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The Latest Breaking News from European Medicines Agency

EMA' Advisory Committee Recommends Approval For Roche's Two Cancer Drugs

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended conditional approval for Roche Holdings AG's (OTC:RHHBY) mosunetuzumab for relapsed or refractory (R/R) follicular lymphoma (FL). The opinion covers mosunetuzumab for adult patients who have received at least two prior systemic therapies. The CHMP recommendation is based on…

Benzinga

Britain Approves Moderna's COVID-19 Vaccine For Kids Aged 6-11 Years

Britain's medicines regulator approved the use of Moderna Inc's (NASDAQ:MRNA) COVID-19 vaccine in children between six and 11 years. The Medicines and Healthcare products Regulatory Agency (MHRA) said the approval was granted after Moderna's vaccine, known as Spikevax, met the required safety, quality, and effectiveness standards. Read Next: Why Did Moderna Recall Thousands Of COVID-19…

Benzinga

Valneva Shares Jump As Its COVID-19 Vaccine Receives Conditional Approved In UK

The Healthcare products Regulatory Agency (MHRA) of the U.K. has granted Conditional Marketing Authorization for Valneva SE's (NASDAQ:VALN)COVID-19 vaccine candidate, VLA2001, for primary immunization in adults 18 to 50 years of age. MHRA found that VLA2001 meets safety, quality, and effectiveness standards. This new marketing authorization comes in addition to the emergency use authorization,…

Benzinga

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Europe Holds Second COVID-19 Booster Dose For People Aged Under 80 Years

European Medicines Agency concluded that it is too early to consider using the fourth dose of either Pfizer Inc (NYSE:

Benzinga

Covid travel rules for France, Malta and Portugal as restrictions eased in time for Easter holiday

The travel sector is getting back to normal with thousands up and down the country flying to new destinations each day. But with travel rules constantly updating, what are the latest rules for France, Malta and Portugal?

Edinburgh Live

No Evidence to Support Widespread Use of Fourth COVID Shot, Say EU Agencies

EU health agencies said on Wednesday there was no evidence to support the use of a fourth dose of COVID-19 vaccines developed by Pfizer and Moderna in the general population, but they recommend a second booster for people aged 80 and above. There is no clear evidence in the European…

Asharq Al-Awsat

See Why Did FDA Extend Review Period For Alnylam's Vutrisiran In Amyloidosis

The FDA has extended the review timeline for Alnylam Pharmaceuticals Inc's (NASDAQ:ALNY) marketing application for vutrisiran for transthyretin-mediated (ATTR) amyloidosis. The updated Prescription Drug User Fee Act (PDUFA) goal date is July 14. The FDA needs additional time to review newly added information related to the new secondary packaging and labeling facility for investigational RNAi…

Benzinga

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Novavax asks EU regulator to clear COVID vaccine for teens

The pharmaceutical developer Novavax says it has asked the European Medicines Agency to extend the authorization of its coronavirus vaccine to children aged 12 to 17 amid a surge of disease across the continent

The Independent UK

EMA Starts Review Of Sanofi-GlaxoSmithKline's COVID-19 Vaccine

The European Medicines Agency has started reviewing Sanofi SA (NASDAQ:SNY) and its partner GlaxoSmithKline Plc's (NYSE:GSK) application seeking conditional authorization for their COVID-19 vaccine. The vaccine candidate, Vidprevtyn, was already being evaluated under a rolling review by EMA. The drugmakers had earlier said that they would seek regulatory approval for their COVID-19 vaccine to be…

Benzinga

Novartis Receives Positive CHMP Opinion For Kymriah In Follicular Lymphoma, Jakavi In GvHD

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Novartis AG's (NYSE: NVS)

Benzinga

EMA's CHMP Clears Janssen, Legend's Multiple Myeloma CAR-T Therapy

The European Medicines Agency's CHMP

Benzinga

EMA's Advisory Group Backs Approval For Merck's Keytruda In Various Cancer Settings

The European Medicines Agency's advisory group CHMP has adopted a positive opinion recommending approval of Merck & Co Inc (NYSE: MRK) for

Benzinga

FDA Approves Novartis' Pluvicto As First Targeted Radioligand Therapy For Prostate Cancer

