Angelini Pharma to Acquire Catalyst Pharmaceuticals for ~$4.1B

Shots: Angelini Pharma has entered into a definitive agreement to acquire all outstanding shares of Catalyst, marking Angelini’s entry into the US market As per the deal, Angelini will acquire Catalyst for $31.5 per share in cash, for a total equity value of ~$4.1B; closing is expected in Q3’26 The acquisition will strengthen Angelini’s Brain Health…

ByRidhi RastogiMay 7, 2026

NEWS

X4 Pharmaceuticals’ Xolremdi Receives the EC’s Approval for WHIM Syndrome

Shots: The EC has approved Xolremdi (Mavorixafor), under exceptional circumstances, for the treatment of WHIM syndrome Approval was supported by the global pivotal P-III (4WHIM) trial, PBO-controlled 52-wk study evaluating mavorixafor’s efficacy & safety in pts ≥12 yrs with WHIM syndrome Xolremdi (PO, QD), a CXCR4 antagonist, is used in pts ≥12 yrs with WHIM syndrome to increase circulating mature neutrophils & lymphocytes Ref: X4…

ByDipanshu DixitApril 27, 2026

NEWS

Crinetics Pharmaceuticals Report the EC Approval of Palsonify for Acromegaly

Shots: The EC has approved Palsonify (paltusotine) for treating adults with acromegaly who are ineligible for or inadequately respond to surgery across all 30 EEA states EC approval was supported by P-III PATHFNDR-1 & PATHFNDR-2 trials evaluating Palsonify in previously treated & medically untreated adults with acromegaly, demonstrating rapid onset, reliable biochemical control & sustained efficacy; it also received ODD in EU Crinetics plans…

ByDipanshu DixitApril 23, 2026

NEWS

Novo Nordisk Reports Positive P-III (HIBISCUS) Study Data for Etavopivat in Sickle Cell Disease

Shots: Novo Nordisk reported that etavopivat met both co-1EPs in the P-III (HIBISCUS) study, reducing vaso-occlusive crises (VOCs) and improving haemoglobin response in sickle cell disease The study (n=385, ≥12yrs) evaluated Etavopivat (400mg) vs PBO demonstarting reduced VOCs rates by 27% and delayed time to first VOC (~38.4 vs 20.9 weeks), while 48.7% of patients…

ByPrince GiriApril 20, 2026

NEWS

Sobi Reports Health Canada Approval of Empaveli for C3G and Primary IC-MPGN

Shots: Health Canada has approved Empaveli (pegcetacoplan) for patients (≥12yrs.) with C3 glomerulopathy (C3G) or primary IC-MPGN to reduce proteinuria, marking the first approved therapy for these indications in Canada Approval was based on the P-III (VALIANT) study, where Empaveli demonstrated a 68% reduction in proteinuria (uPCR), stabilization of kidney function, and clearance of C3…

ByPrince GiriApril 10, 2026

NEWS

Sanofi Reports the EC Approval of Rezurock (Belumosudil) to Treat Chronic Graft-vs-Host Disease (GVHD)

Shots: The EC has approved Rezurock (200mg) to treat chronic GVHD pts (≥12yrs., ≥40kg) Approval was based on safety and efficacy clinical data, incl. the P-II (ROCKstar) trial (n=77), which showed an improved ORR of 74% in chronic GVHD pts post–stem cell transplant & after ≥2 prior systemic therapies Under the conditional marketing authorisation, Sanofi will conduct a confirmatory randomized study Ref:…

ByDipanshu DixitMarch 26, 2026

NEWS

UCB Reports the EC Approval of Kygevvi for Thymidine Kinase 2 Deficiency (TK2d)

Shots: The EC has approved kygevvi (doxecitine and doxribtimine) under exceptional circumstances for adults & pediatric pts with TK2d whose symptom onset occurred ≤12yrs. of age Supportive evidence for approval came from pooled data from 2 studies of Kygevvi in pts with genetically confirmed TK2d & symptom onset ≤12yrs. The studies showed improved functional outcomes & survival vs matched external controls after long-term treatment (>5yrs.) …

ByDipanshu DixitMarch 26, 2026

INSIGHTS+

The US FDA New Drug Approvals in February 2026

Shots: Approval momentum strengthened in February 2026, with the US FDA clearing four new therapies across dermatology, psychiatry, and rare pediatric disorders highlighting both volume and therapeutic impact. Four notable therapies crossed the regulatory finish line, Acrotech Biopharma and Otsuka Pharmaceutical’s Adquey for mild-to-moderate atopic dermatitis, Vanda Pharmaceuticals’ Bysanti for acute bipolar I disorder and schizophrenia, Immedica Pharma’s Loargys for ARG1-D–related hyperargininemia, and Ascendis Pharma’s Yuviwel to improve growth in children with achondroplasia Overall, February 2026 reflected…

ByDipanshu DixitMarch 10, 2026

NEWS

NexEos Bio Receives US FDA IND Clearance to Advance NTX-1024 into P-II/III Study for Vernal Keratoconjunctivitis

Shots: The US FDA has cleared NexEos Bio’s IND application to initiate a P-II/III clinical study of NTX-1024 ophthalmic solution for the treatment of vernal keratoconjunctivitis (VKC) The P-II/III study will evaluate the safety and efficacy of NTX-1024 in VKC, following positive results from an open-label investigator-initiated study showing improvements in symptoms and ocular inflammation…

ByDipanshu DixitFebruary 20, 2026

NEWS

Santhera Pharmaceuticals Reports Swissmedic’s Approval of Agamree (Vamorolone) to Treat Duchenne Muscular Dystrophy

Shots: Swissmedic has approved Agamree for the treatment of pts (≥4yrs) with Duchenne muscular dystrophy and expects launch in H2’26 Approval was based on pivotal P-IIb (VISION-DMD) data and EMA assessments, granting 15-year Swiss orphan drug exclusivity; Santhera retains exclusive Swiss distribution. Trial met its 1EP of Time to Stand (TTSTAND) velocity vs PBO at…

ByDipanshu DixitJanuary 15, 2026

Angelini Pharma to Acquire Catalyst Pharmaceuticals for ~$4.1B

X4 Pharmaceuticals’ Xolremdi Receives the EC’s Approval for WHIM Syndrome

Crinetics Pharmaceuticals Report the EC Approval of Palsonify for Acromegaly

Novo Nordisk Reports Positive P-III (HIBISCUS) Study Data for Etavopivat in Sickle Cell Disease

Sobi Reports Health Canada Approval of Empaveli for C3G and Primary IC-MPGN

Sanofi Reports the EC Approval of Rezurock (Belumosudil) to Treat Chronic Graft-vs-Host Disease (GVHD)

UCB Reports the EC Approval of Kygevvi for Thymidine Kinase 2 Deficiency (TK2d)

The US FDA New Drug Approvals in February 2026

NexEos Bio Receives US FDA IND Clearance to Advance NTX-1024 into P-II/III Study for Vernal Keratoconjunctivitis

Santhera Pharmaceuticals Reports Swissmedic’s Approval of Agamree (Vamorolone) to Treat Duchenne Muscular Dystrophy

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