Elahere (mirvetuximab soravtansine-gynx), ImmunoGen’s antibody-drug conjugate for ovarian cancer, has received FDA accelerated approval — and the company has already completed enrollment for a confirmatory trial with topline results expected…
The Biden administration has asked a federal judge to dismiss claims that the FDA has intentionally delayed rendering a decision on a Florida proposal to import prescription drugs from Canada.…
The FDA issued a nine-observation Form 483 to ImprimisRx’s Ledgewood, N.J., facility for unsanitary conditions and other deficiencies observed during a July 11 to Aug. 5 inspection. Source: Drug Industry…
Richmond, Va.-based Indivior, maker of the opioid treatment Suboxone (buprenorphine-naloxone), has announced plans to purchase Opiant Pharmaceuticals, a Santa Monica, Calif., producer of the opioid overdose nasal spray Narcan (naloxone),…
The Oregon Attorney General has filed a lawsuit accusing four pharmaceutical companies of filing sham lawsuits to prevent competitors from bringing a lower-priced generic version of their drug to market.…
Roche and its Genentech subsidiary announced disappointing topline data from twin phase 3 trials of their antiamyloid antibody, gantenerumab, for treating Alzheimer’s. Source: Drug Industry Daily
Appco Pharma’s Piscataway, N.J. generic drug manufacturing facility was dinged by the FDA for lacking temperature and humidity records for some equipment and other documentation lapses listed in a five-observation…
In response to requests for a later deadline, the FDA has granted more time to comment on a pair of long-awaited proposed rules on institutional review board (IRB) reviews and…
The FDA has asked GSK to restrict its second-line maintenance indication for its ovarian cancer drug Zejula (niraparib) to patients with deleterious or suspected deleterious germline BRCA mutations, maintaining approval…
The Federal Trade Commission (FTC) has filed an amicus brief in the U.S. District Court for the District of Delaware arguing that some branded drug manufacturers have a history of…