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NEWS

Johnson & Johnson Receives the US FDA’s Approval for Darzalex FASPRO Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: The US FDA has approved Darzalex FASPRO (daratumumab and hyaluronidase-fihj) + bortezomib, lenalidomide & dexamethasone (D-VRd) for adults with NDMM who are ineligible for autologous stem cell transplant. Approval was based on the P-III (CEPHEUS) trial, assessing D-VRd vs VRd in 395 ASCT-ineligible or deferred patients across 13 countries in the EU, North America,…
January 28, 2026

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NEWS

MS Pharma enters an exclusive biosimilar partnership with Hetero 

Shots:  MS Pharma has signed a strategic partnership with Hetero to localize five established biosimilars across key areas, including oncology, immunology, and hematology, in the MENA region  The exclusive agreement will be implemented through El Kendi (MS Pharma Group’s Algeria affiliate) and Hetero Biopharma, a subsidiary of Hetero Group  This marks Hetero’s first local partnership in Algeria, supporting…
January 26, 2026

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NEWS

J&J Reports P-III Trial Outcomes Showing Tecvayli Monotherapy Extends PFS and OS in R/R Multiple Myeloma

Shots: J&J has reported positive topline Phase III (MajesTEC-9) results demonstrating that Tecvayli (teclistamab) monotx. significantly outperformed SoC in r/r multiple myeloma The study included patients with 1–3 prior therapies, all previously treated with anti-CD38 antibodies and lenalidomide. Most patients were refractory to anti-CD38 mAbs (85%), lenalidomide (79%), and their last therapy (>90%). Tecvayli achieved…
January 15, 2026

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CuraTeQ
NEWS

CuraTeQ Biologics Reports the Health Canada’s NOC for Dyrupeg (Biosimilar, Neulasta) 

Shots:  CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, has received NOC from the BRDD for Dyrupeg, a biosimilar to Neulasta (pegfilgrastim)  Dyrupeg (pegfilgrastim) is a long-acting form of filgrastim that mimics human G-CSF, stimulating bone marrow to increase white blood cell production and treat neutropenia  In 2025, Dyrupeg received marketing authorization from the EC and the UK MHRA, with three additional CuraTeQ biosimilar…
January 9, 2026

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INSIGHTS+

2025 Drug Approvals Outlook: A Year of Precision Across Therapeutic Frontiers 

Shots: Precision, convenience, and disease modification define 2025 drug approvals as regulators reward biologically clear, patient-specific therapies that fragment legacy markets, elevate rare diseases, and prioritize meaningful outcomes over broad labels. Innovation is shifting from complexity to usability with oral, subcutaneous, topical, and on-demand therapies improving access and adherence across neurology, cardiology, endocrinology, ophthalmology, and…
January 6, 2026

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VIEWPOINTS

Regeneron at ASH’24: Aafia Chaudhry in a Stimulating Dialogue Exchange with PharmaShots 

Shots:   Recently, Regeneron presented Odronextamab’s data in treating patients with different B-NHL subtypes (OLYMPIA studies) and marginal zone lymphoma (ELM-2 study)  Aafia Chaudhry, Vice President, Global Program Head for Hematology-Oncology at Regeneron, discusses Odronextamab’s ongoing studies as monotherapy and in combination to treat various malignancies  Aafia shares the upcoming PDUFA date on July 30th for…
July 2, 2025

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Enhancing Hematologic Care: Lorah Perlee from Regeneron in a Riveting Dialogue Exchange with PharmaShots
VIEWPOINTS

Enhancing Hematologic Care: Lorah Perlee from Regeneron in a Riveting Dialogue Exchange with PharmaShots

Shots:  At ASH 2024, Regeneron shared data from the P-III exploratory cohort investigating the pozelimab and cemdisiran combination (poze-cemdi) in patients with paroxysmal nocturnal hemoglobinuria  The novel combination (poze-cemdi) achieved meaningful control of intravascular hemolysis compared to ravulizumab   PharmaShots welcomes Lorah Perlee, Vice President, Global Program Head, Hematology and Translational Sciences at Regeneron, for an…
June 23, 2025

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Takeda at ASH 2024: Phuong Khanh Morrow from Takeda in a Riveting Conversation with PharmaShots
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Takeda at ASH 2024: Phuong Khanh Morrow from Takeda in a Riveting Conversation with PharmaShots

Shots:  Recently, at ASH 2024, Takeda presented data from several ongoing clinical trials across hematology and oncology, including the Phase II OPTIC and Phase III PhALLCON studies, among others  Phuong Khanh Morrow, Head of the Oncology Therapeutic Area Unit at Takeda, shed light on Takeda’s key presentations at ASH 2024  Phuong also highlighted the findings…
June 2, 2025

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A Complete Account of EMA Approvals in 2024
INSIGHTS+

A Complete Account of EMA Approvals in 2024

Shots:   In 2024, EMA approved around 53 drugs in various therapy areas, ranging from cardiology, oncology, hematology, neurology, and dermatology to infectious diseases, vaccines, diagnostic agents, pneumology, nephrology, hepatology, ophthalmology, and endocrinology   PharmaShots, in an illuminating report, brings a condensed analysis of the approved drugs with the most explored areas being Oncology, Hematology, Neurology, &…
March 6, 2025

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A Complete Account of FDA Approvals in 2024
INSIGHTS+

A Complete Account of FDA Approvals in 2024

Shots: In 2024, around 50 new drugs were approved by the US FDA across several indications PharmaShots, in an enlightening report, brings a summarized analysis of the approved drugs. The most explored section remains Oncology, Hematology, Dermatology, and Cardiology For the complete report with analysis, reach out to us at  connect@pharmashots.com   While you embraced the new…
February 5, 2025

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