The agency approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia.

The ACGcaps H+ capsules work to meet pharmaceutical and nutraceutical needs while remaining gelatin-free.

A GAO report analyzes some of the reasons why so few generics are approved the first time around. NIPTE has proposed a program that would address these issues

FDA has issued a complete response letter to Sarepta Therapeutics for its new drug application seeking approval for a new Duchenne muscular dystrophy drug.

The new treatment achieved primary endpoint of overall response rate (ORR) by investigator review and by the independent review committee (IRC) assessment.

The new drug is meant to be used in combination therapy for treating pediatric patients with pulmonary multidrug-resistant tuberculosis.

The Birtley, UK facility added cleanroom, manufacturing, and testing facilities for biopharma manufacturing single-use systems.

RINVOQ for the treatment of adults with moderately to severely active rheumatoid arthritis has been approved by FDA

Olympus will launch its first Global Image of the Year Life Science Light Microscopy Award to recognize life science imaging.

FDA sent a warning letter to Emcure Pharmaceuticals, Ltd. because of sterility testing CGMP violations.

A strategic agreement has been announced that will see all shares of Cytena be sold to Cellink for a purchase price of EUR30.25 million (US$33.79 million).

ACG Engineering, which is a part of the ACG Group, has announced its acquisition of a German-based pharma processing equipment provider, Xertecs.

Exscientia has revealed that Sanofi will be advancing an innovative bispecific small-molecule project that was discovered through the companies’ modality collaboration.

The latest research from GlobalData has revealed that more than two-thirds (69%) of CMOs high-containment facilities are based in the top five European Union countries and Switzerland.

Nemera has acquired a healthcare focused design and innovation consulting firm in Chicago, IL, Insight Product Development, strengthening its presence in North America.

Industry has responded favorably to the recent announcement from the UK's PM that immigration rules should be developed to ensure scientific talent is attracted to the country.

GNA Biosolutions has completed its latest round of Series C financing in which it raised US$13.5 million.

The European Commission has approved an extension of the use of Dupixent (dupilumab) within the EU to include patients aged 12 to 17 years old with moderate-to-severe atopic dermatitis.

The company is recalling the product because of potential microbiological contamination.

Optima Pharma opened a new assembly hall, the CSPE Center, that will give the company space to build complete, multi-story pharmaceutical manufacturing facilities.

Nephron Pharmaceuticals is partnering with Clemson University to create a robotic solution for syringe-filling automation to enhance sterile manufacturing.

The companies have entered into a manufacturing agreement for the production of Phase III clinical trial material.

The agency is planning to clean out its drug listing records and urges companies to update any inaccurate active drug listing submission.

Spectrum Laboratory Products received an FDA warning letter after violations were found at its New Brunswick, NJ facility.

A New Jersey court upheld the validity of patent claims for Amgen’s anti-inflammatory blockbuster biologic, Enbrel (etanercept).

AskBio’s acquisition of Synpromics will improve the efficacy of its adeno-associated virus gene therapy vectors.

Using Alternating Tangential Flow in a 3000-L perfusion bioreactor, the company expects to reduce production time by up to 30%

The acquisition strengthens BioLife’s position as a supplier of disruptive, enabling solutions used for manufacturing, storage, and distribution of cell and gene therapies.