AstraZeneca’s Imfinzi® Receives Positive CHMP Recommendation for Limited-Stage Small Cell Lung Cancer Treatment in the EU

AstraZeneca’s Imfinzi (durvalumab) has been recommended for approval in the European Union (EU) as monotherapy for the treatment of adults ...

February 05, 2025 | Wednesday | News
Vanda Pharmaceuticals and AnaptysBio Enter Exclusive Global License Agreement for Imsidolimab in GPP Treatment

Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) and AnaptysBio, Inc. (Anaptys) (Nasdaq: ANAB) announced an exclusive, global license agreement ...

February 04, 2025 | Tuesday | News
Eisai and Biogen Provide Update on Lecanemab’s EU Regulatory Review for Early Alzheimer’s Disease

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusett...

February 04, 2025 | Tuesday | News
EMA's CHMP Recommends Opdivo® + Yervoy® for First-Line Treatment of Unresectable or Advanced Hepatocellular Carcinoma

 Bristol Myers Squibb (NYSE: BMY) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...

February 03, 2025 | Monday | News
European Commission Approves Vocabria + Rekambys for HIV Treatment in Adolescents Aged 12 and Older

GSK plc (LSE/NYSE: GSK) announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, ...

February 03, 2025 | Monday | News
Merck's CAPVAXIVE™ Pneumococcal Vaccine Receives Positive CHMP Recommendation for Approval in the European Union

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced  that the Committee for Medicinal Products for Human Use (CHMP) of ...

February 03, 2025 | Monday | News
Kazia Therapeutics Launches Groundbreaking Clinical Trial Combining Paxalisib and Immunotherapy for Advanced Breast Cancer

Kazia Therapeutics Limited (NASDAQ: KZIA) an oncology-focused drug development company, is pleased to announce the regulatory approval and launch...

January 31, 2025 | Friday | News
Amgen Announces European Commission Approval of BLINCYTO® for Frontline Treatment of B-ALL

Amgen (NASDAQ:AMGN) announced that the European Commission (EC) has approved BLINCYTO® (blinatumomab) monotherapy as part of consolidation therapy...

January 31, 2025 | Friday | News
Advanced Aesthetic Technologies Receives Approval for Algeness® Dermal Filler in China

Advanced Aesthetic Technologies, Inc. ("AAT") announced  that their partner in China has obtained approval to market their unique dermal fil...

January 29, 2025 | Wednesday | News
GSK's Depemokimab Accepted for EMA Review in Asthma and Chronic Rhinosinusitis with Nasal Polyps

GSK plc (LSE/NYSE: GSK) announced that the European Medicines Agency has accepted for review the Marketing Authorisation Application for the use of depemok...

January 29, 2025 | Wednesday | News
European Commission Approves LAZCLUZE® (lazertinib) and RYBREVANT® (amivantamab) for First-Line Treatment of EGFR-Mutant Advanced NSCLC

Janssen-Cilag International NV, a Johnson & Johnson company, announced that the European Commission (EC) has granted marketing authorization (MA) to LA...

January 28, 2025 | Tuesday | News
Merck’s WELIREG® (belzutifan) Accepted for Priority Review by FDA for Advanced Pheochromocytoma and Paraganglioma

 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) has accepted for prior...

January 28, 2025 | Tuesday | News
Norgine and X4 Pharmaceuticals Celebrate EMA Validation of Mavorixafor for WHIM Syndrome

Following the licensing agreement with X4 Pharmaceuticals, Norgine is pleased to see the announcement from X4 that their Marketing Authorization Applicatio...

January 27, 2025 | Monday | News
Biogen’s LEQEMBI® Gains FDA Approval for Once Every Four Weeks Maintenance Dosing in Alzheimer’s Disease

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusett...

January 27, 2025 | Monday | News

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