FDA

The FDA has refused to review Theratechnologies’ supplemental Biologics License Application, seeking approval for an intramuscular formulation for the maintenance dose of its HIV therapy Trogarzo (ibalizumab-uiyk), the biotech announced on Tuesday.

FDA

The FDA is planning to increase its inspection of drug manufacturing facilities in India this year amid growing quality and supply concerns, Reuters reported Tuesday citing an agency executive.

FDA

The FDA on Friday approved Alvotech and Teva’s Simlandi (adalimumab-ryvk), a biosimilar to AbbVie’s blockbuster antibody therapy Humira (adalimumab), ending a long and difficult regulatory road for the partners.

The attorney general for one of the most populous U.S. states this week urged federal drug regulators to address safety risks associated with the widely used asthma and allergy medicine Singulair, saying current warnings on the drug’s packaging are insufficient, particularly for children.

FDA

The FDA has granted Priority Review to Sanofi and Regeneron’s supplemental Biologics License Application seeking to expand its blockbuster antibody therapeutic Dupixent (dupilumab) into chronic obstructive pulmonary disease, the companies announced Friday.

With drug shortages in the U.S. not greatly improving, the Federal Trade Commission and the Department of Health and Human Services announced Wednesday that they are issuing a request for information to look at different groups involved in generic drug supply chains and evaluate how they may be contributing to persistent shortages.

The U.S. Food and Drug Administration on Wednesday approved Johnson & Johnson unit Actelion Pharmaceuticals’ injection, making it the first-ever treatment to treat severe frostbite in adults.

Biogen has disclosed in a Wednesday Securities and Exchange Commission filing that it has been served a subpoena by the U.S. Department of Justice, which is seeking more information regarding the company’s overseas operations.

FDA

The FDA on Tuesday approved Ipsen’s Onivyde, when used in combination with three chemotherapeutic drugs, for the treatment of newly diagnosed patients with metastatic pancreatic adenocarcinoma.

The U.S. CDC plans to drop its five-day COVID-19 isolation recommendations under new guidance planned by the agency, the Washington Post reported on Tuesday.