Genentech Gains FDA Priority Review for Enspryng in MOGAD
SOUTH SAN FRANCISCO, Calif. — September 9, 2026 Genentech, a member of the Roche Group, announced that the U.S....
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Roche Wins FDA Priority Review for Enspryng in MOGAD
BASEL, Switzerland — September 10, 2026 Roche announced that the U.S. Food and Drug Administration (FDA) granted Priority Review...
Merck FDA Accepts ENFLONSIA sBLA for Second RSV Season
RAHWAY, N.J., August 6, 2026 Merck announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental...
Otsuka Advances VOYXACT with Landmark Two-Year Phase 3 IgAN Results
TOKYO, Japan, August 4, 2026 Otsuka Pharmaceutical Co., Ltd. and Otsuka Pharmaceutical Development & Commercialization, Inc. announced new two-year...
Allergan Aesthetics Secures FDA Review for BOTOX Cosmetic
Irvine, California, August 4, 2026 Allergan Aesthetics, an AbbVie company, has announced that the U.S. Food and Drug Administration...
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Genentech Wins FDA Priority Review for Gazyva in pMN
SOUTH SAN FRANCISCO, Calif., July 14, 2026 Genentech, a member of the Roche Group, has received U.S. Food and...
Otsuka Advances VOYXACT Toward Traditional FDA Approval with Phase 3 Success
PRINCETON, N.J. and TOKYO, Japan, July 1, 2026 Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd....
Genentech Wins FDA Priority Review for Enspryng in Thyroid Eye Disease
SOUTH SAN FRANCISCO, Calif., June 29, 2026 Genentech, a member of the Roche Group, announced that the U.S. Food...
Alexion’s Ultomiris Gets FDA Priority Review for IgAN
BOSTON, US | June 15, 2026 Alexion, AstraZeneca Rare Disease announced that the U.S. Food and Drug Administration (FDA)...
Roche Secures FDA sBLA Acceptance for Lunsumio VELO Combination
BASEL, Switzerland, June 18, 2026 Roche announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental...
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