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Ex­clu­sive: FDA's Makary sought re­jec­tion of KalVista’s drug in an un­usu­al move by com­mis­sion­er, sources say

8 hours ago
FDA+

RFK Jr. says he did not com­mit to up­hold­ing ACIP ros­ter to se­cure Cas­sidy’s back­ing

7 hours ago
Pharma
FDA+

For­mer FDA sci­en­tist and psy­che­delics re­searcher hired as CDER deputy di­rec­tor

7 hours ago
People
FDA+

RFK Jr. pledges to keep the US at the cen­ter of the biotech 'rev­o­lu­tion'

7 hours ago
Pharma

Latest

No­vo and Him­s' crossed wires

7 hours ago
Health Tech

Ex­clu­sive: Mikael Dol­sten joins gene edit­ing star­tup's board and eyes 'op­por­tu­ni­ties' with new FDA lead­ers

8 hours ago
People
Startups

Rev­o­lu­tion inks up to $2B 'flex­i­ble' fund­ing deal to ad­vance RAS in­hibitor pipeline

11 hours ago
Financing
Deals

Nek­tar's mid-stage eczema da­ta de­liv­er key win in bid for com­pa­ny turn­around

11 hours ago
R&D

Ar­riVent plots next steps for lung can­cer drug; Neu­ron23's $96.5M raise

11 hours ago
News Briefing

UK gov­ern­ment blue­prints am­bi­tion to be a key life sci­ences hub 

15 hours ago
R&D
Pharma
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People

Act­ing CDER chief is leav­ing af­ter al­most nine years at FDA

Yesterday

Iso­mor­phic to open US of­fice in Cam­bridge, hires ex-Re­lay CMO

Last week

An­oth­er round of con­sol­i­da­tion is com­ing, FDA com­mis­sion­er tells staff

Last week
Financing

Ear­ly-stage in­vestor Syn­cona read­justs pri­or­i­ties due to bleak biotech mar­ket

4 days ago

Ten­nr rais­es $101M Se­ries C to fix fax­es with AI

6 days ago

Ac­tio gets $66M for ex­per­i­men­tal epilep­sy and Char­cot-Marie-Tooth treat­ments

6 days ago
Startups

No­vo ends short-lived part­ner­ship with Hims over com­pound­ed obe­si­ty drugs

Yesterday

Sanofi-backed Welsh biotech se­cures $140M for neu­ropsy­chi­a­try pipeline

6 days ago

Help us find 2025's best biotech star­tups: Nom­i­na­tions are open for End­points 11

Last week
Deals

Il­lu­mi­na to buy So­ma­Log­ic for $350M up­front, push­ing fur­ther in­to pro­teomics

Yesterday

Hu­mana de­tails plans to grow its pri­ma­ry care busi­ness as com­pet­ing clin­ics shut­ter

6 days ago

Lil­ly to bol­ster gene edit­ing pipeline, buy­ing Verve for up to $1.3B

Last week

In FocusSee all

How a tai­lored ALS drug could help broad­en rare dis­ease ther­a­pies

6 days ago
R&D
Discovery

With HIV pre­ven­tion un­der at­tack, how might Gilead’s new PrEP in­jec­tion fare?

Last week
Pharma

Have sky-high sales pro­jec­tions set the obe­si­ty mar­ket up to fail?

Last week
Pharma

Ex­clu­sive: Re­boot­ing dead hu­man brains, a biotech start­up seeks to rein­vent ear­ly drug test­ing work

2 weeks ago
R&D

Endpoints Standouts

Will CRISPR mat­ter?

4 months ago
R&D
Special

Big am­bi­tions at Mer­ck and As­traZeneca — along with a few gi­ant pit­falls — re­shape top ranks of the R&D 15

2 months ago
Bioregnum
R&D

Il­lu­mi­na was built on DNA. Its fu­ture could be bi­ol­o­gy’s next big wave

3 months ago
In Focus
Diagnostics

Where the mon­ey is: The top 100 ven­ture in­vestors in biotech

3 months ago
Financing
Bioregnum

Peer review See all

Jun
20

Roche's ven­ture arm chief to step down in 2026; As­traZeneca obe­si­ty leader has re­tired

Jun
13

Bris­tol My­ers gets a key strate­gist with 'Team Shib­s'; Idor­sia to change CEOs af­ter it 'hit a re­set but­ton'

Jun
6

GSK taps Sanofi vet to lead vac­cine R&D; Bris­tol My­ers names head of cor­po­rate af­fairs

May
30

An­oth­er Bris­tol My­ers ex­ec goes to Aca­dia; David South­well takes CEO job at ARCH-backed can­cer biotech

May
23

Ge­of­frey Porges ex­its Schrödinger with CFO swap; A new board seat for As­traZeneca's Pas­cal So­ri­ot

Pharma channel feed

Yesterday

As­traZeneca, Dai­ichi Sankyo gain lung can­cer in­di­ca­tion for En­her­tu suc­ces­sor

The FDA on Mon­day ap­proved As­traZeneca and Dai­ichi Sankyo’s TROP2-tar­get­ing drug Da­troway in a new lung can­cer in­di­ca­tion, broad­en­ing the amount of pa­tients for what the com­pa­ny hopes is ...

