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Neurotech Pharma
NEWS

Neurotech Pharmaceuticals Reports the US FDA Approval for Encelto to treat Macular Telangiectasia Type 2

Shots: The US FDA has approved Encelto (revakinagene taroretcel-lwey) to treat macular telangiectasia type 2 (MacTel); commercially available in the US by Jun 2025 Approval was based on P-III trial data demonstrating reduced macular photoreceptor loss for ~24mos. post-implantation Encelto (intravitreal implant) utilizes an encapsulated cell therapy tech to continuously deliver ciliary neurotrophic…
March 7, 2025

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ARS Pharma
NEWS

ARS Pharmaceuticals’ neffy 1mg Secures the US FDA’s Approval to Treat Type I Allergic Reactions in Children

Shots: The US FDA has approved neffy 1mg (epinephrine nasal spray) to treat type I allergic reactions (incl. anaphylaxis) in children [≥4yrs. & 15-30kg (33-66lbs)]; commercially available in the US by end of May’25 Approval was based on extensive clinical data with PK/PD results comparable to approved epinephrine injections in both pediatric & adult…
March 6, 2025

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Bioheng Therapeutics
NEWS

Bioheng Therapeutics Secures the FDA Clearance of IND Application for CTD402 in T-ALL/LBL

Shots: The US FDA approved Bioheng’s IND application for CTD402 to treat pediatric and adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) CTD402 will be evaluated in a P-Ib/II single-arm, open-label, dose-finding study to optimize dosing and accelerate clinical development CTD402 is a CD7-targeted universal CAR-T (UCAR-T) cell therapy that is genetically…
March 5, 2025

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GSK
NEWS

The US FDA Accepts GSK’s Depemokimab Review Application for Asthma with Type 2 Inflammation and Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Shots: The FDA has accepted review application for BLA of depemokimab as an add-on maintenance therapy for inadequately controlled asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as CRSwNP (PDUFA: Dec 16, 2025), based on P-III (SWIFT & ANCHOR) trials, respectively SWIFT-1 (n=382) & SWIFT-2 (n=380) studies assessed…
March 4, 2025

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Johnson & Johnson
NEWS

Johnson & Johnson’s Darzalex (daratumumab) Receives the CHMP’s Positive Opinion for Multiple Myeloma

Shots: The CHMP has recommended Darzalex (SC) + bortezomib, lenalidomide & dexamethasone (D-VRd) to treat newly diagnosed multiple myeloma pts. Opinion was based on P-III (CEPHEUS) trial, which assessed efficacy & safety in transplant-ineligible or deferred NDMM pts (n=395) not planned for ASCT as initial therapy, in 13 countries across North America, South America and…
March 4, 2025

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Regeneron
NEWS

The CHMP Recommends Conditional Approval of Regeneron’s Linvoseltamab to Treat R/R Multiple Myeloma (MM)

Shots: The CHMP has recommended conditional approval of linvoseltamab for r/r MM pts who had ≥3 prior therapies (incl. proteasome inhibitor, immunomodulator, & anti-CD38 mAb) & had disease progression on last therapy, following the US FDA’s BLA acceptance (PDUFA: Jul 10, 2025) Opinion was based on P-I/II (LINKER-MM1) trial data assessing linvoseltamab (200mg; QW then…
March 3, 2025

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Krystal Biotech
NEWS

Krystal Biotech’s Vyjuvek (beremagene geperpavec) Receives the CHMP’s Positive Opinion for Dystrophic Epidermolysis Bullosa (DEB)

Shots: The CHMP has recommended Vyjuvek (B-VEC) for treating wounds in DEB pts with COL7A1 mutations from birth. The EC's decision is expected in Q2’25, with launch anticipated under the trade name Vyjuvek in 30 EEA states—Germany in mid-2025 & France in late 2025 Opinion was based on various clinical data, incl. P-I/II (GEM-1)…
March 3, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (February 24, 2025 – February 28, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & DigiHealth. Check out our full report below:    Estrella Immunopharma Reports the Approval to Start a Higher Dose Cohort After the Completion of First Dose Cohort in STARLIGHT-1 Study  Read More: Estrella Immunopharma  Regeneron Presents P-I/II (CHORD) Trial Data…
February 28, 2025

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