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The FDA has shot down three citizen petitions seeking agency action on biosimilar labeling, arguing that a draft guidance issued in April is sufficient to address most of their concerns. Read More
The FDA is advising generic drugmakers looking to revise their labels without the fallback of a reference product that they have only one route: supplemental submissions. Read More
Forest Laboratories has decided to bury the hatchet with Teva Pharmaceuticals USA and Mayne Pharma, settling a two-and-a-half year-long patent dispute for undisclosed terms. Read More
The European Medicines Agency is recommending halting sales of 136 drugs whose approval came from flawed bioequivalence studies performed at the Semler Research Centre in India. Read More
The Office of Generic Drugs has taken action on more than 90 percent of its backlog of ANDAs and prior approval supplements, more than 15 months ahead of schedule, CDER Director Janet Woodcock announced in July. Read More
An anticipated uptick in generic drug submissions is leading the FDA to lower its fees for approval applications and supplemental filings next fiscal year. Read More
The UK’s drug pricing watchdog is recommending reimbursement of Celgene’s plaque psoriasis drug Otezla, provided that the company lowers its price. Read More
Less than 24 hours after finalizing its acquisition of Allergan’s generics division, Teva Pharmaceutical disclosed plans to pick up the company’s distribution arm for $500 million. Read More
After nearly two years, the EMA is formalizing its iterative pathway program that saw six applications progress to formal advice from the agency, according to a report. Read More