The FDA approved Novartis AG's (NYSE:NVS) Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to treat patients with a type of advanced prostate cancer that has spread to other parts of the body. Pluvicto is a targeted radioligand therapy for adult patients who have already undergone other anticancer treatments. The company said it had submitted…

Benzinga

Moderna Says Infant Covid Vaccine Succeeded in Trial

US biotech firm Moderna on Wednesday said it was pursuing regulatory approval for its Covid vaccine in children under six years old after the two-shot regimen was found to be safe and produced a strong immune response. Specifically, two doses of 25 micrograms given to babies, toddlers and preschoolers generated…

Asharq Al-Awsat

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Benzinga

AstraZeneca's COVID-19 Vaccine Expected To Win European Approval This Week: Reuters

European Medicines Agency is expected to approve AstraZeneca Plc's (NASDAQ: AZN) antibody-based COVID-19 vaccine for preventing COVID-19 infections,

Benzinga

Calliditas Expects EMA's CHMP Opinion For Nefecon In Q2

Calliditas Therapeutics AB (NASDAQ:CALT) says that the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) can be expected in Q2 of 2022. In its review of the marketing authorization application (MAA) for Nefecon, the CHMP has informed us that they will issue an…

Benzinga

NeuroSense Shares Surge Over 400% As FDA Clears Initiating Pharmacokinetic Study Of PrimeC

NeuroSense Therapeutics Ltd (NASDAQ:NRSN) has received clearance from the FDA to initiate a pharmacokinetic study of PrimeC in healthy adult subjects. PrimeC is a novel extended-release oral formulation composed of a fixed-dose combination of ciprofloxacin and celecoxib. PrimeC targets several key mechanisms of amyotrophic lateral sclerosis (ALS) that contribute to motor neuron degeneration,…

Benzinga

Europe Kickstarts Reviewing AstraZeneca Application For Its COVID Antibody

European Medicines Agency has started reviewing AstraZeneca Plc's (NASDAQ:AZN) application for antibody-based COVID-19 therapy but gave no timeline for a conclusion. Infections from COVID-19 are still rising in parts of the world, including Europe. On Tuesday, China posted a steep jump in daily COVID-19 infections, with new cases more than doubling from a…

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France 24

Did the European Medicines Agency say we should stop using Covid-19 boosters?

After a clip from a press conference was published online, questions were raised on social media about the European Medicines Agency's opinion on Covid-19 booster vaccines. Elements of the presser were taken out of context and the EMA's full message got lost in some of the posts. FRANCE 24's Georgina…

Benzinga

European Recommendation On Valneva's COVID-19 Shot Pushed Into April

Valneva SE (NASDAQ:VALN) now expects a positive recommendation from the European Medicines Agency (EMA) for its VLA2001 COVID-19 candidate vaccine in April. Earlier, the Company expected the European recommendation by the end of March. As announced in February, Valneva received a list of questions as part of the CHMP's initial assessment, to which…

The Independent UK

EU clears Moderna shot for young kids, Pfizer boosters

The European Medicines Agency said it has authorized Moderna’s coronavirus vaccine for children aged six to 11, in addition to recommending booster shots of Pfizer’s vaccine for those aged 12 and over

Benzinga

Why Rhythm Pharmaceuticals Shares Are Falling Today

The FDA has extended the review period for Rhythm Pharmaceuticals Inc's (NASDAQ:RYTM) supplemental marketing application for Imcivree (setmelanotide) for obesity and control of hunger with Bardet-Biedl Syndrome (BBS) or Alström syndrome. The Prescription Drug User Fee Act (PDUFA) goal date has been revised to June 16, 2022, from March 16. FDA requested additional subgroup analyses…

Benzinga

Menstrual Irregularities Cases After mRNA COVID-19 Vaccine - EMA Reviews Cases

The European Medicines Agency's safety committee is reviewing reports of heavy menstrual bleeding and absence of menstruation af

Benzinga

EMA's Advisory Committee Recommends Approval Of Blueprint Medicines' Avapritinib In Blood Disorder

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has

Benzinga

Amryt Shares Fall After Oleogel-S10 EMA Regulatory Update

The European Medicines Agency

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