Omeros, MannKind-United Therapeutics, and Revance Therapeutics were issued Complete Response Letters from the U.S. Food and Drug Administration.
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Two years after spinning out from Japan’s Takeda, Phathom Pharmaceuticals is primed to take the company’s acid blocker to the U.S. market with another successful trial.
Valneva SE on Oct. 18 said the company’s experimental Covid-19 vaccine demonstrated efficacy “at least as good, if not better” than AstraZeneca’s shot in a late-stage trial comparing the two, with significantly fewer adverse side effects.
Oyster Point Pharma Inc.’s treatment for dry eye disease became the first U.S. approved nasal spray for the chronic condition on Oct. 18, sending the drug developer’s shares higher.
A late-stage trial of Biogen Inc.’s experimental treatment for an inherited form of amyotrophic lateral sclerosis (ALS) failed to reach the study’s main goal, but secondary measures and biomarkers showed favorable trends, the company said on Oct. 17.
The Greater Than One (GTO) Group announced the introduction of a new operating model to better serve clients outside the United States. Referred to as OUS (Outside United States) On-Demand, the new model will bring the same level of service innovation and value creation abroad as US-based clients experience today.
Outside advisers to the U.S. Food and Drug Administration on Oct. 15 unanimously recommended the regulatory agency authorize a second shot of Johnson & Johnson’s Covid-19 vaccine for all recipients of the one-dose inoculation.
The FDA’s outside expert panel will meet on November 30, 2021, to deliberate Merck’s pill for Covid-19 infection.
Facing thousands of lawsuits related to Johnson & Johnson’s talc-based products, the life sciences giant is launching a separate subsidiary dubbed LTL Management LLC that will take the brunt of potential legal liabilities.
The U.S. Food and Drug Administration agreed to place Regeneron Pharmaceuticals Inc.’s Biologics License Application (BLA) for the Covid-19 drug REGEN-COV under priority review with a target action date of April 13, 2022.