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Hospira is voluntarily recalling more than 24,000 syringes of the injectable Amidate because out-of-specification results for degraded product were confirmed during stability testing. Read More
The FDA will not be forced into a shutdown this year after the Senate passed a two-year budget early Friday morning for fiscal years 2016 and 2017. Read More
To defuse a growing scandal, Valeant Pharmaceuticals has cut ties with a mail-order pharmacy accused of pushing expensive drugs on pharmaceutical buyers. Read More
Gilead Submits NDA for Combo Drug That Treats All Genotypes of Hep C FDA AdComm Cancels Review of Repos’ Testosterone Replacement Candidate Pfizer and Allergan in Merger Talks Ultragenyx, Arcturus Partner to Develop mRNA Therapeutics to Rare Disease Targets
Pfizer Recruits GSK to Build Manufacturing Prototype Sanofi Recalls Auvi-Q Due to Potentially Inaccurate Dosage Delivery Read More
In a draft guidance Thursday, the FDA cautions that liposome drug products may respond to chemistry, manufacturing and control (CMC) changes with greater unpredictability than more conventional formulations. Read More
The FDA is once again giving retail and health system pharmacies that act as dispensers four months to ensure that product tracing information required by track-and-trace regulations is captured and maintained. Read More
The FTC is telling the FDA that its proposal to add four-letter suffixes to nonproprietary names for biosimilars and other biological products could be bad for business. Read More
Warner Chilcott has agreed to pay $125 million to settle charges that it paid kickbacks to physicians to induce them to prescribe seven drugs, and the company’s former president was charged with conspiring to pay the kickbacks, the Department of Justice announced Thursday. Read More
FDA Expands Approval for BMS’ Yervoy to Treat Melanoma FDA Panel Recommends Adding One Substance to the Compounding Bulk Ingredients List CDER Outlines Process for Gathering Network of Experts UK Early Access to Medicine Report Highlights Strategies to Spark Drug Innovation Read More