway Finalizes Funding Round Exceeding Targets, Locks in Excess of $100M for Critical Phase 3 Trial of CBL-514 for Subcutaneous Fat Reduction.

Wave Life Sciences has commenced the Phase 2 FORWARD-53 study, beginning treatment with WVE-N531 for individuals with Duchenne Muscular Dystrophy.

LEO Pharma Inc. has disclosed that the FDA has recently broadened the sanctioned use of Adbry (tralokinumab-ldrm) by authorizing its application for young individuals.

FDA greenlights the unique combination of enfortumab vedotin (PADCEV®) and pembrolizumab (KEYTRUDA®), marking the first coalescence of an ADC and PD-1 inhibitor to combat progressive bladder carcinoma.