Blog Band - PharmaShots

05

Shots: The US FDA has accepted NDA of oral Wegovy for chronic weight management & major adverse CV events risk reduction in adults with obesity or overweight & comorbidities (PDUFA:…

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7 hours ago

INSIGHTS+

PharmaShots’ Key Highlights of Third Quarter 2025

Shots: Q3’25 was marked by major pharma and biotech M&A, led by BD’s $17.5B Reverse Morris Trust deal merging its Biosciences & Diagnostic Solutions unit with Waters, and Merck’s ~$10B…

01

8 hours ago

NEWS

AbbVie Reports the US FDA’s BLA Submission of Pivekimab Sunirine to Treat Blastic Plasmacytoid Dendritic Cell Neoplasm

Shots: The US FDA has received BLA of Pivekimab sunirine (PVEK) for the treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) The BLA is backed by the P-I/II (CADENZA) trial,…

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8 hours ago

VIDEO

LIFE SCIENCES | DAILY NEWS | OCT 01, 2025 | PHARMASHOTS

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9 hours ago

NEWS

Abbott Receives Health Canada’s Approval for Esprit BTK System to Treat Chronic Limb Threatening Ischemia Below the Knee

Shots: Abbott has received Health Canada’s approval for the Esprit BTK Everolimus Eluting Resorbable Scaffold System to treat people with chronic limb-threatening ischemia (CLTI) below the knee (BTK) Esprit was…

01

10 hours ago

NEWS

Zoetis’ Dectomax-CA1 Injectable Receives the US FDA’s Conditional Approval to Prevent New World Screwworm Infestations in Cattle

Shots: The US FDA has granted conditional approval to Dectomax-CA1 Injectable for the prevention & treatment of infestations caused by the larvae of Cochliomyia hominivorax (New World Screwworm; myiasis) Dectomax-CA1 Injectable is approved…

01

12 hours ago

NEWS

Pharming Reports the US FDA’s sNDA Acceptance and Priority Review to Leniolisib for Activated Phosphoinositide 3-Kinase Delta Syndrome

Shots: The US FDA has accepted sNDA & granted priority review to leniolisib for the treatment of children (4-11yrs.) with activated phosphoinositide 3-kinase delta (APKD) syndrome (PDUFA: Jan 31, 2026);…

01

13 hours ago

NEWS

Hinge Bio Collaborates with Kyorin Pharmaceutical to Advance HB2198 in Japan for Autoimmune Diseases

Shots: Hinge Bio & Kyorin have entered into a collaboration & license agreement to develop HB2198 in Japan for various autoimmune diseases, starting with systemic lupus erythematosus (SLE), which is expected…

01

14 hours ago

NEWS

Novartis’ Rhapsido (Remibrutinib) Receives the US FDA’s Approval for Chronic Spontaneous Urticaria

Shots: The US FDA has approved Rhapsido for the treatment of adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Regulatory filings are also made in…

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1 day ago

INSIGHTS+

Disease of the Month – Alopecia

Shots: Hair loss (alopecia) is a condition that causes thinning or loss of hair on the scalp or the entire body. It can be temporary or permanent and may result…

30

1 day ago

NEWS

Novo Nordisk Reports the US FDA’s BLA Submission of Mim8 (Denecimig) for Haemophilia A with or without Inhibitors

Shots: The US FDA has accepted the BLA for Mim8 (denecimig; pre-filled, single-use pen) as routine prophylaxis to prevent or reduce bleeding episodes in adult & pediatric pts with hemophilia…

Novo Nordisk Reports the US FDA’s NDA Acceptance of Oral Wegovy for Weight Management

PharmaShots’ Key Highlights of Third Quarter 2025

AbbVie Reports the US FDA’s BLA Submission of Pivekimab Sunirine to Treat Blastic Plasmacytoid Dendritic Cell Neoplasm

LIFE SCIENCES | DAILY NEWS | OCT 01, 2025 | PHARMASHOTS

Abbott Receives Health Canada’s Approval for Esprit BTK System to Treat Chronic Limb Threatening Ischemia Below the Knee

Zoetis’ Dectomax-CA1 Injectable Receives the US FDA’s Conditional Approval to Prevent New World Screwworm Infestations in Cattle

Pharming Reports the US FDA’s sNDA Acceptance and Priority Review to Leniolisib for Activated Phosphoinositide 3-Kinase Delta Syndrome

Hinge Bio Collaborates with Kyorin Pharmaceutical to Advance HB2198 in Japan for Autoimmune Diseases

Novartis’ Rhapsido (Remibrutinib) Receives the US FDA’s Approval for Chronic Spontaneous Urticaria

Disease of the Month – Alopecia

Novo Nordisk Reports the US FDA’s BLA Submission of Mim8 (Denecimig) for Haemophilia A with or without Inhibitors

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