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Cell-based flu vaccines only slightly better than traditional shots in seniors: FDA study fiercevaccines
July 10, 2018
Recent studies have blamed the egg-based vaccine production process for less effective flu shots. But flu vaccines made from the newer, cell-based technology didn't perform much better in seniors last year either, a new FDA report finds.
After nearly 3 years, FDA lifts hold on Aptose cancer drug fiercebiotech
July 09, 2018
The FDA has lifted a clinical hold on Aptose Biosciences’ APTO-253 almost three years after it stopped the blood cancer program. Aptose is now racing to resume dosing patients with the c-Myc inhibitor in the paused phase 1b study.
Cadila scores FDA approval for BMS and Alvogen generics pharmafile
July 06, 2018
The India-based company will manufacture nifedipine ER, a generic equivalent of Alvogen’s Adolat, at its Moraiya manufacturing facility in Gujurat, India.
FDA takes steps to foster greater efficiency in biosimilar development by reconsidering draft guidance on evaluating analytical studies worldpharmanews
July 05, 2018
Today, the agency withdrew the draft guidance, "Statistical Approaches to Evaluate Analytical Similarity," issued in September 2017.
FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy worldpharmanews
July 05, 2018
The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy
FDA approves drug for excessive drooling pharmatimes
July 04, 2018
Merz Neuroscience’s Xeomin has become the first agent to be approved by the US Food and Drug Administration to treat excessive drooling.
Ready to challenge Novartis and Roche, Array scores FDA nod for melanoma combo fiercepharma
June 29, 2018
Twenty years after it began, Array BioPharma has its first two drug approvals, a cancer drug combo that'll transform care for certain melanoma patients, the company's CEO says. But they'll face a couple of heavyweight pharmas in the field.
Zydus Cadila gets US FDA nod for erectile dysfunction drug financialexpress
June 29, 2018
Drug firm Zydus Cadila has received approval from the US health regulator to market Tadalafil tablets, used to erectile dysfunction, in the American market.
Cipla gets US FDA approval for Generic Sustiva financialexpress
June 29, 2018
Cipla has received final approval for its Abbreviated New Drug Application (ANDA) for Efavirenz Tablets 600mg from the United States Food and Drug Administration (US FDA).
FDA accepts BMS’s application for non-small cell lung cancer treatment pharmaceutical-technology
June 28, 2018
The US Food and Drug Administration (FDA) has accepted Bristol-Myers Squibb Company’s (BMY) supplemental biologics licence application (sBLA) for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) to treat first-line advanced non-small cell lung cancer

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