FDA issued a warning letter to the company for quality control violations.

The agency sent a warning letter to Cape Apothecary for adulterated drugs.

The company will be investing $3.5 million in a 15,00-square-foot facility in Greenville, North Carolina.

CPhI Worldwide’s Pre-Connect Congress will discuss current trends in the pharmaceutical industry.

The initiative targets countries with less developed and evolving healthcare systems such as Latin America, South East Asia, and Africa.

Recipharm is investing EUR3.7 million (approximately $4.18 million) to increase lyophilization capacity at its Masate facility in Italy.

Ranking members of the Senate Judiciary Committee called on Mylan to explain its decision to raise the price of EpiPens nearly 400%.

ACG APL is the first Asian company to receive this certification.

The portfolio in this agreement include approved antibiotics Merrem, Zinforo, and Zavicefta, as well as candidates in clinical development, ATM-AVI and CXL.

Steep price increases for a popular drug have created patient and Congressional backlash.

A recent paper outlines a methodology to help development teams decide whether switching from batch to continuous mode makes financial and technical sense.

Pfizer will acquire Medivation for approximately $14 billion.

The legal battle between the Broad institute and UC Berkeley heated up after an email was released from a former graduate student.

The joint venture, created through a collaboration with Bayer and CRISPR Therapeutics, will be based in Cambridge, MA.

The company is opening two offices in the United States that will offer serialization, automation, and process control services.

The company is voluntarily recalling one lot of Oxacillin for Injection, USP, 10 g.

CDMO Alcami adds HPAPI capacity and cryogenic capabilities to its Wisconsin facility.

Fresenius Kabi will add to its generic, sterile injectable manufacturing at its Melrose Park, Illinois site.

Arbor Pharmaceuticals is voluntarily recalling Cetylev (acetylcysteine) effervescent tablets due to inadequate seal of the blister pack.

TOPAS Advanced Polymers announces its COC materials are compliant with new USP standard for pharma plastic packaging systems.

The design of Baxter BioPharma Solutions’ aseptic filling lines provides a case study in customizing containment systems for multi-product lines

The Chinese facility was cited for data integrity violations.

The Group is focusing on standardizing data exchanges between the enterprise serialization management function and product packaging lines.

Nine public health organizations submitted a letter to US House and Senate committees citing concerns about Section 11 of the FDA and NIH Workforce Authorities Modernization Act.

The bio-incubator, located at the James Cook University Hospital, will give early-stage biotechnology and life-sciences companies access to facilities to support biomedical research.

Flawed testing and analysis and a failure to analyze the root cause of customer complaints were among the top problems noted in FDA's letter to the Florida-based transdermal drug manufacturer.

The agency publishes guidance on the appropriate classification of co-crystal solid-state forms.

The company received breakthrough therapy designation for esketamine, a treatment for major depressive disorder with imminent risk for suicide.