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

5 hours ago
R&D
FDA+

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

4 hours ago
Pharma
FDA+

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

7 hours ago
Pharma
Manufacturing

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

8 hours ago
Pharma

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

Yesterday
Cell/Gene Tx
FDA+

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

8 hours ago
Financing
Startups

FDA OKs new la­bel ex­pan­sions for Dupix­ent and In­cyte's Mon­ju­vi

8 hours ago
News Briefing

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

10 hours ago
Manufacturing

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

12 hours ago
Peer Review

Grail shares jump on study re­sults for can­cer test

2 days ago
Pharma
Diagnostics
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People

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

3 days ago

An­oth­er round of con­sol­i­da­tion is com­ing, FDA com­mis­sion­er tells staff

Last week

Ver­tex lays off 125 work­ers af­ter type 1 di­a­betes cell ther­a­py failed study in March

Last week
Financing

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

2 days ago

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

2 days ago

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

2 days ago
Startups

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

4 days ago

Ex­clu­sive: Com­mons Clin­ic rais­es $26M Se­ries B to of­fer pre­ven­tive test­ing

Last week

Ex­clu­sive: Organoid start­up rais­es $21M to test drugs and vac­cines in hu­man lymph nodes-in-a-dish

Last week
Deals

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

2 days ago

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

3 days ago

NextCure inks ADC deal with Shang­hai drug­mak­er

4 days ago

In FocusSee all

How a tai­lored ALS drug could help broad­en rare dis­ease ther­a­pies

2 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

Last week
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
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

May
16

No­vo Nordisk’s glob­al obe­si­ty leader is mov­ing on; Flag­ship biotech gets CEO from Schol­ar Rock

Pharma channel feed

2 days ago

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

The FDA has ap­proved Gilead Sci­ences’ lenaca­pavir for HIV pre­ven­tion, mak­ing the high­ly-an­tic­i­pat­ed twice-year­ly shot avail­able to peo­ple in the US.

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Com­pounders lose case over semaglu­tide short­age

2 days ago
Health Tech

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

2 days ago
FDA+
latest in Pharma

Q&A: New BIO chair to steer in­dus­try through ‘ex­is­ten­tial threats’ de­spite FDA re­cep­tiv­i­ty

2 days ago
R&D
China

Or­phan drug, PBM changes are ex­clud­ed from Sen­ate ver­sion of Trump tax bill

3 days ago
Law

FDA ap­proves CSL’s pro­phy­lac­tic for se­vere swelling con­di­tion

3 days ago
FDA+

Fired vac­cine ad­vi­sors de­fend ACIP’s work, in­de­pen­dence in joint ed­i­to­r­i­al

3 days ago
R&D

Pur­due opi­oid set­tle­ment gets back­ing from 55 at­tor­neys gen­er­al

4 days ago
Law
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Marketing channel feed

4 days ago

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

2 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

3 days ago

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

A new FDA pi­lot pro­gram un­veiled Tues­day aims to sig­nif­i­cant­ly cut drug re­view times to sup­port what Com­mis­sion­er Mar­ty Makary deems "na­tion­al pri­or­i­ties."

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

4 days ago

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

Last week
Pharma
latest in FDA+

FDA's on­col­o­gy ad­comm to re­view GSK's Blenrep re­launch plans

Last week
Pharma

Mod­er­na wins ex­pand­ed la­bel for RSV shot, al­low­ing use in at-risk, younger adults

Last week
Pharma

Kennedy's vac­cine doubts hinge on 'in­ert' place­bos, but ex­perts say he mis­un­der­stands the sci­ence

Last week
Pharma

In sur­prise, FDA ap­proves Uro­Gen's chemo-turned-gel drug af­ter neg­a­tive ad­comm vote

Last week
Pharma

Ex­clu­sive: Kennedy picks for vac­cine ad­vi­so­ry board were paid ex­perts against Mer­ck in civ­il cas­es

Last week
R&D
Pharma
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Manufacturing channel feed

2 days ago

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

BioN­Tech said it's stop­ping work on an ex­per­i­men­tal cell ther­a­py in cer­tain in­di­ca­tions, and is wind­ing down cell ther­a­py man­u­fac­tur­ing at its Gaithers­burg, MD site.

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

Last week

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

Last week
People
latest in Manufacturing

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

Last week
Pharma

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

Last week
Pharma

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

2 weeks ago
Pharma

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

3 weeks ago

Agenus quick­ly ex­its CD­MO busi­ness by sell­ing as­sets to Zy­dus for $75M up­front

3 weeks ago
Deals
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