Regulatory

FDA Identifies Further Safety Concerns With Intercept’s Liver Drug

The Food and Drug Administration (FDA) has uncovered additional safety concerns related to a medication used to treat a rare liver disease, casting further...

J&J MedTech Gets FDA Nod for Varipulse PFA System

After the FDA approves Johnson & Johnson MedTech's Varipulse technology for the management of atrial fibrillation, the company will join the U.S. pulsed field...

FDA to lift hold over Novavax flu-shot program

Maryland-based biotech Novavax experienced a clinical hold on its late-stage trial of COVID-influenza and standalone flu vaccines after a severe adverse effect, in the...

Astellas and Europe Clash Over Approval of Geographic Atrophy Drug Izervay

Izervay by Astellas and Syfovre by Apellis are the major rivals in the United States Geographic Atrophy (GA) market, but both are struggling to...

New drug Roche to enter breast cancer therapy field

The Food and Drug Administration (FDA) has recently granted approval to Swiss company Roche’s inavolisib for treating HR-positive, HER2-negative breast cancer. The treatment has...

FDA authorizes the first novel schizophrenia therapy in decades

The FDA gave the green light to Bristol Myers Squibb’s much-anticipated schizophrenia drug Cobenfy, the first new chemical entity to treat the severe, chronic...

Illumina Gets Favorable Decision Regarding Grail Acquisition

In a decision expected to limit Brussels' merger authority, American gene sequencing firm Illumina prevailed in court against the European Union's inquiry into its...

Emergent Bio’s Smallpox Vaccine Gains FDA Approval for Mpox

Emergent BioSolutions' smallpox vaccine has received expanded approval from the U.S. Food and Drug Administration (FDA) for use in individuals at high risk of...

Latest news

Ro Partners With Eli Lilly to Offer Zepbound, a Weight-Loss Medication, in Single-Dose Vials

Ro, a direct-to-consumer health and wellness company, has announced a partnership with Eli Lilly to provide discounted single-dose vials...

FDA Identifies Further Safety Concerns With Intercept’s Liver Drug

The Food and Drug Administration (FDA) has uncovered additional safety concerns related to a medication used to treat a...

Corcept’s ALS Modulator Fails to Meet Primary Endpoint in Phase 2 Study

After Amylyx and PTC, Corcept has also decided to withdraw from the amyotrophic lateral sclerosis (ALS) space. Results from...

Must read

Surrounded by controversy, FDA approves Biogen’s Alzheimer’s drug Aduhelm

In the middle of the debate about the Alzheimer’s drug approval, the United States FDA has authorized Aduhelm

You might also likeRELATED
Recommended to you

Aussie pharma CSL in talks to buy Swiss firm Vifor Pharma for USD 7B

CSL, the Australian giant, is in talks...

Amgen’s Drug for Small Cell Lung Cancer Receives US FDA Approval

Recently, the U.S. Food and Drug Administration (FDA) approved...

The European Commission allows Beovu to be used in the Treatment of DME

Following success in Phase III RCT KESTREL...