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Supreme Court asks DOJ to weigh in on Hik­ma ‘skin­ny la­bel’ fight against Amarin

Yesterday
Law

CHMP rec­om­mends five new drugs, re­con­sid­ers Eli Lil­ly’s Kisun­la 

4 days ago
FDA+
latest in Pharma

Phar­ma com­pa­nies are weigh­ing how a drug’s IP lo­ca­tion could im­pact tar­iffs

4 days ago
Manufacturing

UK's NICE says Lil­ly, Ei­sai's Alzheimer's drugs aren't worth na­tion­al cov­er­age

4 days ago

Grail shares jump on study re­sults for can­cer test

6 days ago
Diagnostics

Gilead gets ground­break­ing FDA ap­proval for twice-year­ly HIV pre­ven­tion shot 

6 days ago
FDA+

Com­pounders lose case over semaglu­tide short­age

6 days ago
Health Tech
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Marketing channel feed

Last week

Eli Lil­ly makes all Zep­bound dos­es avail­able in sin­gle-dose vials 

Eli Lil­ly said it will make the two high­est dos­es of its pop­u­lar obe­si­ty drug Zep­bound avail­able to cer­tain pa­tients in cheap­er, sin­gle-dose vials.

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HHS says it may re­vis­it an­ti-obe­si­ty drug poli­cies af­ter drop­ping Biden-era pro­pos­al

2 months ago
Pharma
Law

RFK Jr. has long crit­i­cized drug ads. He just slashed the FDA of­fice that reg­u­lates them

2 months ago
Pharma
FDA+
latest in Marketing

J&J touts new sur­vival da­ta pit­ting lung can­cer com­bo against As­traZeneca's ri­val

3 months ago
R&D
Pharma

No­vo Nordisk slash­es We­govy price by near­ly two-thirds for cash-pay­ing pa­tients

3 months ago
Pharma

Mis­lead­ing ex­hib­it booth pan­el lands NJ drug­mak­er an un­ti­tled let­ter from FDA

3 months ago
FDA+

Eli Lil­ly ex­pands Zep­bound sin­gle-dose vial op­tions at low­er price

3 months ago
Pharma

J&J's new can­cer com­bo beats As­traZeneca's Tagris­so on sur­vival in lung tri­al

5 months ago
Pharma
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FDA+ channel feed

Yesterday

The pol­i­tics of vac­ci­na­tion take cen­ter stage as RFK Jr.’s re­built CDC pan­el is set to meet

A new­ly-re­built CDC vac­cine ad­vi­so­ry pan­el will meet for the first time this week, in­form­ing whether the US' pub­lic health agency will con­tin­ue to back da­ta and ev­i­dence that have long ...

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In­side the FDA’s ‘lis­ten­ing’ tour: Of­fi­cials agree US lags be­hind Chi­na on drug de­vel­op­ment

4 days ago
R&D

FDA's top cell and gene ther­a­py lead­ers ex­it agency in on­go­ing CBER changes

5 days ago
Cell/Gene Tx
latest in FDA+

CBER head Prasad adds chief med­ical and sci­en­tif­ic of­fi­cer to his ti­tle

6 days ago
Pharma

FDA ap­proves CSL’s pro­phy­lac­tic for se­vere swelling con­di­tion

Last week
Pharma

FDA un­veils one-year pi­lot to speed some new drugs to mar­ket in just one month

Last week

What's com­ing in five years? FDA chief points to uni­ver­sal flu vac­cine, new ap­proval path­way

Last week

KalVista says FDA de­layed de­ci­sion on HAE drug, cit­ing ‘heavy work­load’ 

Last week
Pharma
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Manufacturing channel feed

4 days ago

En­zene, Ve­r­a­no­va sep­a­rate­ly un­veil ex­pan­sions; Lot­te's new ADC client

Wel­come to End­points News’ man­u­fac­tur­ing briefs, where we bring you es­sen­tial news on new builds, col­lab­o­ra­tions, re­calls and more.

READ MORE

BioN­Tech stops mak­ing cell ther­a­py at Mary­land site af­ter drop­ping germ cell tu­mor in­di­ca­tion

6 days ago
R&D
Cell/Gene Tx

Capri­cor gets Form 483 from FDA; WuXi Bi­o­log­ic­s' new Chi­na fac­to­ry 

Last week
latest in Manufacturing

Biotech slump forces Re­silience to wind down six man­u­fac­tur­ing sites, us­ing bank­rupt­cy move

3 weeks ago
People

In a break from oth­er biotechs, Twist Bio­science throws sup­port be­hind tar­iffs on syn­thet­ic DNA

3 weeks ago
Pharma

Sanofi leans in­to 'first-mover ad­van­tage' by ship­ping Bey­for­tus ear­ly, as RSV an­ti­body mar­ket set to heat up

3 weeks ago
Pharma

Phar­ma im­ports in­to the US re­turn to nor­mal af­ter March tar­iff stock­pil­ing

3 weeks ago
Pharma

Schott Phar­ma's €100M+ Hun­gary ex­pan­sion; An­theia’s $56M Se­ries C raise

3 weeks ago
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