The U.S. Food and Drug Administration will make public reviews of all data and information regarding the emergency use authorization (EUA) granted to Covid-19 drugs and vaccines.
Novartis won FDA approval for a long-delayed version of Amgen’s $4 billion seller Neulasta drug, helping the Swiss drugmaker in an uphill battle to sell copies of rivals’ blockbusters in the U.S.
Danish drugmaker Novo Nordisk is aiming for a big slice of the multibillion-dollar diabetes market with a new pill approved by U.S. authorities that caters for patients with an aversion to needles.
The U.S. FDA issued a new draft guidance for drugmakers aiming their resources at Fabry disease, a rare genetic disease.
The House Appropriations Committee proposed a 2020 draft fiscal year funding bill. The FDA would receive a 6 percent increase in discretionary funding over 2019, amounting to a $184 million bump.
Two companies that specialize in AI-backed drug development – Insilico Medicine and A2A Pharmaceuticals – are teaming up to take on the rare disease known as Duchene Muscular Dystrophy.
Cambridge, Mass.-based HotSpot Therapeutics burst forth from stealth mode with $45 million in Series A funding to support the development of therapies that will target natural “regulatory hotspots.”
AstraZeneca’s first respiratory biological medicine Fasenra failed to meet its main target in a second clinical trial treating patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
The U.S. FDA granted priority review for Roche’s Perjeta in combination with Herceptin and chemotherapy for treating HER2-positive early breast cancer after surgery.
AstraZeneca forged a research collaboration with Boston-based Berg, a specialist in artificial intelligence for drug hunting.