Legend’s Carvykti (ciltacabtagene autoleucel) Receives the EC’s Approval for the Treatment of Relapsed and Refractory Multiple Mye...
Shots: The conditional approval was based on the P-Ib/II (CARTITUDE-1) study evalu...
Servier’s Tibsovo (ivosidenib) Receives the US FDA's Approval for the Treatment of IDH1-mutated Acute Myeloid Leukemia
Shots: The approval was based on the P-III (AGILE) study evaluating Tibovo + azaci...
Ocugen’s NeoCart Receives the US FDA Regenerative Medicine Advanced Therapy Recognition for the Treatment of Knee Injury in Adults
Shots: NeoCart is a P-III cell therapy platform technology, a 3D tissue-engineered...
ImmuntyBio Submits Biologics License Application for N-803 + BCG to Treat BCG-unresponsive NMIBC CIS
Shots: The BLA submission was based on the results from the P-I/II trial (n=171) &...
Merck Receives CHMP Positive Opinion of Keytruda (pembrolizumab) as Adjuvant Treatment for Stage IIB or IIC Melanoma
Shots: The EMA’s CHMP has adopted a positive opinion recommending approval o...
Eli Lilly and Incyte Receive CHMP Positive Opinion of Olumiant (baricitinib) for the Treatment of Adults with Severe Alopecia Area...
Shots: The opinion was based on P-III (BRAVE-AA1 & 2) trials...
