Regulatory

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...

Bavarian Nordic Receives Mpox Vaccine Green Light From Singapore

Bavarian Nordic announced today that its vaccine, JYNNEOS, has been licensed by Singapore's Health Sciences Authority (HSA) for the prevention of smallpox and mpox...

Ascendis Receives a Grudging FDA Approval for Yorvipath, a Hormone Replacement Treatment

Ascendis Pharma should be in a good position to launch its hormone replacement therapy for hypoparathyroidism in the U.S. market, as it received FDA...

US FDA Rejects Lykos’ MDMA-Based PTSD Therapy

Lykos Therapeutics said that the U.S. Food and Drug Administration (FDA) has rejected its treatment based on the hallucinogenic molecule MDMA for PTSD sufferers,...

Pfizer Releases ABRYSVO for RSV: Top-Line Results in Immunocompromised Adults

Pfizer reported top-line interim safety and immunogenicity outcomes from Substudy B within the MONeT-RSV Immunization Study for Adults, showing that two doses of the...

FDA Approves Ascendis’ Yorvipath for the Treatment of Hypoparathyroidism

Following its approval earlier this week and the scheduled withdrawal of Takeda's injection Naptara from the market later this year due to supply difficulties,...

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Repair Biotechnologies to Leverage Genevant Sciences’ LNP Technology for Atherosclerosis Treatment

Repair Biotechnologies has joined forces with Swiss company Genevant Sciences to gain access to Genevant’s lipid nanoparticle (LNP) technology...

AbbVie’s Parkinson’s Drug Meets Phase 3 Trial Goal

AbbVie has disclosed that its late-stage monotherapy prospect substantially decreased the impact of the condition in patients as contrasted...

AstraZeneca Expands AI-Powered Immuno-Oncology Research Partnership with Immunai

Immunai, a biotechnology company based in New York, has partnered with AstraZeneca in a multiyear endeavor to try and...

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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

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Illumina Decides to Spin Off Grail

An end is drawing close for Illumina's multibillion-dollar pursuit...