Crinetics Pharmaceuticals Reports the US FDA’s Approval of Palsonify (Paltusotine) for Acromegaly

Shots: The US FDA has approved Palsonify for 1L treatment of adults with acromegaly who are ineligible for or inadequately respond to surgery; commercially available in the US by Oct 2025 & MAA under EMA's review, with CHMP opinion expected in H1’26 Approval was based on 2 P-III (PATHFNDR-2 & PATHFNDR-1) trials assessing Palsonify vs PBO…

ByRidhi RastogiSeptember 26, 2025

NEWS

Alvotech’s Gobivaz (Biosimilar, Simponi) Receives the CHMP’s Positive Opinion to Treat Several Chronic Inflammatory Diseases

Shots: The CHMP has recommended Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis, PsA, ankylosing spondylitis & ulcerative colitis in adult pts & juvenile idiopathic arthritis across 30 EEA states In trials, Gobivaz demonstrated comparable efficacy, safety, & immunogenicity to Simponi in pts…

ByRidhi RastogiSeptember 24, 2025

NEWS

Alvotech Receives the CHMP’s Positive Opinion for AVT03 (Biosimilar, Prolia & Xgeva)

Shots: The CHMP has recommended AVT03, a biosimilar version of Amgen’s Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disorders STADA & Dr. Reddy’s have semi-exclusive commercial rights to AVT03 in the EU, incl. Switzerland & the UK, leading to STADA marketing it as Kefdensis (Prolia; 60mg/mL PFS) & Zvogra (Xgeva; 70mg/mL single-use…

ByRidhi RastogiSeptember 23, 2025

NEWS

Bayer Reports the CHMP’s Positive Opinion of Elinzanetant to Treat Vasomotor Symptoms

Shots: The CHMP has recommended elinzanetant for treating mod. to sev. vasomotor symptoms linked with menopause or caused by AET related to breast cancer based on P-III (OASIS-1, 2, 3 & 4) trials OASIS-1 & 2 showed reduced mod. to sev. menopausal VMS vs. PBO at wks. 4 & 12, with >80% pts (incl. those…

ByRidhi RastogiSeptember 23, 2025

NEWS

The CHMP Adopts Positive Opinion on Merck’s Enflonsia for RSV Prevention in Infants

Shots: The CHMP has recommended Enflonsia to prevent RSV lower respiratory tract disease in newborns & infants entering their first RSV season, with potential approval valid in all 30 EEA states Opinion was based on P-IIb/III (CLEVER) study assessing Enflonsia in preterm & full-term infants (≤1yr.), plus P-III (SMART) study of Enflonsia vs palivizumab in high-risk…

ByRidhi RastogiSeptember 22, 2025

NEWS

Johnson & Johnson Reports the CHMP’s Positive Opinion of Nipocalimab for Generalized Myasthenia Gravis (gMG)

Shots: The CHMP has recommended Nipocalimab as an add-on therapy to treat anti-AChR Ab+ & anti-MuSK Ab+ gMG pts (≥12yrs.) Opinion was based on the P-III (Vivacity-MG3) trial assessing nipocalimab (30mg/kg, IV loading dose then 15mg/kg, Q2W) + SoC vs PBO + SoC in gMG pts (N=199; 153 were Ab +ve), which showed improved MG-ADL score…

ByRidhi RastogiSeptember 22, 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

Crinetics Pharmaceuticals Reports the US FDA’s Approval of Palsonify (Paltusotine) for Acromegaly

Alvotech’s Gobivaz (Biosimilar, Simponi) Receives the CHMP’s Positive Opinion to Treat Several Chronic Inflammatory Diseases

Alvotech Receives the CHMP’s Positive Opinion for AVT03 (Biosimilar, Prolia & Xgeva)

Bayer Reports the CHMP’s Positive Opinion of Elinzanetant to Treat Vasomotor Symptoms

The CHMP Adopts Positive Opinion on Merck’s Enflonsia for RSV Prevention in Infants

Johnson & Johnson Reports the CHMP’s Positive Opinion of Nipocalimab for Generalized Myasthenia Gravis (gMG)

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

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