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You searched for : CHMP  

European Commission approves Teysuno in metastatic colorectal cancer

Latest Corporate news updates; Pharma Feb 3rd 2022...
Feb 03

Pfizer receives CHMP positive opinion for Novel COVID-19 oral treatment

Latest corporate news update : Pharma Jan 1/2022...
Feb 01

GSK and Vir Biotechnology announce joint procurement agreement with European Commission for COVID-19 treatment, Sotrovimab

Latest pharma news update...
Aug 02

Status on FDA Advisory Committee vote on roxadustat in anaemia of chronic kidney disease

New solutions are needed for the six million people in the US affected by anaemia of chronic kidney disease....
Jul 17

Forxiga recommended for approval in the EU by CHMP for the treatment of patients with chronic kidney disease

If approved, Forxiga has the potential to change the treatment paradigm for millions of people in the EU suffering from chronic kidney disease...
Jun 28

Bristol Myers Squibb Receives Positive CHMP Opinion for Opdivo as Adjuvant Treatment for Esophageal or Gastroesophageal Junction Cancer Patients with Residual Pathologic Disease Following Chemoradiotherapy

Recommendation based on positive results from the Phase 3 CheckMate -577 trial in which Opdivo doubled disease-free survival compared to placebo in the all-...
Jun 25

Bristol Myers Squibb Receives Positive CHMP Opinion for Anti-BCMA CAR T Cell Therapy Abecma for Relapsed and Refractory Multiple Myeloma

...
Jun 25

GSK and Vir Biotechnology starts EMA rolling review of VIR-7831 (sotrovimab) for treatment of COVID-19

GSK's Covid product could be soon in the market after the emergency medical application review...
May 11

Pfizer and BioNTech to supply the European Union with 100 million additional doses of COVID vaccine

COMIRNATY will be produced in BioNTech’s and Pfizer’s manufacturing sites in Europe ...
Apr 20

Xeris Pharmaceuticals receives approval from the European Commission for Ogluo

Ogluo (Glucagon) is indicated treatment of severe hypoglycemia...
Feb 15

AtraZeneca's Imfinzi approved in the EU for less-frequent, fixed-dose use in unresectable non-small cell lung cancer

New option extends dosing from two to four weeks, reducing medical visits and improving patient convenience ...
Jan 15

Imfinzi recommended for approval in the EU by CHMP for non-small cell lung cancer

This new dosing option is consistent with the approved Imfinzi dosing in extensive-stage small cell lung cancer and once approved, will be available to ...
Dec 15

USFDA approves Roche’s OCREVUS shorter 2-hour infusion for relapsing and primary progressive multiple sclerosis

Shorter infusion time will further improve the twice-yearly treatment experience for OCREVUS, the only B-cell therapy for relapsing and primary progressive MS with ...
Dec 15

Biocon Biologics, Mylan get CHMP recommendation for approval of biosimilar insulin Aspart

Biocon subsidiary Mylan advances their ...
Dec 14

Trixeo Aerosphere approved in the EU for maintenance treatment of COPD

COPD is a progressive disease, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness and is the third leading ...
Dec 14

Trastuzumab deruxtecan recommended for approval in the EU by CHMP for HER2-positive metastatic breast cancer

The impact of the disease is significant, with breast cancer responsible for more than 137,000 deaths per year....
Dec 14

CHMP recommends approval of Plavix with aspirin in adults for certain types of strokes

CHMP issues positive opinion for use of Plavix with aspirin in adults within 24 hours of minor ischemic stroke or high-risk transient ischemic attack ...
Dec 12

BAVENCIO receives positive CHMP opinion for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma

This year US FDA has approved BAVENCIO for the maintenance treatment of patients with locally advanced or metastatic UC...
Dec 12

Bristol Myers Squibb Receives Positive CHMP Opinion for Inrebic for Adult Patients with Myelofibrosis

If approved, Inrebic will become the first new therapy for myelofibrosis in Europe in nearly a decade....
Dec 11

ViiV Healthcare announces positive CHMP opinion for Rukobia, for the treatment of adults with multidrug-resistant HIV

Fostemsavir addresses a critical unmet need in HIV care for those with little to no treatment options left....
Dec 11

European CHMP Adopts Positive Opinion for HEPLISAV-B®, Dynavax's Two Dose Adult Hepatitis B Adjuvanted Vaccine

Dynavax Technologies Corporation, today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on ...
Dec 11

Merck Receives Positive EU CHMP Opinion for KEYTRUDA as First-Line Treatment for Metastatic Microsatellite Instability

...
Dec 11

Orchard Therapeutics announces US FDA clearance of IND application for OTL-200 for metachromatic leukodystrophy

The company believes that OTL-200 offers tremendous potential to transform the lives of many young patients with MLD...
Nov 21

ViiV Healthcare announces CHMP positive opinion for the first-ever dispersible-tablet formulation of dolutegravir, Tivicay, a treatment for children living with HIV in Europe

Dolutegravir is the first integrase inhibitor available as a dispersible tablet for children...
Nov 13

European Commission approves Roche’s Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer

European Commission approves Roche’s Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer....
Nov 02

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