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Approvals

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First-Line Bavencio Bladder Cancer OK Boosts Merck KGaA

Pfizer-partnered Bavencio has struggled to compete with other checkpoint inhibitors like Keytruda, Opdivo, Imfinzi and Tecentriq, but could carve out a lucrative niche in first-line urothelial carcinoma.

Approvals ImmunoOncology

ViiV Anticipates 10%-15% Switchover To Long-Term HIV Option Cabenuva

The company is optimistic about a significant portion of eligible patients opting for its newly approved long-acting HIV therapy over daily, oral antiviral therapy.

Approvals Business Strategies

Pipeline Watch: Phase III Starts In Hypertension, Atopic Dermatitis

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements

Pipeline Watch Approvals

Merck & Co. Pushes Back On Modest Projections For Verquvo

Merck & Co.'s vericiguat, an sGC stimulator, was approved for heart failure but it enters a competitive space with a narrow indication.

Approvals Business Strategies

Pipeline Watch: Phase III Starts In PAH, NSCLC And Seizure Disorders

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

FDA Approval Opens Up Gastric Cancer To Daiichi Sankyo/AZ’s Enhertu

The two companies can now market their HER-2 targeting antibody-drug conjugate in its second tumor type as they look to expand beyond breast cancer.

Approvals United States

COVID-19 Could Change Attitudes To Flu, Bolster Xofluza

Roche’s first-in-class one-dose antiviral Xofluza has been approved for marketing in the EU to treat influenza in patients aged 12 years or over, and for post-exposure prophylaxis.

Infectious Diseases Approvals

Coronavirus Update: Moderna Vaccine Gets UK Go-Ahead As EU Approval of Oxford/AZ Vaccine Due In Weeks

Moderna’s mRNA COVID-19 vaccine has received an approval from the UK’s MHRA, while AstraZeneca is expected to apply for the EU approval of its COVID-19 vaccine next week.

Coronavirus COVID-19 Vaccines

Pipeline Watch: Phase III Readouts in Dry Eye Disease, Amyloidosis And Crohn's Disease

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals
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