The EC Approves Servier’s Voranigo (vorasidenib) for Grade 2 IDH-Mutant Glioma in the EU

Shots: The EC has approved Voranigo for treating patients (age: ≥12yrs.; wt≥ 40kg) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery, but do not currently require radiotherapy or CT across EEA states Approval was based on the global pivotal P-III (INDIGO) trial, which demonstrated that vorasidenib significantly improved PFS and TTNI vs…

ByDipanshu DixitSeptember 19, 2025

INSIGHTS+

EMA Marketing Authorization of New Drugs in August 2025

Shots: The EMA’s CHMP has granted approvals to 1 Biologic and 3 new chemical entities in August 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drug was Gilead’s Yeytuo has Secured the EC’s Approval for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV PharmaShots has compiled a list of 4…

ByDipanshu DixitSeptember 16, 2025

NEWS

Bio-Thera Secures the EC’s Approval for Usymro (Biosimilar, Stelara)

Shots: The EC has approved Usymro (BAT2206), a biosimilar version of J&J’s Stelara (ustekinumab) for all indications of the reference product In Oct 2024, Bio-Thera & Gedeon Richter entered a licensing & commercialization deal under which Bio-Thera will develop & manufacture Usymro, while Gedeon will commercialize it post-approval & MA Holder transfer in the EU,…

ByRidhi RastogiAugust 27, 2025

NEWS

Rhythm Pharmaceuticals Reports the US FDA’s sNDA Acceptance and Priority Review of Setmelanotide to Treat Acquired Hypothalamic Obesity

Shots: The US FDA has accepted sNDA of setmelanotide for the treatment of conditions associated with acquired hypothalamic obesity (PDUFA: Dec 20, 2025); Type II variation MAA is under the CHMP’s review sNDA & MAA were supported by global P-III (TRANSCEND) trial (N=120) assessing setmelanotide (n=81) vs PBO (n= 39) in 49 adults & 71 pediatric…

ByRidhi RastogiAugust 21, 2025

INSIGHTS+

EMA Marketing Authorization of New Drugs in July 2025

Shots: The EMA’s CHMP has granted positive opinions and approvals to 3 Biologics and 10 new chemical entities in July 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drug was Roche’s Itovebi Secures the EC’s Approval for PIK3CA-mutated Breast Cancer PharmaShots has compiled a list of 13 drugs…

ByDipanshu DixitAugust 19, 2025

NEWS

BeOne Medicines’ BGB-16673 Receives the EMA’s PRIME Designation to Treat Waldenstrom’s Macroglobulinemia

Shots: The EMA has granted PRIority MEdicines (PRIME) designation to BGB-16673 for the treatment of pts with Waldenstrom’s macroglobulinemia (WM), who previously were treated with a BTK inhibitor Designation was based on data showing BGB-16673’s novel ability to degrade both wild-type & mutant BTK forms, incl. resistance-linked variants, which demonstrated anti-tumor activity in B-cell malignancies…

ByRidhi RastogiAugust 1, 2025

NEWS

IntraBio’s Aqneursa Receives the CHMP’s Positive Opinion for Treating Niemann-Pick Disease Type C (NPC)

Shots: The CHMP has recommended Aqneursa (levacetylleucine) for treating adults & pediatric pts with NPC; additional global submissions are planned for 2025 & beyond Approval was backed by P-III (IB1001-301) study assessing Aqneursa vs PBO in pts (≥4yrs.; n=60) with NPC, which showed improved neurological symptoms & function across all 1 & 2EPs within 12wks.,…

ByRidhi RastogiJuly 30, 2025

NEWS

Henlius Receives the CHMP’s Positive Opinion for HLX14 (Biosimilar, Prolia/Xgeva)

Shots: Shots: The CHMP has recommended approval of HLX14, a biosimilar version of Amgen’s Prolia/Xgeva (denosumab) for all indications of the reference product; review is ongoing in the US, Canada & other regions Opinion was based on multiple H2H trials, incl. analytical & clinical studies, which showed similar quality, efficacy & safety of HLX14 vs…

ByRidhi RastogiJuly 29, 2025

NEWS

Ionis Reports the CHMP’s Positive Opinion on Tryngolza for Familial Chylomicronemia Syndrome

Shots: The CHMP has recommended Tryngolza (olezarsen) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome; EC’s decision is expected in Q4’25 Opinion was based on P-III (Balance) trial assessing (Q4W) vs PBO, which showed reduced triglyceride levels at 6mos., sustained through 12mos., with decrease in acute…

ByRidhi RastogiJuly 29, 2025

NEWS

Gilead Reports the CHMP’s Positive Opinion on Lenacapavir for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Shots: The CHMP has recommended approval of the MAA & EU-M4all application of lenacapavir as PrEP for individuals at risk of HIV across all 30 EEA states. It will be marketed in the EU as Yeytuo, if approved by the EC by late 2025 Opinion was based on P-III (PURPOSE 1 & PURPOSE 2) trials…

ByRidhi RastogiJuly 28, 2025

The EC Approves Servier’s Voranigo (vorasidenib) for Grade 2 IDH-Mutant Glioma in the EU

EMA Marketing Authorization of New Drugs in August 2025

Bio-Thera Secures the EC’s Approval for Usymro (Biosimilar, Stelara)

Rhythm Pharmaceuticals Reports the US FDA’s sNDA Acceptance and Priority Review of Setmelanotide to Treat Acquired Hypothalamic Obesity

EMA Marketing Authorization of New Drugs in July 2025

BeOne Medicines’ BGB-16673 Receives the EMA’s PRIME Designation to Treat Waldenstrom’s Macroglobulinemia

IntraBio’s Aqneursa Receives the CHMP’s Positive Opinion for Treating Niemann-Pick Disease Type C (NPC)

Henlius Receives the CHMP’s Positive Opinion for HLX14 (Biosimilar, Prolia/Xgeva)

Ionis Reports the CHMP’s Positive Opinion on Tryngolza for Familial Chylomicronemia Syndrome

Gilead Reports the CHMP’s Positive Opinion on Lenacapavir for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

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