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FDA Advisory Committee votes in favour of the clinical benefit of Roche’s Polivy combination for people with previously untreated diffuse large B-cell lymphoma

U.S. FDA’s Oncologic Drugs Advisory Committee voted 11 to 2 in favour of the clinical benefit of the phase III POLARIX study of Polivy in combination with R-CHP for people with previously untreated ...
Morningstar

Genentech Provides Update on FDA Advisory Committee Meeting on Columvi Combination for People With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Genentech Provides Update on FDA Advisory Committee Meeting on Columvi Combination for People With Relapsed or Refractory Diffuse Large B-cell Lymphoma - Columvi is the first bispecific antibody to ...
FiercePharma

FDA advisors spurn GSK's Blenrep comeback dreams on safety, trial concerns

On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. market, GSK has suffered a serious setback at the hands of the FDA’s Oncologic Drugs Advisory Committee (ODAC) ...
FiercePharma

FDA Advisory Committee Recommends Against Approval of Actavis' Nebivolol/Valsartan Fixed-Dose Combination NDA for Treatment of Hypertension

DUBLIN, Sept. 9, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted to ...
India TV

'No therapeutic justification': Centre bans 14 fixed dose combination drugs as they may pose 'risk' to people

There is "no therapeutic justification" for 14 fixed dose combination medications, including Nimesulide and Paracetamol dispersible tablets and Chlopheniramine Maleate and Codeine syrup, which the ...
Seeking Alpha

Auddia Announces Leadership Changes and Special Committee to Evaluate Business Combination and Restructuring as AI Native Holding Company

New independent board members with experience in AI infrastructure and the evaluation of entrepreneurial ventures added to form a special committee Special committee to evaluate merits of ...
Healio

FDA advisory committee recommends approval of combination weight-loss drug

Please provide your email address to receive an email when new articles are posted on . The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 13-7 for approval of the novel combination ...
Business Wire

FDA Advisory Committee Votes in Favor of the Clinical Benefit of Genentech's Polivy Combination for People With Previously Untreated Diffuse Large B-Cell Lymphoma

“Today’s committee decision to recognize the potential of this Polivy combination as a first-line treatment option is important since four in 10 people with diffuse large B-cell lymphoma relapse or do ...
PharmiWeb

FDA Advisory Committee Votes in Favor of the Clinical Benefit of Genentech's Polivy Combination for People With Previously Untreated Diffuse Large B-Cell Lymphoma

– U.S. FDA’s Oncologic Drugs Advisory Committee voted 11 to 2 in favor of the clinical benefit of the Phase III POLARIX study of Polivy in combination with R-CHP for people with previously untreated ...