The FDA’s backlog of drug manufacturing facility inspections continues to be a sore spot for the agency, as FDA said Monday that a total of 52 new drug (but no biologics) applications still remain…
Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP…
Hologic is encouraging Black women and their advocates to ‘get loud to get care’ when it comes to uterine fibroids. The medtech company’s new campaign ‘Unmuting Fibroids’ shines a light on the…
Supply chain issues and an inspection backlog have hindered manufacturing’s seemingly endless boom, following an influx of money. But a new threat looms over the industry: a strain of Windows malware.…
Dragonfly Therapeutics is doing better and better in getting Big Pharma on its TriNKET platform. First Celgene, then BMS, and now Merck — again. After Merck licensed its first candidate from the…
The FDA on Tuesday approved Aadi Bioscience’s first drug and the first treatment approved specifically for patients with an ultra-rare and aggressive form of sarcoma that occurs mostly in women. The…
Precision-med biotech Allorion Therapeutics is expanding — and now has tens of millions of dollars more to work with. The Natick, MA-based company announced in a statement this morning that it closed…
One of the biggest projects that Pascal Soriot initiated, all the way back in 2013, after he first took over as AstraZeneca’s CEO is finally complete. AstraZeneca is formally unveiling its $1.34…
Horizon Therapeutics CEO Tim Walbert runs a rare disease company, but he’s also a patient. While his condition hasn’t been a secret, Walbert is stepping out for the first time as the face of rare…
Philips’ latest M&A target, French artificial intelligence developer Cardiologs, received a new FDA clearance that expands the use of its cardiac diagnostic platform into pediatrics. It will be used…
